From Molecule to Market

AIS, India

AIS is a fusion of Italian high technical expertise and regulatory experience with Indian entrepreneurial skills creating an unprecedented successful joint venture in the manufacturing field of Active Pharmaceutical Ingredients (API’s) and it intermediates. AIS is composed of several companies including Gen Phar Pro Investments (GB) Limited, Alchymars S.p.A., I.C.M S.p.A and Sai Mirra Pharma Group.

AIS strength lies in the manufacture of API's and its related intermediates which are complex in synthesis, in a range from low to high-volume and medium/high value. Facilities are GMP certified as per WHO Guidelines with well drawn Quality policy and Quality Assurance Protocols manned by trained team of experts. AIS has two manufacturing facilities with four dedicated manufacturing sections specializing in synthetic API's (multipurpose), non Beta-lactam Antibiotics, Steroids/Hormones and Sterile Bulk API's Lyophilisation.

Facilities are capable of handling wide range of chemical reactions such as:

• Grignard
• Catalytic reduction
• Condensation
• Chlorination
• Bromination
• Amidation
• Reduction
• Cyclisation
• Diazotization

A spacious Research and Development Lab with well-equipped in-house Pilot plant has been integrated to work in coordination with AIS’s Italian R&D team. Also featured is an ultra modern and fully-equipped in-house analytical testing facility with state-of-the-art analytical instruments. Facilities possess well-designed Environmental protective measures in place with zero-discharge concept. Functioning as an extended manufacturing arm of the joint venture company, ALCHYMARS ICM SM PRIVATE LIMITED, Chennai, India is poised for a consistent growth year after year, at a rate much higher than the industry average.
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ALCHYMARS, Italy

ALCHYMARS S.p.A. was established in 1958 and has a long history in the development and manufacture of Active Pharmaceutical Ingredients (API) for human and veterinary use.

ALCHYMARS specializes in high value / low volume products and in process development from grams to hundred kilogram lots.

The manufacturing unit consists of a multi-purpose organic synthesis plant that operates under cGMP in accordance with strict regulatory requirements and in compliance with local environment regulations. Back To Top

AMSA, Italy

A.M.S.A. S.p.A. belongs to the CFM Group, a private enterprise involved in chemistry and pharmaceuticals since 1949. Functioning within the group since 1953, A.M.S.A operates FDA inspected factories specializing in the production of pharmaceutical active ingredients for regulated markets. The increasing success of A.M.S.A. S.p.A. is grounded in a team of high-level chemists with long-standing experience of the pharmaceutical process, within a R&D team which has generated 7 process patents and while remaining within strict compliance with cGMP rules. The total A.M.S.A. production capacity is 56,000 litres, with stainless steel and glass lined reactors having a capacity range of 1,000 to 3,000 litres. Inspected by USA FDA and by AIFA, Cosma and its affiliates are presently providing over 20 molecules to the US market, hold 25 approved US-DMFs. The ability to discover new paths of synthesis and in developing new molecules on behalf of customers, complete the picture of the skills which A.M.S.A. strives to place at the pharmaceutical industry’s disposal.

With over 45 years of existence and development, ANTIBIOTICE, located in Romania has extensive R&D and production capabilities. They have a very large fermentation capacity mainly devoted to Nystatin and are very interested in Custom projects from R&D to commercial. Back To Top

ANTIBIOTICE, Romania

ANTIBIOTICE is a cGMP facility and during July 2002, the facility was successfully inspected by the US Food and Drug Administration (FDA) with no FDA 483 form issued.

In addition, they have several large manufacturing facilities for dosage forms including oral, topical, injectable and suppository production which is supported by a large local sales force detailing Ethical and Generic products. ACIC has filed three product ANDAs and is continuing to file additional products on behalf of ANTIBIOTICE. Back To Top

APOTEX PHARMACHEM, Canada

APOTEX PHARMACHEM has emerged as a leader in the development and manufacture of active pharmaceutical ingredients for the global pharmaceutical community.

They are located in the City of Brantford, Ontario, Canada and are proud of their state-of-the-art facility. Included in the most recent expansion has been an additional 20,000 square feet of R&D laboratory space and state of the art equipment, to double their Research & Development capabilities.

Over 20 commercial products, more than 30 commercially valuable patents granted and the ability to handle 25 discrete projects at any one time testify to their in-house specialties. Back To Top

ARCHIMICA

ARCHIMICA is a privately held pharmaceutical fine chemical company with sales of more than US$ 150 million (2008) and 600 employees at seven manufacturing facilities in Italy, France, Germany, Great Britain and the United States of America. Most of our sites are FDA-inspected and operate under cGMP conditions.

• Focus and products. ARCHIMICA focuses on starting new projects in clinical phases II and III and on new generic drug development.
• Major customers. Decades of experience in custom synthesis of high-tech building blocks,intermediates and APIs in close cooperation with our clients make us a preferred supplier to major pharmaceutical companies and multiple biopharmaceutical companies, e. g. five of the top 10 global pharma companies.
• New Business Development. ARCHIMICA’s dedicated NBD business unit develops and scales about 50 new products with close to 200 chemical steps every year. We operate four pilot plants and four R&D centers.
• Broad technology base. Besides decades of experience in pharmaceutical fine chemicals, ARCHIMICA has a good reputation and long track record in “modern chemistries” like enzymatic, chiral, organometallic, heterocyclic, nucleoside and hydrogenation chemistry and in hazardous chemistries, e. g. nitrations.

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BILIM PHARMACEUTICALS, Turkey

BILIM PHARMACEUTICALS –Employing 1761 people and reaching an annual turnover of over $300 million, Bilim has become the 3rd largest company in Turkey among national and multinational manufacturers. Bilim offers global partnership opportunities ranging from Contract Manufacturing, Distributorship/Agencies, In-Licensing agreements for its potential partners. Bilim organizes the production supply chain from two manufacturing facilities. Their Cerkezkoy Plant is the 3rd largest B-Lactamic plant in Europe. Their new Gebze Plant (an investment of over 70m²) is currently under construction in Istanbul according to FDA guidelines. This plant will be operating through the last quarter of 2007 with an annual capacity of 125m pack/year. Back To Top

BIOINDUSTRIA, Italy

BIOINDUSTRIA L.I.M. is able to offer both a large range of finished active ingredients in bulk for the pharmaceutical industry and the development of specialized custom synthesis for "highly demanding" customers.

The activities of the company are:

• Production of large volume I.V. Solutions
• Production of Generics
• Manufacturing and marketing of bulk active ingredients for the pharmaceutical industry
• Manufacturing and marketing of flavours and fragrances

The manufacturing of API is carried out at their recently constructed plant in Fresonara near Novi Ligure.

Established with the intention of supporting its own pharmaceutical activities, the Fresonara plant has in a short time, improved the efficiency of the overall organization by increasing its production capacity.

All products are supported by DMF's that are filed in house by BIOINDUSTRIA L.I.M. staff.

BIOINDUSTRIA'S Quality System has been recognized by the FDA (the last approval on July 2001), following an inspection of the plant and their analytical laboratories; as well as many successful audits by major Italian and foreign pharmaceutical companies and their respective countries’ Health Authority.

BIOINDUSTRIA L.I.M. is always accessible to customer’s audits. Back To Top

Hunan Kangyuan Pharmaceutical Co. Ltd., China

Hunan Kangyan is one of the three subsidiaries of ChinaSun Group. The Hunan Kangyuan company specializes in pharmaceutical manufacturing and is located on the heart of HuNan province, Changsha city and is a leading enterprise in the pharmaceutical sector that is comprised of three distinct organizations; manufacturing equipment (Pharmaceutical Machine Co. Ltd.), manufacturing pharmaceuticals (KangYuan), and pharmaceutical packaging (Novel).

ChinaSun Machinery not only builds simple operation, high efficiency pharmaceutical equipment for pharmaceutical procession but they also offer production lines that include Non-PVC membrane I.V. multi-chamber bags, plastic bottle infusion, plastic bottle ampoule, glass bottle high-speed infusion, injectables, compact ampoule line, oral liquid, antibiotics, opthalmics, bottle filled syrup and suppository manufacturing product lines.

ChinaSun Novel specializes in the research, development and manufacturing of a number of packaging products including; multiple layer non-PVC membrane, plastic containers for intravenous fluid using PPC stoppers and caps, connectors, suppository packages and plastic bottles. ChinaSun currently owns more than 150 patents and is committed to continuous development. The key to ChinaSun's success is their efficient management system, sophisticated technology and excellent production plants. Their mission statement is "Providing excellent products and services for the consumer." Back To Top

CAPMATIC, Canada

For over 42 years (since 1964) Capmatic Ltd. Has been successfully designing and manufacturing innovative packaging solutions and systems for business around the world. Capmatic has been providing task-suited packaging and production solutions to the Pharmaceutical, Health Care, Cosmetic, Nutritional, Food & Beverage and Chemical Industries. Time honoured tradition and craftsmanship, combined with today’s technology make Capmatic a leader in the Packaging Industry. Back To Top

COSMA S.p.A., Italy

COSMA S.p.A. was founded in 1977 and is located in Ciserano (Bergamo). Its integrated manufacturing facility is FDA approved, and has the flexibility to widen its product capacity and to harmonize GMP philosophy.

COSMA is specialized in the organic synthesis of Active Pharmaceutical Ingredients (API) and their strategy is to dedicate a portion of their production capacity to custom manufacturing with selected pharmaceutical companies.

The synergetic work of the R&D departments gives Cosma more capability to study and develop new routes of synthesis in a short time, with the submission of new patents. Their strategy is to invest in the growth of their R&D department capability and in new technologies.

COSMA is a strong believer in ensuring friendliness to the environment. They own an important partnership in a municipal wastewater treatment plant and an additional partnership in a large incineration plant for chemical waste. An innovative system for biological wastewater treatment has been in place since the end of 1997. COSMA holds twenty-five (25) approved US-DMFs. Back To Top

CRYSTAL PHARMA, Spain

CRYSTAL PHARMA is an independent Spanish company specialising in the development and manufacture of steroids for the pharmaceutical industry. Its outstanding manufacturing facilities are located in the “Parque Tecnológico de Boecillo” 150km to the north of Madrid and well supported by an excellent communications system.

CRYSTAL PHARMA’s manufacturing facilities have been designed from the outset in accordance with FDA guidelines. The “clean room” for the physical treatment of the final products, has been specifically designed in accordance with approved pharmaceuticals standards. The facilities also include a modern well-equipped pilot plant which permits the development of efficient and reliable processes which take into account and respect the environment. Back To Top

DK PHARMA, India

DK PHARMA is a dynamic entity, manufacturing various Specialty, Fine Chemicals and Intermediates since 1980; meeting the needs of national as well as international customers with continuous development.

Their state-of-the-art manufacturing plant, equipped with modern production facilities is located 40 kilometers from Mumbai and is now venturing into the manufacturing of Active Pharma Ingredients. This WHO cGMP-compliant facility is supported with dedicated quality control and research and development departments which are responsible for continuous innovations in products and processes. DK PHARMA’s dedicated team of analytical chemists ensures product conformity to the highest analytical standards. Back To Top

DERIVADOS QUIMICOS, Spain

DERIVADOS QUIMICOS, S.A.. was founded in January 1987, in Murcia, Spain, and in 1990, the company started manufacturing and marketing APIs and advanced intermediates for APIs. The company has specialized in the manufacture of chemicals under GMP conditions and according to our clients' demands (custom synthesis) including: Acylation, Alkylation, Amidation, Diazotation, Cannizzaro, Carboxylation, Catalytic reduction, Chloromethylation, Chlorosulfonation, Condensation, Cyanation, Diels-Alder, Epoxidation, Esterification, Etherification, Friedel-Crafts, Grignard, Halogenation, Hydrogenation, Methoxylation, Methylation, Neutralisation, Nitration, Oxidation, Reduction, Saponification. Derivados Químicos' facilities and services enable them to perform over 30 different chemical reactions, with a total production capacity of 500 MT per year. Additionally, Derivados Químicos uses special reagents such as PCl3, POCl3, SO4(CH3), SOCl2, BuLi, NaH, NaBH4, LiAIH4, etc. The company currently holds the ISO-9001:2000 certification (certification body: AENOR), ISO-14000 certification, and has successfully been US FDA inspected. The trend of Derivados Químicos, S.A. to date has been of constant growth and improvement, exhibiting great flexibility in the variety of products and increased production capacity. Back To Top

EUTICALS, Italy

The EUTICALS Group consists of 4 companies concerned with the development and production of intermediates and APIs with different production technologies.

All the companies belonging to EUTICALS group run their activities in accordance with current GMP regulations requested by competent authorities, and have been FDA inspected.

EUTICALS began its operations in 1984, with the acquisition of the chemical division of Istituto Chemioterapico Italiano S.p.A. a chemical-pharmaceutical company founded in 1946 in the present location of San Grato (Lodi). The facility has a surface of 23,000 sqm. It has been recently renovated and its reactors and vessels total 200,000 liters. EUTICALS is a qualified supplier of bulk pharmaceuticals as well as active ingredients for the pharmaceutical and nutritional industries. It produces drugs, which are used in the field of anti-ulcers, treatment of central nervous system illnesses, infections of the respiratory tract and other disorders. Pharmaceutical intermediates with its own and / or custom technologies are also manufactured. Currently EUTICALS produces approximately 500 tonnes / year of pharmaceuticals, active ingredients, nutriceutical and intermediates. Euticals meets cGMP and G.L.P standards as well as environmental protection requirements (according to EC regulations). The Company recently underwent a successful FDA inspection.

AMBROSIA, thanks to its research and pilot development structure and capability, is able to produce the small quantities necessary for the pharmacological development and registration of a new molecule; at the same time AMBROSIA can work out an industrial production process to be transferred to the other companies of the group (Euticals or Prochisa), as to satisfy customer needs when launching the product in the market.

During years of increasing activity, PRO.BIO.SINT. has instead pursued the production of ribonucleic acid and deoxyribonucleic acid derivatives. Thanks to its experience PBS can produce key intermediates and new sophisticated “antisense” molecules. The technologies available from PBS, ranging from synthesis to enzymatic and fermentative processes, are new and advanced.

Thanks to their volumetric capacity, EUTICALS and PROCHISA can evaluate and satisfy exclusive API production proposals with different and sophisticated process technologies. Back To Top

FINETECH LABORATORIES, LTD., Israel

FINETECH PHARMACEUTICAL LTD., a subsidiary of Landela Pharmaceutical (formerly known as RxElite, Inc.), focuses on development and production of low volume, high value specialty Active Pharmaceutical Ingredients and Intermediates.

FineTech offers a full range of services from paper chemistry to laboratory scale development through to pilot scale and commercial production. In support of these services they also offer analytical method development, regulatory affairs, and complete literature and patent analysis. FineTech is staffed with a team of professional scientists who have vast experience in synthetic and analytical chemistry with expertise in chiral and prostaglandin chemistry. FineTech operates on a 35,000 sq. foot, 6 building campus, equipped with state-of-the-art laboratory, production and quality control equipment. Their FDA registered facility has the equipment versatility and unique operational capability to serve a wide variety of challenging requirements including controlled substances.

FineTech Pharmaceutical Ltd., strives to give their clients and partners a valuable advantage in the marketplace by:

• providing turnkey development to manufacture solutions including literature and patent analysis and regulatory support
  
• providing a “by-pass" to process patents by developing a non-infringing process which can be patented in its own right
  
• producing products of the highest quality and purity
  
• rapid scale up from bench to commercial manufacture
  
• providing unique solutions to develop novel synthetic routes for a broad range of complex chemicals

FineTech utilizes a flexible approach in structuring business with their clients and partners in order to maximize the value for all parties. By understanding the risks and reward potential for each opportunity they believe they can find a path that best fits market conditions and meets each party’s objectives.

FineTech — Providing unique development services and complex API’s to create value for their clients. Back To Top

FERMIC, S.A. DE C.V., Mexico

FERMIC, S.A. DE C.V., started production in 1968 in its present location in Mexico City, with a fermentation capacity of about 100,000 liters.

Over the years the initial capacity has increased ten fold, making Fermic one of the largest antibiotic fermentation plants in Latin America and by the end of 2002 this capacity will have grown further still to a level of 1.4 million liters.

The complete plant is in s/s 304 & 316 and is "MULTIPURPOSE" which means it can produce a variety of products by fermentation for oral and sterile injectable grade.

The plant also includes important multipurpose facilities for the synthesis of antibiotics and other products.

The plant is FDA / USA approved since 1971 and the last inspection was in May, 1996.

PILOT PLANT:
5 x 500 liters fermentors plus related prefermentors.

FERMENTATION COMMERCIAL CAPACITY:
900,000 lts. plus related prefermentors.

RECOVERY:
3 recovery systems:

• By precipitation
• By resins
• By solvents

FERMIC has an important R&D unit for strain development and improvement and for new biological and chemical products by synthesis.

FERMIC is interested in considering customers’ manufacturing of biotechnological products. Back To Top

FORMOSA LABORATORIES, Taiwan

FORMOSA LABORATORIES, Inc. was established in 1995 as a contract research laboratory specializing in chemical process development, analytical service, and small scale production.

Since inception, their business has been expanded to include the commercial production of API’s /advanced intermediates and other high value-added specialty chemicals.

With their strong experience in process validation, scale-up capability, and flexible cGMP manufacturing facilities (50-1,000 L), FORMOSA is aiming at becoming a major player in custom synthesis. FORMOSA commits itself to the manufacture of all its pharmaceutical products in accordance with cGMP (ICH Q7A) and by the methods described in specific drug master files . They have been inspected / audited by local authorities, local and foreign companies and have now been successfully inspected by the US FDA and are ISO 9001 certified. To date, Formosa holds 16 US-Drug Master Files (DMFs). Back To Top

GENETIC S.p.A., Italy

GENETIC, S.p.A. – Genetic’s prime business strategy is to develop generic drugs and offer complete dossiers for finished dosage forms. Genetic S.p.A. was born with the objective to develop and to manufacture unit dose in Polyethylene or Polypropylene and pressurized metered dose inhaler (p MDI) for anti-asthmatic products, ophthalmological drugs, nasal products, OTRL, solutions and suspensions. Today, Genetic’s new factory is ready with a total area of 13,000 m², comprising 4,500 m² of cGMP-designed production facilities, with a daily capacity of 5000,000 unit doses. In 2008, Genetic will be working towards successful FDA approval. In addition to these physical products, Genetic also actively markets their research and development skills, and expertise with regard to sterile manufacturing and the registration of active pharmaceutical ingredients (steroids). Back To Top

GLOCHEM INDUSTRIES LIMITED, India

GLOCHEM– Established in 1996, Glochem is a manufacturer & marketer of APIs, drug intermediates, OPC/OLED and fine chemicals. They also are actively involved in custom synthesis as well as contract manufacturing. Glochem is particularly proud of their low senior management turnover, resulting in efficiencies that enable easier and quicker development. Glochem recently successfully participated in a U.S. FDA inspection. Back To Top

HAINAN HAILING
PHARMACEUTICAL CO. LTD., China

HAINAN HAILING PHARMACEUTICAL CO. LTD., is a private-owned comprehensive enterprise engaged in R&D, Manufacturing and marketing of API and formulated drugs.

With major equipments imported from Germany, the United States, Japan and Sweden, Hailing Pharm’s highly automated production lines manufacture a wide range of medicines as powder for injection, lyophilized powder for injection, small-volume water injection, capsules, tablets and suspension and all of them have gained national Certificate of Good Manufacturing Practices.

Hailing Pharm also builds up cooperative relationship with pharmaceutical industries from Japan and Korea. In 1993, Hailing Pharm and Shionogi cooperated to manufacture the patent medicine Shiomarin and in 1996, Hailing Pharm and Hanmi cooperated to produce the patent medicine Tazime.These two products have now become its leading products. Back To Top

HANGZHOU ZHONGMEI HUADONG
PHARMACEUTICAL CO., LTD., China

A subsidiary of Hangzhou Huadong Medicine Group (established 1952), HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. was established in 1993. This comprehensive pharmaceutical company is engaged in research and development, manufacturing and marketing of fine chemicals, APIs, intermediates, bio-products and formulations. HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. attaches great importance to the innovation of new and promising products. Back To Top

JIWA BIO-PHARM HOLDINGS LTD, China

Established in 1987, JIWA BIO-PHARM HOLDINGS LTD. began as an agent for a number of European pharmaceutical companies. It was there they developed their own sales network and product development teams and gained regulatory affairs experience. This became their core strength and competitive advantage as they demonstrated a high success rate of product registrations and shortened production lead times when launching new products.

In 1993, JIWA began developing and manufacturing a wide range of generic pharmaceutical products, launched in the European market with proven results. These products were created in their own manufacturing plant located at Yunnan - known as a center of excellence for the Chinese pharmaceutical industry and the core for major government development of China’s Western region. JIWA has received a number of awards in recent years recognizing their achievements in management, product development, technology and quality.

JIWA’s product offering includes a full range of antibiotics, gastro-intestinal, rheumatology and orthopaedics, and the production of over the counter (OTC) drugs, health care products, as well as their own branded products. Throughout the years, they have gained insight in the industry and developed specialties in the anti-infectious, gastro-intestinal, and musculo-skeletal therapeutic categories. In recent years, they have concentrated on the development of antidepressant, psychiatric disorder, and cerebro-cardiovascular drugs.

A 2004 business expansion resulted in the building of a new plant at the Kunming National Hi-technology Industry Development Zone. This new complex has a gross floor area of approximately 38,000 sq. meters and 13 GMP production lines for finished dosage forms and APIs.

In 2005, JIWA expanded into API manufacturing and established Jiangsu Jiwa Rintech Pharmaceutical Co. Ltd (JJRP). This facility is located in the Jiangyin municipal of the Jiangsu province, long a leading area for chemical synthesis and pharmaceutical industry in the People’s Republic of China. The company endeavours to develop into a major international API manufacturer, producing sophisticated APIs for regulated markets, including the United States and European Union. Within the first phase, a two-production complex for oral APIs and sterile cephalosporin bulk was set up, with total area of 43,900 square meters and an investment of 95M (RMB). This facility produces a number of products including Citalopram, Risperidone, Cefipime and Cefpirome, some with DMFs already submitted to the FDA. The company has state-of-the-art production technologies, with exceptional emphasis placed on safety, health and the environment.

Looking ahead, JIWA will continue to strengthen their business in trading and developing drugs with existing molecular formulae within their core therapeutic categories, as well as cultivate their expertise in the development of their patent products and bulk materials for export into the international market. Back To Top

LABOCHIM, Italy

LABOCHIM s the manufacturing unit of INFA Group, with 50 years experience in the marketing and sales of API's throughout the world. Offices in the world: Italy, France, Germany, Switzerland, U.S.A. Labochim was founded in 1966 by Dr. Ruggero Cardoso together with other partners. At that time there was only one 1,000 liter reactor in the plant. Today LABOCHIM is a modern API production unit, with a 170,000 liter production capacity. The facility continues to be successfully inspected by FDA since the late 70s, and represents the strategic asset of the INFA Group, an entity engaged for over 50 years in the worldwide marketing and sales of API’s.

In June 2006 INFA Group executed an investment agreement with one of the major and most qualified Italian Private Equity Funds – Investitori Associati – who became the major shareholder of the group.

LABOCHIM is proud of their highly skilled R&D team, with over 25 years of successful cooperation with Milan's Organic Chemistry University. Labochim’s state of the art laboratory with equipment ranging from 100 ml to 24 litres and dedicated analytical instruments.

LABOCHIM’s Macrolab operates in compliance with cGMP's, available to support small volume APIs, custom synthesis and contract research projects, scale ups and IND/NDA applications with clinical trial quantities. 3 glass reactors of 100 litres each fully equipped: to carry out special reactions requiring accurate, visual control of the process to use particularly aggressive reagents and products to perform reactions at temperatures ranging from -10°C to +150°C to handle very active products thanks to the filters and air control system operating in the dedicated finishing area.

LABOCHIM’s core business: Production
The plant covers a surface area of 11,000 m², of which 5,000 m2 are dedicated to buildings and facilities. Multipurpose cGMP plant allows for dedicated production lines. Production runs on a continuous basis. Processing operations are performed in a closed system. Total reactor capacity of 170m³ with 45 reactors ranging from 160 to 10,000 litres and a tankyard (above and below surface) of 425 m³ . Suitable and up to date facilities for safety and preservation of the environment which include:

• Physical-chemical waste water treatment plant
• Two post incinerators for polluted fumes, one of which is equipped with steam
• Producing system for energy saving
• Blowdown system for unexpected emissions
• Stripper for treatment of industrial waste water
• Rectifying column for solvents recovery

Key technologies include:

• Industrial diafiltration process by means of selective membranes
• Alkylations
• Dealkylations
• Halogenations
• High vacuum distillations
• Phase transfer reaction

Finishing department
A specific area with separate rooms for isolating finished products and handling of powders, consisting in: dedicated hydro-extractors for each individual product dedicated driers including static, rotating, turbo and filter driers dedicated mills and micronizers to satisfy special particle size requirements Air treatment with 95% efficiency inlet filters where air is not recycled but expelled via absolute filters with 99.9% efficiency to prevent environmental pollution.

Quality and Compliance - a Top Priority: QA - QC and Regulatory Affairs
Strengths of this department can be summarized as follows:

A team of young, skilled analysts. Up to date analytical techniques including:

• Liquid chromatography
• Ionic chromatography
• Gas chromatography
• Spectrophotometrical analysis
• Potentiometric titrators
• D.S.C.
• P.s.d. determination (sieve, microscope, laser light scattering)
• Polarimetry
• Routine Quality Team meetings for evaluation and continuous improvement of the quality system
• Personnel training courses on cGMPs, safety issues, and current legislation concerning APIs
• Regulatory Affairs section in contact with Health Authorities; preparation and Submission of DMF documentation
• Complete technical assistance to customers to support registrations worldwide
• FDA inspections since the late 70s

Where the future starts: Research & Development
A highly skilled R&D team, with over 25 years of successful cooperation with Milan's Organic Chemistry University. State of the art laboratory with equipment ranging from 100 ml to 24 litres and dedicated analytical instruments.

Products & Technologies

• Acylation
• Alcoholysis
• Alcoxilation
• Alkilation
• Bromination
• Carbomethylation
• Chlorination
• Dehalogenation
• Sandmeyer reaction
• Transfer phase reaction
• Dealkylation
• Diazotisation
• Diels Alder reaction
• Epoxydation
• Formylation
• Friedel Crafts reaction
• Mannich reaction
• Optical resolution
• Reactions w/ arom. amines
• Reactions with hydrides
• Vilsmeier Haack reaction

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LAFRANCOL, Colombia

LAFRANCOL manufactures and distributes high quality pharmaceutical products, (Ethical, Generic and OTC) as well as nutraceuticals, nutritional supplements and functional foods for Colombian and international markets. Lafrancol’s highly qualified, certified employees and facilities have shown a dedication to the preservation of the natural environment as well as the resources utilized in the manufacturing processes. Back To Top

ORIT LABS, USA

Orit Laboratories specializes in generic pharmaceutical product development. They are focused on the analytical and formulation development of solid oral dosage forms. Orit’s 9000 square foot facility, located in West Caldwell, NJ is capable of pilot scale production and their analytical laboratory operates under cGMP. They aim to be a premier product development company forming alliances with pharmaceutical manufacturers and marketers. Novel oral drug delivery, specialty/niche products, NDA 505(b)(2), patent challenges and brand life-cycle extensions as well as technology transfers are some of the business activities that Orit applies their expertise to. Back To Top

POLPHARMA S.A., Poland

POLPHARMA S.A. is located in Starogard, Gdansk, Poland. The Company was founded in 1935 and is the leading pharmaceutical company in Poland and one of the top pharmaceutical companies in Central/Eastern Europe.

POLPHARMA manufactures a wide range of active pharmaceutical ingredients (APIs) and API intermediates. The Company operates under cGMP rules (current Good Manufacturing Practice), and has been FDA inspected.

Production capabilities range from laboratory scale, to pilot plant, to full-scale production of several hundred metric tons, depending upon the chemistry involved. The Company is also continually looking at developing new and interesting API’s.

POLPHARMA currently has 22 APIs filed with the U.S. Food and Drug Administration. The Company has been selling its APIs in the United States for more than 10 years, and is looking forward to increasing its presence in this market. Back To Top

RAGACTIVES, Spain

Ragactives is a Spanish fine chemical company dedicated to the development and manufacture of non-steroidal APIs. Ragactives is a quality and market driven organization. In March 2007, Ragactives chemical plant was audited and approved by the FDA. Ragactives has aligned their management systems and decision-making processes with their goal of meeting customer needs within the shortest period of time. In addition to APIs, Ragactives is involved in chemical synthesis/analysis as well as synthetic organic chemistry. Back To Top

SANOVEL, Turkey

SANOVEL was established in 1983 by Pharmacist Erol Toksoz and has grown to be the flagship company within the core business of Toksoz Group; manufacturing, marketing and distributing pharmaceutical products. SANOVEL promotes its product offering throughout Turkey using a large field force of skilled medical representatives.

SANOVELmanufactures over 150 human and veterinary products in a state-of-art facility of 40,000 m². With employees numbering close to 2500, including 330 highly-qualified personnel specializing in production, SANOVEL’s corporate identity is also the pride of its employees.

Moving up in IMS rankings to be among the top ten companies over the last decade, SANOVEL has a proven success record of developing and introducing the first generics of major products to the Turkish market. SANOVEL’s dynamic product portfolio is continually being renewed and expanded according to new trends in treatment. This portfolio consists of branded generics of cardiovasculars, analgesics / anti-inflammatory drugs, antibiotics, antihistaminics / decongestants antihistaminics / decongestants, gastrointestinal system and central nervous system drugs.

Making significant investments into R & D, using the strength of a large and dedicated team of specialists, SANOVEL is an industry leader in the Turkish generic industry. Back To Top

SCL GROUP, India

Established in early 90's, SCL built its business working alongside large Indian Pharmaceutical Companies like Ranbaxy, Lupin etc. Progressing rapidly from intermediates to API manufacturing, SCL has established several strategic alliances in the domestic and international markets. Focusing on international markets, SCL manufacturing facilities have been built to comply with EU-GMP and USFDA norms. In keeping with the times, SCL has taken initiatives in growth areas like Biotechnology. All trading activities now being upgraded to into Distribution and Logistics business.

SCL's main business areas are:

• Manufacturing of Bulk APIs and Intermediates
• Custom Manufacturing and Custom Synthesis
• Trading in APIs, Pharmaceutical Intermediates
• Biotechnology Division: Custom Research in Antibodies, Recombinant Proteins,
  Elisa Kit development, Multifuntional Microarrays, Oligoarays etc.
• Speciality Chemicals Business Division.

SCL Group's Vision includes becoming an internationally recognized supplier of APIs and Pharmaceutical Intermediates to the regulated markets. Back To Top

SIFAVITOR, Italy

SIFAVITOR S.r.l. has produced fine chemicals and their intermediates for the pharmaceutical industry since 1966. Thanks to the outstanding versatility of the equipment and the vast experience of its highly skilled personnel, the company’s output, consisting of small/medium size batches, comprises a large range of active principles.

In the course of a year, the company produces over 40 chemical substances. Facilities meet GMP’s requirements and US Code of FDA plants, and is regularly inspected and approved.

Their specific technology consists of high-pressure reactions, such as condensation and catalytic reductions, which are made possible by means of autoclaves operating at pressures of up to 100 Atm.

The plant also has 25 fully equipped glass-lined and stainless-steel reactors with blanketed centrifuges, some dedicated to specific reactions (i.e. Grignard or Alkylation). A specially equipped distiller is set to work under vacuum – up to 250 degrees Celcius.

The manufacturing unit consists of vacuum dryers, vibrating sieves and a dedicated section with a mill and a micronizer.

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SIGNA, Mexico

SIGNA is an Active Pharmaceutical Ingredients company located in Toluca, Estado de Mexico, 40 miles west of Mexico City.

SIGNA has positioned themselves among the most important API manufacturers in Latin America with products that exceed USP and BP market requirements and standards. The facility is FDA approved and manufactures high value products such as AZT (AIDS treatment).

Every effort at SIGNA seeks compliance with cGMP’s and local / international regulatory agencies rules. It validates its processes in the plant and trains all personnel for cGMP’s. Quality Control and Quality Assurance are vital for SIGNA as they ensure that their API’s are manufactured meeting the highest quality standards.

The manufacturing area is divided into six (6) production plants covering 139,895 square feet with modern and secure facilities which provides Signa with the flexibility required to produce its variety of products. Back To Top

SMS PHARMACEUTICALS LTD., India

SMS Pharmaceuticals Ltd. is one the leading pharmaceutical manufacturing companies in India with world-class facilities of nearly 625,000 square meters located in a bustling industrial/commercial area. These facilities feature a wide range of R&D and process equipment–fully compliant with cGMP and WHO Standards.

SMS Pharmaceuticals works with their clients to become a preferred partner for contract manufacturing, custom synthesis and development of API and advanced intermediates. As a value-added business partner or associate, SMS is committed and focused on meeting and exceeding expectations with a high degree of quality and integrity.

SMS’s commitment to quality and productivity is reflected in the implementation of total quality management processes in every stage of the manufacturing life cycle and this is demonstrated by SMS’s ever-expanding and global list of clientele.

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TRIFARMA S.p.A., Italy

TRIFARMA S.p.A. is an international and independent group with the mission to develop, manufacture and supply worldwide high quality APIs (Active Pharmaceutical Ingredients) to the global pharmaceutical industry. Thanks to its rather small size and its very active R&D and marketing teams, TRIFARMA is particularly fast in the decision-making process, which produces an extremely short period from lab-to-industrial scale development.

In order to further improve its presence on the globalized pharmaceutical marketplace, the two Italian API factories (formerly named Alchymars SpA and ICM Industria Chimica Milanese SpA) have merged into TRIFARMA SpA, thus creating a larger and industrially, commercially stronger organization.

TRIFARMA SpA (and its two incorporated factories) belong to the UK Group Gen.Phar.Pro Investments Ltd, which controls also the Indian factory Alchymars ICM SM Pvt Ltd (abbreviated as AIS) located in Chennai, India. All the three factories are FDA approved. Back To Top

ZACH SYSTEM, Italy

ZaCh System, established in 2007 and headquartered in Lonigo (Vicenza), is the fine chemicals company of Zambon Company (est. 1906). This relationship benefits from the solidity and synergies of a large multinational group with the focused intent of a dedicated fine chemicals company. ZaCh System is involved in advanced intermediates for custom synthesis. They are also engaged in R&D and manufacturing as well as the marketing of bulk active ingredients and APIs for the generic market. Supported by over one hundred years of experience, this new enterprise, ZaCh System, combines industry-leading quality with tailored process support to ensure clients meet and exceed their objectives. Back To Top