ACERTUS PHARMA PTE. LTD. is a pharmaceutical company incorporated in Singapore. The company is focused on the commercialization, marketing and distribution of specialized and propietary products under exclusive licensing agreements.
ACERTUS is also working on meeting the opportunities and challenges of BioSimilars. ACERTUS has patents for biotechnology-derived products including Interferon Alpha, Beta Interferon, Erythropoietin, Human Insulin and Human Growth Hormone.
ACERTUS has skilled employees working on strategic planning and project execution. Management has in-depth experience in the areas of recombinant protein, molecular biology, bacterial and eukaryotic cell fermentation, protein purification and derivatization, formulation, filling and package design. ACERTUS' team has proven success developing 1st and 2nd generation BioSimilars in established cGMP manufacturing facilities. Back To Top
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, and within a R&D team which has generated 7 process patents while remaining within strict compliance of cGMP rules. Inspected by USA FDA and by AIFA, A.M.S.A., Cosma and its affiliates are presently providing over 20 molecules to the US market and currently hold 25 approved US-DMFs. Back To Top
ANTIBIOTICE was founded in 1955 and is located in Iasi, Romania. ANTIBIOTICE has a large portfolio of over 150 drugs and has extensive R&D and production capabilities. The company has a very large fermentation capacity mainly devoted to Nystatin and are very interested in Custom projects from R&D to commercial.
The product quality of ANTIBIOTICE is backed by certifications including: Good Manufacturing Practice (GMP) for all 8 streams of manufacturing, European Pharmacopoeia Certificate of Suitability (COS), and US Food and Drug Administration (FDA) inspection.
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. Back To Top
APOTEX PHARMACHEM, Canada
APOTEX PHARMACHEM is a global fully integrated API R&D and manufacturing organization with its headquarters located in Brantford, Ontario, Canada and is a member of the APOTEX group of companies.
Currently employing more than 1600 highly-skilled and motivated professionals globally, APOTEX PHARMACHEM has multiple facilities around the world located in Canada (Apotex Pharmachem Canada), India (Srini Pharmaceutical LTD.), Mexico (Signa), and China.
APOTEX PHARMACHEM's capabilities allow delivery of your product requirements on schedule through a comprehensive suite of API services. The company's expert core teams deliver on our customer’s needs for proprietary API processes and manufacturing requirements, novel API salt and crystalline forms, intellectual property protection, analytical chemistry services, technology transfer, regulatory affairs and API registration, quality and compliance, and more.
Over 667 Drug Master Files in Common Technical Document (CTD) format have been prepared and filed by our highly qualified and experienced regulatory affairs teams and DMF submissions have been made in over 49 countries covering more than 118 API's. APOTEX PHARMACHEM'S jurisdictional knowledge and coverage includes the United States, EU (EU Countries) - CEP/MRP, Canada, Australia, Japan, Brazil, Russia, and China. Back To Top
BIOINDUSTRIA L.I.M. was founded in 1932. The company is now 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
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 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
CHR. OLESEN GROUP, Denmark
CHR. OLESEN GROUP is a distribution and sales company with five sectors including: feed, food, pharma, intermediates and veterinary pharmaceuticals. The company serves customers all over the world via their network of subsidiaries and strategically placed warehouses. CHR. OLESEN GROUP is based in Copenhagen and has subsidiaries in Belgium, USA, and Germany.
CHR. OLESEN GROUP has three basic principles that drive their business which include correct product quality, optimal pricing and timely delivery. The company works exclusively with selected principal manufacturers that have proven to consistently meet the standards and demands of different markets. CHR. OLESEN GROUP has developed a quality control system to ensure that products are compliant with the required standards.
In terms of pharmaceuticals, CHR. OLESEN PHARMACEUTICALS is located in Gentofte, Denmark and the subsidiary of CHR. OLESEN GROUP focuses on supplying active pharmaceutical ingredients of the international pharmaceutical industry. Back To Top
CORDEN PHARMA INTERNATIONAL, Germany
Formed as a pharmaceutical branch of International Chemical Investors Group in 2006, CordenPharma provides specialised technologies that are ideal for the development and manufacturing of oral, sterile, highly potent and antibiotic pharmaceutical Drug Products, their Active Pharmaceutical Ingredients, and associated Global Supply Chain and Packaging Services.
CordenPharma is committed to providing flexible solutions for your product success through a legacy of combined API development and contract manufacturing capabilities and specialised technologies in state-of-the-art cGMP facilities. Back To Top
COSMA S.p.A., Italy
COSMA S.p.A. belongs to the CFM Group, a private enterprise involved in chemistry and pharmaceuticals since 1949. COSMA is located in Ciserano (Bergamo) and has been functioning within the group since 1977. Its integrated manufacturing facility is FDA approved, and has the flexibility to widen its product capacity and to harmonize GMP requirements.
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. Back To Top
CRYSTAL PHARMA, Spain
CRYSTAL PHARMA began in 1991 as a R&D company. In 1997, the organization moved to large scale commercial API production. Beginning with a varied portfolio of general APIs, Crystal has moved into other specialty areas with time, including high potency hormones and sterile steroids (by filtration). RAGACTIVES S.L.U has been taken over by CRYSTAL PHARMA and CRYSTAL PHARMA is a business unit of GADEA GRUPO FARMACÉUTICO. The Gadea group gives CRYSTAL PHARMA further financial stability and growth and has positioned Crystal as a key player in global API market.
CRYSTAL PHARMA has a wide portfolio of APIs. They have capacity to supply all size customers, including large multinational organizations. Their sourcing ability in Asia and large manufacturing facility one hour from Madrid, Spain add further stability to their production profile. Contract manufacturing is also a capability, as well as custom synthesis, specializing in complex molecules.
CRYSTAL PHARMA has been inspected successfully by FDA. cGMP certificate has been granted and affirmed by Spanish Ministry of Health. Audits are performed regularly by numerous clients with the highest standards. Back To Top
DERIVADOS QUIMICOS, Spain
DERIVADOS QUIMICOS, S.A.. was founded in January 1987, in Murcia, Spain. In 1990, the company started manufacturing and marketing APIs and advanced intermediates for APIs. In 2008, DERIVADOS QUIMICOS joined the INFA GROUP.
The company has three production facilities and has specialised in the manufacture of chemicals under GMP conditions and according needs of customers (custom synthesis).
DERIVADOS QUIMICOS' facilities and services enable them to perform over 30 different chemical reactions, with a total production capacity of 500 MT per year. The company currently holds the ISO-9001 certification (Quality), the ISO-14000 certification (Environment), the OHSAS 18001 (Safety and Health) and has successfully been US FDA inspected. The trend of DERIVAODS QUIMICOS, 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
With 4 cGMP plants, 500 employees and a portfolio of 70 high quality products, Dipharma is one of the major European producers of Active Pharmaceutical Ingredients, serving a large base of pharmaceutical companies all around the world.
• More than 60 years of experience in handling complex and hazardous chemical
• All of their plants are regularly inspected by US FDA and European Agencies
• About 180 patents or patent applications filed
. Back To Top
ELPEN Pharmaceutical Co. Inc., Greece
ELPEN was established in 1969 and is the leader among purely Greek pharmaceutical companies. The vision of the company is to offer high quality pharmaceuticals for the treatment of disease while striving to effectively contribute to the community and to the Greek economy.
ELPEN specializes in branded generics, and original pharmaceuticals obtained through many collaborations with multinational companies. ELPEN factory headquarters located at Pikermi, Attica, currently covers an area of approximately 10,000 m² in terms of building facilities, on a plot extending over 15,000 m². The company implements strict regulations regarding quality control and quality assurance to ensure successful service.
The goal for ELPEN is to expand their presence in the world, starting with the Balkan countries and moving on to Europe, by taking advantage of Greece's strategic, geographical position, and the company's extensive and innovative product portfolio. Back To Top
EUTICALS was founded in 1984 and is headquartered in Viale Milano, Italy. EUTICALS is one of the leading players in the pharmaceutical and fine chemicals industry. The company has eleven GMP compliant plants located in Italy, France, Germany, UK and USA. The company is also inspected by international and national regulatory societies, such as FDA, KFDA, and ANVISA.
EUTICALS is comprised of 5 companies, including Poli-Industria Chimica acquired in 2010 and Archimica acquired in 2011. With its FDA inspected manufacturing plants and Process Research and Development Centre located in Rozzano, EUTICALS can provide its customers with top quality productions and services at competitive and sustainable prices. The company has a broad portfolio of over 200 APIs covering therapeutic areas including anti-inflammatory, antiarthritic, anticancer, anti infective, antiviral, cardiovascular, central nervous system, hormone replacement, immunosuppressant, neuromuscular-blocking agent, nucleosides and nucleotides.
EUTICALS R&D site has knowledgable scientists that develop and scale-up the industrial processes to be transferred to company’s plants both from proprietary technologies and from external technology transfers.
EUTICALS Corporate Regulatory Affairs offer all the necessary expertise and assistance in order to meet the most demanding and updated worldwide regulatory requirements. Back To Top
FERMIC, S.A. DE C.V., Mexico
FERMIC, S.A. DE C.V., started production in 1968 at its present location in Mexico City. The company operates a U.S. FDA cGMP approved fermentation and synthesis facility and has one of the largest fermentation plants in Latin America. FERMIC's facility has a production capacity of over 1.3 million
litres, and an expansion underway that will increase that capacity to 1.9 million litres.
FERMIC is currently producing and supplying bulk active ingredients for production of pharmaceuticals and is working with customers on production technologies for supplying finished pharmaceutical dosage forms. FERMIC has extensive development efforts focused on strain improvement and production of new biological and chemical products by fermentation and synthesis.
FERMIC also has an on-site R&D department to support their own efforts to become more involved with custom manufacturing of new biological and biotech products. Back To Top
FORMOSA LABORATORIES, Taiwan
FORMOSA LABORATORIES, INC. produces APIs and UV-filters in its modern facilities near Taipei. Its GMP compliance has been approved by DOH of Taiwan, US FDA, BGV of Germany, EDQM and PMDA of Japan. Formosa’s major API products include Vitamin D derivatives (Alfacalcidol, Calcitriol, Calcipotriol, Doxercalciferol, and Paricalcitol), Balsalazide, Benzonatate, Capsaicin, Colesevelam, Gadodiamide, Flupentixol, Melitracen, Meprobamate, Montelukast, Mycophenolate Mofetil, Sevelamer (HCl and Carbonate), and Taltirelin. As a major producer in the world, Formosa's UV-filter products include avobenzone and Octinoxate. The company also provides custom synthesis service from process development to full commercial production for APIs and other specialty chemicals, with full documentation support.
Process development and route optimization are core competencies of Formosa's business. The company has a dedicated staff of professional process chemists and engineers with significant experience and expertise in the development of robust cGMP chemical processes. Back To Top
GLOCHEM INDUSTRIES LIMITED, India
Established in 1996, GLOCHEM is a manufacturer and marketer of APIs and drug intermediates. GLOCHEM is also actively involved in contract manufacturing of finished dosage formulations.
The company has two API production facilities. The first has a building covering 3,000 m² on a land area of 8,000 m². The facility is located in Bollaram, Hyderabad, India and is US FDA, EU GMO and WHO GMP approved. The second facility is a state of the art facility with a building covering 9,000 m² on a land area of 21,000 m². The facility is located in Pharacity, Vizag, India and is US FDA approved and cGMP compliant. GLOCHEM also has COS from EDQM for all the European pharmacopoeia products – Amlodipine Besilate & Cetirizine DiHcl.
GLOCHEM has a committed customer base in India and across the globe. The company has Dynamic Management with a vision supported by an efficient team of qualified and experienced personnel in Manufacturing, R & D, Quality, Regulatory and Marketing. Back To Top
GF SpA, Italy
GF SpA, established in 1979 in the region of Parma, Italy, is ACIC's exclusive partner in North America for pharmaceutical equipment. GF has acquired extensive knowledge and experience in designing and manufacturing hi-tech washing, sterilization, filling, ISBM, and inspection systems for the pharmaceutical, cosmetic, nutraceutical and personal care industries. Focused on the ever-changing business environment, GF SpA is capable of identifying needs, and supporting them with reliable and high quality innovative processing and packaging solutions. GF SpA is accredited as a "Laboratory of Industrial Research" through the Italian Ministry of Education, University and Research. Back To Top
PHARMACEUTICAL CO. LTD., China
HAINAN HAILING PHARMACEUTICAL CO. LTD. is part of the Hailing Pharma group in China and was founded in 1992. The company is located in Haikou, Hainan, China. HAINAN HAILING is engaged in the R&D, manufacturing and marketing of API and formulated drugs.
With major equipment imported from Germany, the United States, Japan and Sweden, HAILING PHARMA's highly automated production lines manufacture a wide range of antibiotics such as powder injection, freeze dried powder injection, water injection, capsules, granules, and oral liquid. All of HAINAN HAILING's production lines have gained national Certificate of Good Manufacturing Practices.
The company has an extensive network of distributors in 31 provinces and autonomous regions across China. HAINAN HAILING also plans to export pharmaceutical products to developed markets. Back To Top
HANGZHOU ZHONGMEI HUADONG PHARMACEUTICALS CO. LTD., China
HANGZHOU ZHONGMEI HUADONG PHARMACEUTICALS CO. LTD. is one of the core company of Hangzhou Huadong Medicine Group Co.,Ltd. The company was incorporated in 1992 and is located adjacent to West Lake in Moganshanlu, Hangzhou, China.
HANGZHOU ZHONGMEI HUADONG is a comprehensive pharmaceutical company that integrates traditional Chinese medicine, western medicine, bio-tech products, APIs and finished dosage forms. The company has GMP compliant facilities including microbiology fermentation equipment, chemical synthetic equipment and capsule, tablet, dried suspension, oral solution, injection, aerosol, soft-gel capsule, and lyophilized powder production facilities. HANGZHOU ZHONGMEI HUADONG also focuses on quality by implementing state-of-art control systems.
HANGZHOU ZHONGMEI HUADONG has passed GMP certification of products, ISO14001 Environmental Management System certification, USA FDA inspection, Australia TGA inspection and EDQM COS certification of key products. Back To Top
HEC PHARM GROUP GLOBAL, China
HEC Pharm, established in 2002, is a subsidiary of HEC Group, a Chinese research-based and internationally oriented company with worlwide distribution.
With a history of excellence in research development and manufacturing of active ingredients and finished products in Asia, Europe and the United States, all products meet the current regulatory requirements of local and/or international GMP standards. Many products are EU and US FDA approved. The company's goal is to improve the health of people by providing them with high-quality, safe, and user-friendly products and medicines. Therapeutic areas include infectious, cardiovascular, oncology, metabolic, and CNS, with select biologics in the pipeline. Back To Top
ICROM SpA was established in 1969 and in 1996 was acquired by the French chemical group Proxis Developpement SA. The company is located in Concorezzo, Milano, Italy. ICROM specializes in manufacturing active pharmaceutical ingredients and intermediates with GMP compliant facilities.
ICROM 's modern GMP manufacturing facilities comprise of several units. Two units are dedicated to manufacture active pharmaceutical ingredients and intermediates. A third unit (KILOLAB) is dedicated to the production of small scale, high value products, usually contract manufacturing, custom synthesis projects. A fourth unit includes a full glove-boxed area which is devoted to small scale manufacturing of niche high-potency API's. The facilities are regularly inspected by the Italian Regulatory Authority (AIFA). All operating processes are duly GMP certified.
ICROM operations are based on broad experience in applying its own technologies as well as the technologies developed by its sister company FAR CHEMICAL, Inc. to serve worldwide pharmaceutical outsourcing.
The Quality Control Program conforms with all major international standards. It is staffed by experienced and qualified chemists to guarantee the highest quality level of products. Back To Top
ION EXCHANGE, India
ION EXCHANGE pioneered water treatment in India and is today the country's premier company in water and environment management, with a strong international presence. Formed in 1964, as a subsidiary of the Permutit Company of UK, we became a wholly Indian company in 1985 when Permutit divested their holding. We currently employ 1,000 people - multi-disciplinary teams of highly experienced professional managers technologists and scientists, supported by a widespread infrastructure in India and abroad.
ION EXCHANGE also produces resins, membranes, polymers and polyelectrolytes for water and speciality non-water applications. Cholestyramine Resin USP, as drug carrier or active ingredient, is one of this company's products for use in the pharmaceutical sector. Back To Top
IPCA is a fully-integrated Indian pharmaceutical company that was founded in 1949 and has been continuously evolving over the last 60 years. The company partners with health care facilities in over 110 countries from areas including North America, Africa, Asia, Australia and Europe.
IPCA is one of the world's largest manufacturer and supplier of over a down API's. The API's are produced at the company's six manufacturing facilities that have been inspected by various drug regulatory authorities including US-FDA, UK-MHRA, EDQM-Europe, Japan-PMDA, and WHO-Geneva.
IPCA is one of the top pharmaceutical companies in India. They are among the leaders of the Indian pharmaceutical market for many therapeutic areas. For anti-malarials, IPCA leads the Indian market and is continuously expanding into the international market.
At IPCA, they are committed to being a responsible neighbour. The company has implemented an Environment, Health and Safety management system that ensures their operations comply with laws and regulations. Back To Top
IRIX PHARMACEUTICALS INC., United States
IRIX PHARMACEUTICALS INC. was founded in 1996 and is located in South Carolina, United States. The company is a privately held company engaged in the generation of process technology for new and existing drugs. IRIX offers the full capability of supplying API’s and complex pharma intermediates from pre-clinical stages, through all phases of clinical trials, registration/validation batches, launch and ongoing commercial quantities.
IRIX operates three sites for Process R&D and Clinical through Commercial cGMP production of API’s. Process R&D and early stage clinical supply for API’s is based in Florence, South Carolina. This facility is smaller-scale with equipment that measures up to 2,000 L. Late-stage clinical supply and commercial production is located in Greenville, South Carolina. This facility is large-scale with equipment measuring up to 24,000 L.
IRIX's client base includes North America, Europe, Asia and Australia. IRIX ensures compliance with all regulatory and quality requirements internationally. Both the Greenville and Florence site were visited by the FDA in 2008 and 2009, respectively, with no 483s issued for either site. IRIX has been a reliable and trusted partner of the health care industry with a history of proven government regulatory compliance for well over a decade. Their outstanding FDA inspection record is a reflection of their focus on quality. Back To Top
JIWA BIO-PHARM HOLDINGS LTD, China
JIWA BIO-PHARM HOLDINGS LTD. was established in 1987 and is located in Hong Kong, China. , JIWA began as an agent for a number of European pharmaceutical companies. Now, the company, through its subsidiaries, is engaged in the research, manufacturing and trading of pharmaceutical and health care products.
The Company’s subsidiaries include Jiwa Development Co. Ltd., Jiwa International Limited, Jiwa Pharmaceuticals Limited, Tech-Medi Development Limited, Jiwa Rintech Holdings Limited, Sino-Tech International (Macau Commercial Offshore) Limited, Jiwa Pharm & Chemicals Limited, Yunnan Jiwa Biotech Limited, Rise Hill Development Limited and Base Affirm International Limited.
JIWA's product offerings include antibiotics, gastrointestinal, rheumatology, orthopaedics, over the counter (OTC) drugs, health care products, and their own branded products. Throughout the years, they have developed specialties in the anti-infectious, gastrointestinal, and musculoskeletal therapeutic categories. In recent years, they have concentrated on the development of antidepressant, psychiatric disorder, and cerebro-cardiovascular drugs.
The company is currently transitioning from a generic pharmaceutical company to a specialized pharmaceutical company. JIWA plans to continue to strengthen their business in developing, trading and exporting drugs to international markets. Back To Top
LABOCHIM was founded in 1966 and is located in Milan, Italy. It is the manufacturing unit of INFA Group, which has over 50 years of experience in the marketing and sales of API's throughout the world. Today, Labochim is a modern API production unit with a production capacity of 170,000 L.
The facility continues to be successfully inspected by FDA since the late 70’s, and represents a strategic asset of the INFA Group. The plant covers a surface area of 11,000 m2, of which 5,000 m2 are dedicated to buildings and facilities.
Offices in the world include: Italy, France, Germany, Switzerland, and the United States. LABOCHIM has a highly skilled R&D team, with over 25 years of successful cooperation with Milan's Organic Chemistry University. The company has a 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. It is available to support small volume APIs, custom synthesis and contract research projects, scale ups and IND/NDA applications with clinical trial quantities.
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. Back To Top
M3 GLOBAL TECHNOLOGIES, Canada
M3 Global Technologies, Inc is an agent and distribution company with a focus on brand and niche products in the USA and Canada. M3GT blends corporate and entrepreneurial experience with a common sense approach and has a strong track record in the commercialization of niche brands, diagnostics, critical care, infectious disease, and oncology support products. M3GT provides, through its associates, expertise in sales and marketing, market access, regulatory services, and GMP distribution capabilities. Back To Top
NCPC (North China Pharmaceutical Group Corporation) was established in 1953 and is a leader in global antibiotic technology and production. Products include antibiotic bulks and formulations, vitamins and nutrition products, biotech products, immunosuppressants, pesticides, and veterinary drugs.
Development of bio-pharmacy is NCPC’s new strategic orientation and by utilizing its technological advantages accumulated in the field of traditional fermentation (antibiotics) since 1984, NCPC has initiated modern biotech research and set up a bio-tech drugs development system involving new product R&D, pilot scale, and industrialization. Back To Top
Pancap Inc. is a nationally recognized contract manufacturing organization located in Markham, Ontario, Canada. The company was founded in 1993 by a group of principals with combined 100+ years of service in the pharmaceutical industry. Pancap began its contract manufacturing operations in January of 1994 and offers to its global clients a wide range of manufacturing and support capabilities including capsule fabrication, compounding of non-sterile liquids, packaging, labelling, regulatory affairs, testing, and quality assurance. Back To Top
SCL Group, India
SCL GROUP was established in the early 1990’s and is located in Panchukla district, Hayana, India. The company's main business areas are:
- Manufacturing of Bulk APIs and Intermediates
- Custom Manufacturing and Custom synthesis
- Trading in APIs, Pharmaceutical Intermediates
- Speciality Chemicals Business Division.
SCL offers a wide variety of Active Pharmaceutical Ingredients and Intermediates to its customers worldwide. SCL’s products are exported to Europe, the United States, Asia and Latin America.
SCL’s manufacturing facilities have been built to comply with EU GMP and U.S. FDA norms, and the API facility has been successfully certified as EU GMP compliant five times by the European Authorities.
Aside from manufacturing, SCL also operates as a full pharmaceutical trading and distribution business. Their participation in areas across the pharmaceuticals industry ensures firsthand, leading-edge knowledge and bolsters their strength as a partner to customers and suppliers alike. Back To Top
SENOSIAIN is a privately held pharmaceutical company that was founded in 1928. The corporate offices of the company are located in Miguel Hidalgo, Mexico City, Mexico, which is where the pharmaceutical industry of Mexico is most strongly concentrated. The company also has a plant located in Celaya, Guanajuato, Mexico.
SENOSIAIN is focused on manufacturing and marketing quality pharmaceutical products. The company imports, exports, manufactures, develops and trades bulk pharmaceuticals. SENOSIAIN is one of the largest pharmaceutical companies in Mexico. Back To Top
SIFAVITOR has produced active pharmaceutical ingredients and their intermediates for the pharmaceutical industry since 1966. The company is located in Milan, Italy and has a production plant located in Casaletto Lodigiano, Lodi, Italy.
The multipurpose cGMP plant covers a surface area of 23,000 m2. The plant runs on a continuous basis and is used for production of over 70 different active pharmaceutical ingredients. There is a production capacity of 120,000 litres for small or medium-sized batches.
SIFAVITOR has always been focused on high quality standards. The company has been FDA inspected since 1977 and ISO 9000 (now 9001:2000) certified since 1998. All active ingredients are produced under GMP and always comply with official pharmacopoeias such as USP, Ph. Eur, BP and JP.
SIFAVITOR is a member of the INFA GROUP along with Labochim, Derivados Quimicos and Kylolab. Together, INFA GROUP has over 50 years of experience in the marketing and sales of API's throughout the world. Offices in the world include Italy, France, Germany, Switzerland and the USA. Back To Top
SIGNA is an Active Pharmaceutical Ingredients company located in Toluca, Estado de Mexico, 40 miles west of Mexico City.
SIGNA, along with Apotex Pharmachem Inc., Apotex Pharmachem India (PVT) LTD., Apotex Pharmachem (Tianjin) Inc., Apotex Fermentation Inc., Blue Treasure and Srini Pharmaceuticals Ltd, are the companies that together form the Apotex Pharmachem Group.
SIGNA's multiproduct and multipurpose cGMP facility has four productive plants and a total reaction capacity of 94,800 gal. The range of the volumetric capacity ranges from 300 to 3,000 gal. The plant has the capacity to produce 35-40 different final products and their intermediates. SIGNA, along with Apotex Pharmachem Group's other companies, is US-FDA inspected and approved. The plant was also designated a "Clean Industry" by the Mexican Environmental Protection Agency due to their commitment to integrating safety, health and environmental practices into their business activities. Back To Top
SMS PHARMACEUTICALS LTD., India
SMS PHARMACEUTICALS LTD. is one of the leading pharmaceutical manufacturing companies in India with world-class facilities, with a wide range of process equipment fully compliant with the cGMP and WHO Standards. SMS has a strong research and manufacturing team supported by state of the art facilities that meet the requirements of USFDA and WHO cGMP.
Having started as a single facility manufacturing a single product in 1990, SMS has grown to be a global player in API manufacturing with multiple locations and with products spreading across an array of therapeutic segments. With capabilities in a wide range of APIs / intermediates, SMS can handle varied process reactions and reactor volumes up to 15KL.
SMS's commitment to quality and productivity, which is acknowledged by an ever expanding list of global clientele, is reflected in their implementation of total quality management processes at every stage of the manufacturing life cycle. Back To Top
SRINI PHARMACEUTICAL LTD., India
SRINI PHARMACEUTICAL LTD. was established in 1995. The company is a US-FDA and TGA approved company located near Hyperabad, South India.
SRINI is engaged in the exports of active pharmaceutical ingredients and drug intermediates to regulatory and non-regulatory markets. The company has five full-fledged production facilities. The total capacity of the plant is 276 KL with 10 independent class 100,000 clean room areas to produce 360 MT of API's and 640 MT of intermediates per annum. SRINI also has a state-of-the-art centralized quality control and research and development lab.
SRINI belongs to the Apotex Pharmachem Group. Back To Top
THERAPEUTIC PROTEINS INTERNATIONAL LLC. (TPI), USA
TPI is a world-class commercial manufacturer and supplier of finished biosimilar recombinant therapeutic proteins products. The corporate offices and manufacturing facility of TPI are located within the University Technology Park of the Illinois Institute of Technology in Chicago, Illinois.
TPI's products are manufactured in cGMP/BLA compliant facilities using proprietary and patented technologies for both mammalian and bacterial expression systems. TPI is preparing to supply US FDA-approved biosimilar cytokines and monoclonal antibodies to help reduce the cost of treatment to patients worldwide.
TPI's manufacturing technology is revolutionary and protected by dozens of patents. The facility is designed to meet all current and future requirements of biological manufacturing of drugs. The highlights include:
- Molecule-specific independent and isolated suites
- Class 100K upstream and class 10K downstream (cold) rooms
- Proprietary upstream (fermentation) systems: 20L to 40,000L
- 100% single-use manufacturing systems
- Futuristic utility systems: Double RO/EDI water system, product flow and CIP systems Back To Top
TRIFARMA S.p.A., Italy
TRIFARMA S.p.A. was established in 1958 and is an international and independent group with the missions to develop, manufacture and supply worldwide high quality API's to the global pharmaceutical industry.
TRIFARMA is located in Milan, Italy. In order to further improve its presence in the globalized pharmaceutical marketplace, TRIFARMA merged with two Italian API factories. These manufacturing sites are now known as TRIFARMA Manufacturing Site - Ceriano Laghetto and TRIFARMA Manufacturing Site - Rozanno. TRIFARMA has also established a strong technical and marketing cooperation with ALCHYMARS ICM SM PVT. LTD. (abbreviated as AIS), located in Chennai, India. All sites operate under GMP's, are FDA approved, and fully adhere to ICH guidelines.
The Ceriano Laghetto site has an area of 5,000 m². This facility specializes in high value/low volume products and in process development from grams to hundred kg lots. The Rozzano site has an area of 5,000 m². This multipurpose plant is famous for its production of Phenothiazine and antihistaminics. The AIS site located in India has an area of 8,800 m². This site has 4 sections. The first is a multipurpose plant, and the other three are dedicated to the manufacturing of Clindamycin HCl, Hormones and Steroids, and bulk sterile Iyophilized Horomes/ Steroids respectively. Back To Top
VKT Pharma Private LTD., India
VKT Pharma, a Quality driven pharmaceutical company with a strong matrix of capabilities is presently focusing on research, development, manufacturing & marketing of Ready to fill pre formulation intermediates of Immediate & Modified release pellets for a wide range of generic drug formulations in various Therapeutic segments.
They are committed to strict adherence towards cGMP norms as well as their efforts towards continuous improvement of the product, process and the skills of their work force.
. Back To Top
ZACH SYSTEM, Italy
ZACH SYSTEM was established in 2007 and is headquartered in Bresso (MI), Italy. ZACH SYSTEM is the fine chemicals subsidiary of ZAMBON COMPANY S.p.A (est. 1906).
ZACH SYSTEM is a fine chemicals company to providing its customers with fast, cost-effective, quality custom synthesis services, API's and intermediates. The company also provides support supporting them with extensive process development expertise.
ZACH SYSTEM has two cGMP production facilities located in Lonigo, Italy and Avrillè, France. In addition to their manufacturing capabilities, each facility also contains dedicated R&D and commercial activities covering both Custom synthesis and Generic API production.
As a subsidiary of the holding company Zambon Company S.p.A., ZACH SYSTEM continues to offer complementary pharmaceutical services while enjoying the stability that comes from being part of a leading multinational company that has been in business for over 100 years. Back To Top