THE PROBLEM

A U.S. generic pharmaceutical manufacturer wanted to enter a lucrative market segment and had conceptually developed a formulation for a target product.

The product was a narrow therapeutic range product and it was critical that the properties of the active ingredients be identical to those of the referenced product.

To complicate matters, the innovator had locked–up the only source of the raw material.

THE SOLUTION

ACIC research chemists were quickly able to duplicate the molecule.

Next, through one of the many FDA-inspected facilities at its disposal, ACIC took the molecule through scale-up from pilot to commercial quantities.

So, very quickly the generic company had an approvable product within all the innovators specifications.

ACIC then entered into an exclusive agreement with the generic company to supply the previously unattainable raw material.

THE OUTCOME

Despite the precision needed to emulate a narrow therapeutic range product and despite the efforts of the innovator to keep the product off the market, ANDA approval is achieved in the first review.

The ANDA holder is still unchallenged in the generic market, and to date no other fine chemical maker has been able to make the raw material.

In the first week of marketing the generic company received
$10 million in orders for their new product.

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THE PROBLEM

A multi-national pharmaceutical manufacturer experienced large, unforeseen increases in the sale of one of its new products. Production capacity constraints forced them to divert their attention to fulfilling the manufacture of the new product thus creating a gap in the supply of one of their flagship products.

THE SOLUTION

ACIC is asked to supply, within a month’s lead time, sufficient supply of the flagship product to supply markets in several countries.

Aided by the fact that ACIC’s products were registered in all of the countries required, the material was immediately injected into the client’s international dosage manufacturing facilities.

During the process, the client audited the plant chosen by ACIC for this project and found no deficiencies. The shipments arrived on schedule.

THE OUTCOME

The client was able to achieve uninterrupted supply of both crucial products without compromising its production facilities. Revenue flows were not disrupted.

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THE PROBLEM

A U.S generic pharmaceutical manufacturer wanted to enter the beta-blocker market with a niche product.

Due to the relatively low volumes of the potential market, there was little room for a lot of competitors.

The generic company was aware of only two companies who were developing the product – ACIC being one of them.


THE SOLUTION

ACIC is chosen as the exclusive supplier to the generic company. The plant chosen for the project passes FDA inspection the first time.

The product becomes the first entry for this plant into the U.S. market.

THE OUTCOME

The other fine chemical company is unable to develop a validatable process and none of the ANDA applicants who file using their product are approved.

The generic company gains market exclusivity for the duration of their supply contract with ACIC.

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THE PROBLEM

A European bulk antibiotic manufacturer wants to make a first entry into the U.S market with a product.

The company knows it’s ahead of its competitors, but also that its window of opportunity is small and early market share is crucial to long term success.

THE SOLUTION

ACIC, through the efforts of its sales team, positions the product with several large U.S. generics.

ACIC then convinces the antibiotic manufacturer that it can sell the product at nearly double the initial price planned by the manufacturer.

The antibiotic manufacturer subsequently becomes the primary supply source at each of the generic companies where ACIC introduced the new product.

THE OUTCOME

The cushion from the early profits enables the antibiotic manufacturer to comfortably follow the inevitable price decline that comes as more competitors enter the market.

After nearly ten years in the market the price per kilo of the product reached the level at which the antibiotic manufacturer originally first wanted to enter with.

However, the most important outcome has been the same generic clients have placed other products with the manufacturer and its place in the U.S. market is now established.

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THE PROBLEM
ACIC was approached by the Canadian Ministry Of Health to solve the problem of supplying a parasympathomimetic broncho-constrictor agent to the Canadian market.

There were other producers of the agent, however their quality was not consistent.

THE SOLUTION

ACIC’s manufacturing network was quickly able to produce an extremely pure product.

So pure in fact that the original manufacturer of the branded version of the drug approached ACIC to supply the pharmaceutical grade bulk.

The supply situation had disrupted the manufacturer’s brand (a major European multi-national) and was causing a migration of customers to the base chemical) and it quickly became an unpromoted, under performing product.

ACIC formed an affiliate market company with specially credentialed and trained sales force designed to relaunch the brand at all levels of distribution and all professional users throughout North America.

This company then entered into a royalty arrangement with the multi-national for the North American marketing of its brand.

THE OUTCOME

The growing sales figures confirm the successful
re-establishment of the brand’s value.

FDA reportage continuously confirms the reliability of the source.