CorePharma: GMP Confident, Ready to Relaunch After FDA Closeout Letter

By Dan Stanton

- Last updated on GMT

Related tags Amphetamine

CorePharma: GMP Confident, Ready to Relaunch After FDA Closeout Letter
Three years after receiving a warning letter for GMP violations, CorePharma says it is in a full state of compliance and ready to relaunch products.

The generic manufacturer was on the receiving end of a warning letter from the US Food and Drug Administration in June 2010 that cited a number of violations in cGMP following a 2009-10 inspection of its facilities. However, CorePharma announced last week it has addressed all violations resulting in a closeout letter to the company from the FDA earlier last month.

Speaking with, CEO Stephen White said he now felt “very optimistic”​ about the company’s future. “All the problems have been fixed, but like any organization we continue to evolve and look for ways to strengthen and improve and ensure sustainability in compliance.”

The original warning letter​ identified a number of quality issues in the manufacturing process including: Releasing a batch of Benzphetamine HCI tablets after it failed to meet the established Acceptable Quality Limits (AQL) for coating defects, failing to provide exhaust systems to control contaminants during production, and failing to establish procedures to monitor the output and to validate the performance of manufacturing.

“We obviously took it very seriously as an organization,”​ said White. “We addressed not only the findings in the 483 but put it upon ourselves to develop a Quality Plan.

“We looked at all the quality systems from laboratory, warehouse, manufacturing, packaging, etc and we really did a systematic review of all our quality systems and came up with a list of action items that we developed as a programme to generally improve the site in total. We actually provided that list to the FDA, updated them periodically and frequently on our progress against that plan.”

Impact on Business

CorePharma’s 115,000 square feet site in New Jersey focuses in solid oral dosage forms and and controlled drug products, including generic equivalents of Adderall and Cogentin. The company also does a limited amount of contract manufacturing.

Though production was not halted at CorePharma, business was impacted as some products were taken off the market and the company was unable to launch new products.

Furthermore, the warning letter led to a shortage in CorePharma’s production, frustrating some customers who, according to White, had to make a switch to another supplier.

Bounce Back

With the FDA closeout letter, the company is able to begin the launch of a number of new products.

“We have a number of pending ANDAs which are now going to be approvable, now we are off the warning letter and we have products in development,”​ said White.

He added the firm is looking at its product portfolio, selectively and in a measured way at least initially.

“Once we confirm to ourselves and to the FDA that we can do this effectively and efficiently and compliantly then we’ll maybe accelerate that to a degree. I feel very good about the place and we’re in a very good position at this point.”

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