September 2, 2009 / 5:56 PM / 10 years ago

K-V Pharma: FDA accepts plan to resolve manufacturing issue

Sept 2 (Reuters) - K-V Pharmaceutical Co KVa.N said the U.S. Food and Drug Administration had accepted its work plan to address previously identified deficiencies in its manufacturing practices, sending its shares up as much as 43 percent.

In March, the U.S. Department of Justice sued the drugmaker to block it from making and distributing adulterated and unapproved drugs, after an inspection by the FDA found the company had violated manufacturing guidelines and continued to manufacture unapproved drugs. [ID:nBNG497099]

K-V Pharma has begun implementing certain measures set forth in the work plan but does not expect to resume product shipments before the third quarter of fiscal 2010, it said in a filing with the U.S. Securities and Exchange Commission on Wednesday.

The drugmaker said it anticipates it will request Lachman Consultants, its independent current good manufacturing practices (cGMP) expert, to conduct its certification review later this calendar year.

Upon Lachman’s certification that K-V Pharma is in compliance with cGMP regulations, the FDA will re-inspect the facilities to determine if it is in compliance, the company added.

In preparation for the resumption of commercial production, the drugmaker has begun rehiring certain employees to accommodate the production of verification batches of certain products.

Class A shares of the drugmaker were up 38 percent at $2.98 in afternoon trade on the New York Stock Exchange. It touched a high of $3.09 earlier in the session. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Himani Sarkar)

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