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Claris Lifesciences receives Letter from the US FDA

21 Aug 2012 Evaluate

Claris Lifesciences has received the letter from the Food and Drug Administration of United States of America (USFDA) stating it has completed the evaluation. The US FDA’s letter cited that it has completed evaluation of the company’s corrective action in response to the Warning Letter WL: 320-11-003, dated November 01, 2010. Based on their evaluation, the US FDA vide their letter dated August 14, 2012, confirmed that the violation(s) contained in the warning letter have been addressed.

The company had received 7 ANDAs approval across 4 products before the warning letter was issued, the company has filed for a total of 32 ANDAs across 21 products which includes niche products like profol and Iron Sucrose. The estimated market size of all products in the United States is about $1 billion.

The company has commercialized sales across 91 countries worldwide and has 1,228 product approvals out of which 207 are in the regulated market and has filed for 357 marketing authorizations under registration out of which 122 are in the regulated market.

Peers
Company Name CMP
Redington 227.50
Adani Enterprises 2228.00
Amrapali Industries 17.36
Rashi Peripheral 474.40
PDS 294.40
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