Caplin Steriles receives USFDA EIR for injectable, ophthalmic manufacturing unit near Chennai

Chennai: Caplin Steriles Ltd, a subsidiary of Caplin Point Laboratories Ltd, today announced that the company has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its injectable and ophthalmic manufacturing unit located near Chennai.

The unit underwent an inspection from US FDA during May 22nd ~ May 31st and the inspection classification was determined by the agency as Voluntary Action Indicated (VAI). VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action

Commenting on the achievement, Mr. C.C. Paarthipan, Chairman said,“This is the fourth US FDA audit at this site and we’re pleased to receive the EIR with a satisfactory outcome. Our commitment to maintaining the highest levels of compliance at all our units remains steadfast. The receipt of EIR will help in receiving continued ANDA approvals for this unit, which is an important growth engine for us”.

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Caplin Steriles Limited is a niche sterile product manufacturing company that is approved by several regulatory agencies such as US FDA. Caplin Steriles Limited, has developed and filed over 31 ANDAs in USA on its own and with partners, with 23 approvals so far. The Company is also working on a portfolio of 55+ simple and complex Injectable and Ophthalmic products, that it intends to file over the next 4 years.

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