Caplin Steriles Ltd, a subsidiary of Caplin Point Laboratories Ltd, on Monday announced that it 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 company announced through an exchange filing.
The unit underwent an inspection from US FDA during May 22nd to May 31st and the inspection classification was determined by the agency as Voluntary Action Indicated (VAI).
“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," said C.C. Paarthipan, Chairman.
Caplin Point Laboratories Ltd shares
The shares of Caplin Point Laboratories Ltd on Monday at Rs 1,079.90, down by 1.50 percent.
About Caplin Steriles
About Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories 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.