Indoco Remedies: USFDA concludes inspection of sterile facility

The pharma company received four observations from the US Food and Drug Administration (USFDA) for its facility located in Verna, Goa (Plant II). The facility manufactures injectable products.

The audit of the sterile plant was conducte from May 27 to June 4 2019. The USDFA issued 4 observations on Form 483s. These observations are procedural in nature, not pertaining to data integrity, said the company in a press release filed on the exchanges and added that it will soon respond to the observations made by the drug regulator.

According to the management, the inspection was part of a scheduled Prior Approval Inspection (PAI) for Injectable products to be manufacture in this facility. The company is hoping for a successful closure of the audit process and aims to receive faster approvals for its pending ANDAs.

Indoco Remedies is a fully integrated pharma company with nine manufacturing facilities that are approved by various global regulatory authorities. The company has presence in 55 countries.

On Tuesday, the stock of Indoco Remedies Limited closed at Rs. 179.00 per share, down by Rs. 4.10 or 2.24 per cent on NSE.