In a warning letter to the company's CEO and MD Nimish Chudgar, the US Food and Drug Administration (USFDA) has pointed out various manufacturing lapses at the Matoda-Sanand, Ahmedabad-based facility.
The regulator noted that visual inspectors manipulated particle and other defect counts on records to keep the finished product batches within rejection limits
Intas said it is undertaking a detailed analysis on reports of inflammation and has advised doctors to avoid using the product, meant to treat an age-related eye condition, from this specific batch.
Ahmedabad based Intas Pharma which is a closely held company buys Tava's European assets for USD 764 million in an all cash deal. CNBC-TV18's Nisha Poddar spoke with Binish Chudgar, MD of Intas Pharma.
Intas is looking at more acquisitions in US and Europe to strengthen its three main areas of operations - oral solid tablet, oncology, and differentiated patent products, the company's MD Binish Chudgar said.
Intas Pharma is likely to file Draft Red Herring Prospectus (DRHP) with Securities and Exchange Board of India (Sebi), in the next two weeks. It has decided to revive its IPO plan.