The U.S. Food and Drug Administration has issued an import alert banning the import of drugs from Emcure Pharmaceuticals' plant in Maharashtra, India.
The ban was issued because an inspection revealed the plant violated manufacturing standards. Although the import alert does not specify which good manufacturing practice (GMP) was violated, it states that the issue involves the manufacture of some antibiotics, according to in-Pharma Technologist.
Drugs manufactured at Emcure's Maharashtra plant are distributed in the U.S. by Heritage Pharmaceuticals, which is based in New Jersey. Heritage's vice president of marketing, Lew Soars, said the company was "caught by surprise" and is "still trying to assess" the import alert, said in-Pharma Technologist.
In February, Heritage issued a voluntary recall of two products from Emcure—10 lots of Colistimethate and three lots of Rifampin—because the FDA issued an alert about a GMP violation at the manufacturer's plant that was "potentially impacting product sterility."
Emcure is one of the top 20 drug manufacturers in India. In recent years, a number of drug plants in the country have been investigated for standard violations, which tainted the country's reputation as a reliable manufacturer and supplier of generic drugs and affected the advancement of a $15 billion industry, reported Reuters.
Emcure, which primarily makes drugs used to treat infections, cardiac conditions and gynecologic conditions, has nine manufacturing plants, one of which is located in the United States. The drug manufacturer imports to countries in Europe and also to Japan and Brazil. It is a marketing partner to pharmaceutical giants like Roche, Pfizer, Sanofi and Novartis.
