FDA clears wave of foreign manufacturing plants as COVID-19 concerns continue to grow

Lupin, Dr. Reddy's Laboratories and Biocon all received FDA go-aheads at facilities in India and Malaysia. (Pixabay)

U.S. eyes have turned abroad as the coronavirus crisis raises concerns about the safety of the global drug supply. In moves that could shore up confidence, the FDA has given a trio of overseas generics plants the all-clear to produce. 

Lupin Pharmaceuticals, Dr. Reddy's Laboratories and Biocon all received clean FDA reports at manufacturing facilities in India and Malaysia. 

On Monday, Lupin said it had received an establishment inspection report (EIR) for its oral solid dose facility in Nagpur, India, following an inspection in mid-January.

Free Webinar

Building a Flexible, Challenge Resistant and Patient Centric Clinical Supply Chain

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. In this webinar, learn the benefits of utilizing demand-led supply and direct-to-patient distribution models in the clinical supply chain, as well as how they can be used to both improve flexibility and better align with patient needs. Register today!

The all-clear came after the facility was knocked with two observations in an FDA Form 483 received in January, Lupin said. The investigation, which took place between Jan. 16-20, was the seventh at Lupin's Nagpur site. Overall, Lupin has 15 manufacturing sites.

Dr. Reddy's, meanwhile, received an inspection report earlier this month for its API facility in Telanga, India after receiving a Form 483 (PDF) with three observations stemming from an inspection in March. 

Also earlier this month, Biocon reported (PDF) the FDA had closed pre-inspection for for its insulin glargine plant, tagging the facility with a voluntary action indicated, a rating that indicates the facility meets at least the minimum FDA standard. 

That finding followed a February inspection that resulted in a Form 483 with three observations. Biocon called the latest FDA decision “an endorsement of our commitment to global standards of Quality and Compliance.” 

A fourth company, Strides Pharma, said in late March it had a received an EIR for its flagship facility in Bangalore, India. 

RELATED: After 'initial shock,' generics supply chain likely to weather COVID-19 blows: analyst

Suggested Articles

Former Indivior CEO Shaun Thaxter will face six months in federal prison for his role in misleading government officials on the dangers of Suboxone.

As of Friday after local time, 36 people have died in Korea after getting flu shots provided by at least seven companies, including Sanofi.

Two prominent pneumococcal vaccines from Merck and Pfizer are running low in Europe in a possible ill omen for the coming winter: report.