FDA slaps import alert on India's Shilpa after sterile injectables issues multiply

Just a few months after India-based drugmaker Shilpa Medicare found itself in the FDA's crosshairs, the company now faces a ban on the vast majority of its products in the U.S. 

The FDA slapped an import alert on Shilpa Medicare's formulation plant in Telangana, India, according to a notice posted Thursday. The product ban comes on the heels of an FDA warning letter that cited the Indian drugmaker for multiple manufacturing violations. 

The FDA spared three Shilpa drugs in its alert: injectable azacitidine—used to treat myelodysplastic syndrome—plus cyclophosphamide capsules and erlotinib tablets, all of which are chemotherapies for cancer. Those drugs just so happen to account for the bulk of Shilpa's sales, too, Express Pharma reports. Meanwhile, injectable azacitidine has also found its way onto the FDA's drug shortage. 

The import alert applies solely to Shilpa's finished drug manufacturing plant at the Telangana State Industrial Infrastructure Corporation's pharma-focused special economics zone. Aside from that factory, Shilpa also operates two FDA-approved API plants in Raichur, India. 

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The alert could blunt the upward trajectory of Shilpa's formulation business, which grew 40% between 2019 and 2020, according to the company's annual report. The Talangana site is the only Shilpa facility currently under FDA scrutiny, the company said in October, according to The Hindu Business Line.

Shilpa didn't immediately respond to Fierce Pharma's request for comment. 

The Telangana plant fell afoul of the FDA last year after it failed to address complaints about a 2019 batch of improperly sealed injectable drugs. Shilpa admitted the errors were tied to a "breakdown of the sealing machine," but released batches onto the market anyway, failing to notify the FDA in the process. 

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The company pledged to inspect its equipment after it was hit with a Form 483 in March 2020, but those efforts weren't enough, the FDA said in its October warning letter.

"You provide no justification for having released the batch ... including the portion filled during the first hour of sealing, when a machine breakdown occurred," investigators wrote. 

That wasn't Shilpa's only slight, either. The company received multiple customer complaints about particulates turning up in its drugs, but blamed the problem on user error, the FDA said. It also failed to notify the regulator about the complaints. 

The drugmaker also neglected to properly investigate possible contamination after its own testing turned up problems with its meds.