Heavy rains and flooding have forced India's Natco Pharma to temporarily suspend production at its API plant in Chennai.
The cessation of operations was disclosed in a stock exchange filing reported by Business Standard. The facility manufactures several oncology-related APIs, and the shutdown isn't expected to remain in place for long.
The rains are reported to be the heaviest in more than a century in the southern India state of Tamil Nadu. The flooding has forced thousands of people from their homes, closed plants and disrupted airport operations at Chennai, Reuters reported. The country's national weather office forecast at least three more days of torrential downpours.
"The company believes that this temporary shutdown should not impact/impair its pipeline launches associated with the plant," the company said in the filing. "The unit is also adequately insured for any losses it has incurred in fixed assets, raw materials and loss in production including work-in-progress."
Natco, along with several other large Indian drugmakers like Ranbaxy Laboratories, Wockhardt and Sun Pharmaceutical, has been battling back from FDA concerns about quality-control manufacturing issues raised by the U.S. regulatory agency two years ago. Natco received a Form 483 from the FDA for its finished dosage plant in Telangana in 2014.
Earlier this year, Natco won another battle in its efforts to knock down patent barriers to its generic drugs, specifically, for a version of the Gilead Sciences' ($GILD) influenza treatment Tamiflu (oseltamivir). In early March, the U.S. Supreme Court refused to accept Gilead's appeal of a lower-court ruling in favor of Natco.
Natco had teamed up with Alvogen in the U.S. to market the generic after the FDA gave it a tentative approval in 2014 to produce the drug. Gilead, which had licensed the drug to Roche ($RHHBY) for the U.S. market, sued to block the Natco generic.
- check out the Business Standard story