India’s top generic maker Cipla’s pharmaceuticals manufacturing facility in Bangalore has been cleared of alleged violations in current good manufacturing practices (cGMP) norms by US FDA.
USFDA officials had issued warning notices to the Mumbai-based Cipla for deficiencies in manufacturing practices following their inspection in its Bangalore facility.
USFDA inspection team has reportedly found out a few violations in the manufacturing norms mandated by the agency. Subsequently, USFDA asked Cipla to submit report on the corrective measures within 30 days of serving the warning notice, in April.
Cipla has addressed all the manufacturing deficiencies pointed out by the USFDA and submitted a report within the time-frame as required by FDA 483s. Following this, Cipla received an official communication about the approval from the USFDA about a month back, it is learnt.
USFDA periodically inspects all plants approved by the agency to ensure that drugs made at these facilities are safe to be sold in the US. For plants in India, the FDA usually makes a biannual inspection.
Cipla is currently the top generic company in India. Cipla also exports APIs and formulations to several regulated and semi-regulated markets including US, UK and South Africa.
In May, Cipla received approvals from USFDA for tenofovir disoproxil fumarate tablets. The drug is used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Cipla is allowed to sell the drug in tablet form in dosages of 300 milligram under the President’s Emergency Plan for AIDS Relief program.
Tenofovir disoproxil fumarate tablets are the generic version of Gilead Sciences Inc.’s (GILD) Truvada.
Similarly, Cipla received approvals for stavudine and levetiracetam from the United States Food and Drug Administration (USFDA), in March.
USFDA’s action against Cipla is the latest in a series of inspections and warning letters issued by the regulator against Indian drug makers.
Last year, FDA had banned 30 Ranbaxy form selling 30 drugs, which are manufactured at two of its plants in India, as one such inspections found a number irregularities in good manufacturing practice norms.
US FDA also made raids and stock seizure at the Detroit facility of Caraco Pharmaceutical, Sun Pharma’s American subsidiary, and has also halted approval of new drug applications from this plant severely impacting the company’s revenues.
In November, the agency found 15 manufacturing deficiencies at Lupin’s plant in Madhya Pradesh.