USFDA clears Cipla's facilities
NEW DELHI: Cipla has successfully addressed all the nine manufacturing deficiencies pointed out by the US Food and Drug Administration (FDA) at its Bangalore manufacturing plant. The company received an official communication about the approval from the USFDA about a month back, a senior company executive said.
In April this year, the FDA issued form FDA 483s — an inspection re-port pointing out deviations from US manufacturing standards — and listed nine deficiencies.
The Mumbai-based company had then said the deviations, which include one relating to data entry, ‘were of routine minor nature, suggesting need for improvements in good manufacturing practices’. Cipla also submitted a response within the next 30 days. When contacted, Cipla’s chairman and MD YK Hamied said all its plants are routinely inspected and are currently approved by the US drug regulator. But, he declined to comment on whether the company received any intimation from FDA, after it submitted its response to the drug regulator to correct the deviations at its Bangalore plant.
Ranjit Kapadia, Institutional Research (VP) and pharma analyst at HDFC Securities said in a note issued last week, “Cipla has been able to respond to the nine observations raised by the USFDA and has come out clean.” Mr Kapadia said if the FDA does not raise further questions within the next few months, it is assumed the company’s response is satisfactory. FDA periodically inspects all plants approved by it 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 among the list of the few Indian pharma companies besides Ranbaxy, Lupin and Sun Pharma’s US arm Caraco Pharmaceuticals, who have been pulled up by the USFDA for not adhering to the US manufacturing standards in recent times.
If Cipla had failed to resolve any of the nine deviations, FDA could have issued a warning letter and halted approval of new drug applications from the facility.
While the FDA has banned some drugs of Ranbaxy, it seized 33 drugs made by Caraco Pharmaceuticals at its Michigan facility. Mumbai-based Lupin had also received a warning letter in May this year after it failed to address some of the deficiencies FDA noted in an inspection last year.
Although, Cipla’s problem is not as serious as its counterparts, as FDA merely pointed out manufacturing deficiencies, it is the only Indian company in recent times to address the non-compliance issues and get a clean chit from the FDA. Cipla’s US sales are small accounting for about 10% of its total sales of Rs 5,000 crore and it has four plants in India which supplies drugs to the US.
September 08, 2009