FDA Initiates Inspection Of Lupin New Plant In Indore

Lupin has reported that the FDA has started the inspection of its plant in Indore.

After the company receives the approval from FDA, it is expected to initiate the marketing of oral contraceptive (OC) drugs. These drugs are produced at the Indore plant and will be marketed in the US.

“The FDA during the week-long audit has not made observations (deviations from the American drug manufacturing standards). The audit should finish in a day or two,” an official reported.

He added, “We have been working with the FDA and would not like to comment on timing or any aspect of an impending audit. It would be speculative and prejudicial to do so.”

Reportedly last month, Nilesh Gupta, group president and executive director, said: “The company expects to earn between $100-200 million from sales of OC drugs in the US in the next few years. If the FDA finds deficiencies, the company will have address those, which could delay its US plans for OC drugs. The company expects to start selling OC drugs from next fiscal.”