The US Food and Drug Administration (US FDA) has cleared Cipla Ltd’s manufacturing facility at Indore’s special economic zone (SEZ) of manufacturing practice violations that it had observed during an inspection in July-August 2015.
“Cipla has received Establishment Inspection Report (EIR) from the US FDA for its Indore facility indicating formal closure of US FDA inspection conducted in July/August 2015,” the company said in a stock exchange notice.
The company’s Goa units, however, came under the regulatory scanner on 30 September.
The US FDA clearance is a shot in the arm for Cipla as the company is trying to increase its footprint in the world’s biggest market for pharmaceutical products, where its penetration is significantly low. North America accounted for about 15% of Cipla’s total sales in 2015-16.
Following the inspection last year, the US drug regulator had issued a Form 483 to the company’s Indore plant with nine observations relating to deviations from good manufacturing practices.
The US FDA issues Form 483 to a facility if the inspectors observe conditions that violate the US Food, Drug & Cosmetic Act.
In a conference call with analysts post the June quarter results, Cipla’s management had indicated that abbreviated new drug applications filed from the Indore plant may not be significant as it was a relatively new manufacturing site.
The pharma company has not received product approvals in the US for those made in the Indore plant since the receipt of the Form 483.
Last month, the US FDA made four observations across Cipla’s three units in Goa after an inspection. The company said these observations were “procedural in nature” and that it had already responded to the regulator’s queries.