Panacea Biotec on Friday said it has received Establishment Inspection Report (EIR) from US FDA for its Baddi formulation facility in Himachal Pradesh, indicating a formal closure of the inspection.
Panacea’s Baddi facility manufactures anti-cancer injectables and oral solid dosage formulations.
The facility is critical for Panacea’s generics business in the United States as the company filed numerous abbreviated new drug applications (ANDAs) from the site. These include already-approved products and products under various stages of getting approved by the US FDA.
The release of EIR notification by USFDA indicating inspection is “closed” means, the USFDA has concluded review of the Company’s manufacturing activities and the company is allowed to continue supply of all the approved drug products by USFDA into inter-state commerce,” Panacea said in a statement.
“The EIR notification also accelerates approval process for submitted drug product applications,” it added.
The company's oral solids manufacturing facility located at Baddi has completed 5 consecutive successful current good manufacturing practices (cGMP) and pre-approval inspections by the US FDA over the last 8 years. Its Oncology Parenteral Formulations facility has successfully cleared two inspections by the agency.
“We remain committed to continue to manufacture and supply quality products to cater to patients’ needs across several markets including USA,” said Rajesh Jain, Joint Managing Director of Panacea.
The company has been trying to expand its international exports business, particularly to the US, to diversify from over reliance on the global tender market for vaccines, which can be lumpy and highly competitive.
The company is also struggling on account of the delays in the servicing of its external debt, due to cash flow challenges, Care Ratings said in December. The rating agency downgraded the credit rating for the company's long-term bank facilities of Rs 959.55 crore, and short term bank facilities of Rs 61.97 crore.
During FY17, Panacea has expanded its existing collaboration with US-based Bionpharma for marketing of its two ANDAs. The company launched Rizatriptan oral dispersible tablets, used in treatment of migraine, in the US market through such a strategic collaboration.
The company also launched Prasugrel tablets with 180-day exclusivity in the US, in a distribution partnership with Canadian drug maker Apotex.
Panacea is now working on more than 10 ANDAs that are expected to be filed over the next 2 years. The company plans to launch these products in US, Europe, and other markets through strategic collaborations with leading pharma companies.