Lupin's Pune Facility Gets Five Observations After USFDA Inspection

The biotech facility has capabilities to manufacture mammalian and microbial products for commercial global supplies.

"Designed to develop and commercialise biosimilars global markets, Lupin Biotech conforms to ICH biosimilar guidelines issued by the U.S. FDA, EMA, WHO, PMDA and the Indian regulatory bodies," the company says.

The USFDA inspects and assesses regulated facilities to determine a firm's compliance with applicable laws and regulations. FDA investigators may observe conditions they deem to be objectionable during inspections. 

Inspected firms are encouraged to respond in writing, within 15 days from the issuance of the FDA- 483, FDA-4056, or verbal observations, by submitting their corrective action plan with supporting documentation, and promptly implement corrective actions to address the cited objectionable conditions.

Last week, Lupin said the USFDA issued six observations in its latest inspection at Pithampur facility. Three of the observations were made on Active Pharmaceutical Ingredients and on finished products.

In August, the company launched a generic cancer treatment drug Doxorubicin Hydrochloride Liposome Injection in single-dose vials in the US drug market.

The drug maker introduced the product after its alliance partner, ForDoz Pharma Corp., USA (ForDoz) received approval from the USFDA.

On Friday, shares of Lupin Ltd. closed 0.9% higher at Rs 2,205 on the National Stock Exchange.