Japan's PMDA issues GMP certificate to Lupin's unit at Mandideep facility

Pharma major Lupin Ltd on Wednesday announced the receipt of good manufacturing practice (GMP) certificate from the Pharmaceutical and Medical Devices Agency (PMDA) of Japan for its active pharmaceutical ingredient facility at Mandideep in Madhya Pradesh.

The GMP certificate was issued following an inspection conducted by PMDA between May 14 and 17. The PMDA inspection closed with no critical or major observations, said the pharma major in a statement.

"The GMP certificate issued by PMDA for Mandideep facility (unit two) is valid till September 2024," it added.

About three weeks ago, The US Food and Drug Administration (US FDA) had issued a warning letter to Lupin Ltd for the same facility's unit one. Earlier in March, the US FDA had classified its inspection conducted at the same facility in December last year as 'official action indicated.'

Investment information consultancy ICRA recently said that continued regulatory overhang with respect to manufacturing quality deficiencies highlighted during US FDA audits remains a key concern for the Indian pharmaceutical industry.

Lupin is the eighth largest generics pharmaceutical company by revenues globally. In the financial year 2018-19, it reported a net profit of Rs 606 crore with total revenue from operations on a consolidated basis at Rs 16,718 crore.

The company's 18 manufacturing facilities are spread across India, Japan, the United States, Mexico and Brazil.