BackJapan's PMDA issues GMP certification to Lupin's unit-2 Mandideep facility
GMP certificate was issued following an inspection that closed with no critical or major observationsThe certificate is valid till September 2024
PremiumNew Delhi: Lupin has received a good manufacturing practice (GMP) certificate from Japan's Pharmaceutical and Medical Devices Agency (PMDA) for its bulk drug manufacturing facility at Mandideep in Madhya Pradesh, the company said in an exchange filing.
PMDA's inspection of Mandideep Unit II from May 14-17, 2019 ended with no major or critical observations, following which the certificate was issued, Lupin said. The certificate is valid till September 2024.
Lupin's unit-2 at Mandideep manufactures cardiovascular 'pril' active pharmaceutical ingredients (API).
The Japanese regulator's approval for unit-2 comes less than a month after the US Food and Drug Administration issued a warning letter for the adjoining unit-1.
In the warning letter for unit-1, the US FDA found violations of GMP norms which were similar to those at two other plants of the company--Pithampur in Madhya Pradesh and Goa, prompting the regulator to call out the possibility of company wide issues of violations.
News of PMDA's approval, however, may have steadied nerves, which was reflected in positive investor sentiment for Lupin's stock today. The stock closed 2.3% higher at ₹683.1 on the National Stock Exchange.
Lupin is the fifth largest generic pharmaceutical player in Japan, and the third largest Indian pharmaceutical company by global revenues, as per the filing.
For 2018-19 (Apr-Mar), Lupin’s consolidated sales and net profits were at ₹16,370 crore and ₹950 crore respectively.
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