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Japan's PMDA issues GMP certification to Lupin's unit-2 Mandideep facility
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New Delhi, Oct. 9 -- 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.
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