The United States Food and Drug Administration (USFDA) has completed cGMP inspection at Lupin’s Tarapur API Manufacturing Facility. The inspection closed with one observation, a procedural deficiency. The inspection at the site was conducted during August 27-31, 2018 by three FDA investigators.
The inspection focused on cGMP compliance and also on the safety of Lupin’s Valsartan, Losartan and Irbesartan APIs (commonly known as ‘Sartans’) in light of the safety alert issued by Regulatory Authorities on the NDMA (classified as a probable human carcinogen) impurity in Valsartan API supplied by some companies. During the inspection, the USFDA concluded that the manufacturing processes of Lupin ‘Sartans’ are safe with no chance of presence of the NDMA impurity in the APIs.
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1675.20 |
| Dr. Reddys Lab | 1235.40 |
| Cipla | 1238.30 |
| Zydus Lifesciences | 942.55 |
| Lupin | 2324.25 |
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