US FDA marks Lupin’s ‘sartans’ safe, but still issues one observation

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Gustavofrazao)
(Image: Getty/Gustavofrazao)

Related tags: Lupin Pharmaceuticals, India, Fda

The US FDA’s inspection of Lupin gave its manufacturing process for its ‘sartan’ products the all clear but managed to find one “procedural deficiency”.

Lupin Pharmaceuticals, the third largest Indian pharma company, issued a regulatory filing announcing that it had been inspected by the US Food and Drug Administration (FDA) between August 27 and August 31, 2018.

The inspection looked into Lupin’s current good manufacturing practices (cGMP), but also had another focus; the agency examined Lupin’s ‘sartan’ active pharmaceuticals ingredients (APIs), including valsartan, losartan, and irbesartan.

The decision to observe the manufacturing procedure of the sartan products occurred as issues have been found in the production of valsartan among certain Chinese companies​.

The FDA did not find any issues at Lupin’s facility in Tarapur, Indian. The company stated in a release​: “the US FDA concluded that the manufacturing processes of Lupin ‘sartans’ are safe with no chance of presence of the NDMA [N-Nitrosodimethylamine] impurity in the APIs.”

The occurrence of NDMA in a number of valsartan medications has led to numerous FDA notices regarding voluntary recalls​ by companies for products with contaminated APIs. NDMA is classified as a probable carcinogen by the WHO​.

Despite not finding any issues in the production of the sartans, the FDA did observe a procedural deficiency at the Tarapur site, which encompasses 14 manufacturing plants and five solvent recovery blocks.

Lupin did not reveal in its release what the observed procedural deficiency was in regards to nor the timeframe for rectifying the issue.

It’s not the first time that Lupin has faced issues with its India-based facilities. Lupin’s sites in Goa and Indore received warning letters at the end of last year due to GMP issues​.

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