MJ Biopharm GMP breach prompts number of recalls

By Gareth Macdonald

- Last updated on GMT

Related tags Pharmacology

Novartis and Jubilant Organosys are among several companies forced to recall generic drugs after manufacturing operations at their shared CMO, India’s MJ Biopharm, were found to be in breach of GMP guidelines.

A UK Medicines and Healthcare products Regulatory Agency (MHRA) inspection at MJ’s facility in Mumbai last month revealed several “serious” deficiencies from good manufacturing practice (GMP) standards.

While the MHRA said that it has discovered a number of inaccuracies in batch manufacture and testing records, but stress that, at present, no drug safety issues have emerged.

While MJ has yet to issue a response to the inspection its contract manufacturing clients have been quick to address the problem with several, including Stranhaven, LPC Medical, Karib Kemi Pharm, Milipharm and Greystone, initiating recalls.

Sandoz, the generics unit of Swiss drug major Novartis, is one of the highest profile companies affected. MJ produced the firm’s version of the antidepressant floxetine and the muscle agent baclofen and the diabetes drug metformin.

Company spokesman Chris Lewis told the Wall Street Journal​ that the recalled drugs “were not major products​,” adding that the firm had already discontinued marketing the medications in question some time ago.

Jubilant Organosys was the other high profile casualty and was forced to withdraw 5mg and 10mg non-branded formulations of the anti-hypertension treatment amlodipine from UK shelves.

The recall, which was enacted by the firm’s Belgian Jubilant Pharmaceutical unit, also impacted Wockhardt, which was responsible for distribution of the drug in the UK.

Jubilant told Reuters​ that: “This recall pertains to the supplies made from ... MJBP in 2008​,” and added that: “The value of the products recalled is insignificant to the overall turnover of Jubilant.”

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