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GMP violations at Indian CMO hit UK generics makers

Published on 08/07/09 at 07:59am

Eight manufacturers of generic medicines in the UK have been forced to withdraw batches of product from the market because of problems at a contract manufacturing organisation (CMO) in India.

Serious deviations from good manufacturing practice (GMP) were uncovered during an inspection of MJ Biopharm's facility in Taloja, Navi Mumbai, last month by the UK regulator the MHRA.

The findings prompted a Class 2 recall, which requires action within 48 hours of notification. All marketing authorisation holders who have cited MJ Biopharma as their contract manufacturer have been asked by the MHRA to recall supplies.

"At present there is no specific evidence to suggest that the medicines are not safe for patient use," said the agency. All unexpired stock of the affected products should be quarantined and returned for credit, it added.

Novartis' generics subsidiary Sandoz has been forced to recall four products, namely 20mg capsules of the antidepressant fluoxetine, a 10mg tablet formulation of baclofen for spasticity, and 500mg and 850mg strength tablets of the oral diabetes medication metformin.

LPC Medical (UK) has had to pull metformin 500mg and 850mg tablets, co-amilozide 5/50 tablets for hypertension and oedema, and 250mg and 500mg tablets of the non-steroidal anti-inflammatory drug naproxen.

Karib Kemi Pharm has recalled 20mg fluoxetine capsules and 2mg and 4mg tablet formulations of the antihypertensive drug doxazosin, and Milpharm has recalled its fluoxetine product.

Also affected were 5mg and 10mg tablet formulations of the calcium channel blocker amlodipine besilate sold by Strandhaven, Greystone and Jubilant Pharmaceuticals, the Belgian subsidiary of Indian contract research and manufacturing services company Jubilant Organosys.

Wockhardt is also cited by the MHRA in the recall notice, as it was a distributor for Jubilant's amlodipine products in the UK.

In a statement Jubilant said the recall only affected batches made in 2008 and that, earlier this year, it had transferred production of the affected products to its own manufacturing facility at Roorkee in India. The value of the recalled product is "insignificant," added the firm.

Sandoz also downplayed the situation, saying that it had already removed the affected products from the market and does not currently contract MJ Bipharm to make any of its other lines.

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