India’s MJ Biopharma violates MHRA manufacturing norms; prompts 8 companies to withdraw generics in UK

Wockhardt, Jubilant are among those who recalled generics in UK fo sourcing from MJ Biopharm.

Indian contract manufacturing firm MJ Biopharm is under fire for alleged manufacturing violations after eight companies which sourced raw materials from MJ Bio were forced to recall their generic drugs in UK.

MJ Biopharma was allegedly found violating good manufacturing practices norms following an inspection on the the Indian drug maker’s plant by the British druf watchdog  the Medical and Healthcare Products Regulatory Agency (MHRA)

The violations in the manufacturing process prompted MHRA ordering withdrawal of several drugs manufactured in the facility.

The production methods for generic drugs sold in the UK, including a version of the anti-depressant Prozac made by Swiss giant Novartis, failed the minimum standards set by the European Union, reports said.

Sandoz,Novartis’s generics unit,  was one of about eight companies that recalled drugs because of alleged  deficiencies in good manufacturing practices found during inspections of the contract manufacturer, MJ Biopharm, in India.

Sandoz also recalled the diabetes remedy metformin, and baclofen, for muscle spasms.

“These were not major products, and we had already discontinued marketing them,” Sandoz spokesman Chris Lewis was quoted as saying. She also added that Sandoz did not get any other products from MJ Biopharm.

Indian companies such as Wockhardt U.K., Jubilant Pharmaceuticals are among other companies  that withdrew drugs from UK market.

Jubilant recalled amlodipine, the copycat form of calcium channel blocker Norvasc.

Jubilant Organosys, the Indian parent to the Belgian firm affected by the recall, said it has already taken that manufacturing back in-house, to its own regulator-approved plant in India.

Other clients of MJ Biopharm who withdrew drugs promptly from the UK market includes Stranhaven, LPC Medical, Karib Kemi Pharm, Milipharm and Greystone.

MHRA’s inspectors found “inaccuracies contained in documents such as batch manufacturing and testing records”. However MHRA maintained that, “at present, there is no specific evidence to suggest that the medicines are not safe for patient use”.

Other drugs involved in the recall included hypertension pills, diabetes medicine and pain-relieving drugs.

Generic drugs make up more than a fifth of the UK’s pharmaceuticals market, including supplying 22% of NHS-dispensed medicines.

MJ Biopharm is primarily engaged in exports and export-oriented production of Pharmaceuticals, Agrochemicals, Aromatic chemicals and Perfumery compounds With offices and manufacturing facilities spread across the world, the group essentially operates as a coordinated cluster of divisions, which in reality are companies.

MJ Biopharm has association with well-known International groups for manufacturing their human insulin range of products.

MJ Biopharm’s  biotechnology initiatives are focused on development of biology, the innovative “bio-pharmaceuticals”. With excellent facilities and expertise of human recombinant DNA human insulin Formulations, the efforts are to develop ”Key Knowledge” based on Biological Entities, leading to manufacture and market of high value bio-therapeutics with global benchmarks.

MJ group is primarily engaged in exports and export-oriented production of Pharmaceuticals, Agrochemicals, Aromatic chemicals and Perfumery compounds With offices and manufacturing facilities spread across the world, the group essentially operates as a coordinated cluster of divisions, which in reality are companies.

MJ Biopharma’s manufacturing facility at is a state-of-the-art facility conceived & designed in consultation with Eli Lilly Service Support Group. Spread over more than 25,000 sq.m. area. Comprised of three separate buildings

Dedicated set-up for cephalosporins & dry powder injectables to avoid cross-contamination. The plant has capacities for 50 million ampoules;8 million vials;300 million tablets;50 million ampoules and over 10 million cephalosporin dry power injectables.

MJ Biopharma has strategic alliances with Diosynth B.V.of the Netherland belonging to Akzo-Nobel group, supplies insulin crystal on specific market exclusivity basis;Bioton of Poland witha manufacturing base in Warshaw to manufacture both insulin crystal as well as insulin vial and cartridges. Bioton also have a strategic alliance with Akzo-Nobel and supplies insulin crystal to MJ on specific market exclusivity basis.Bioton also manufacture Biosulin brand of insulin vials and cartridges for Marvel Life Sciences, UK, a company belongs to MJ Group.

MJ Biopharma has product development & marketing activities for Euro market with PSI – Belgium and with Sanofi Aventis for specific strategies, product development & marketing.