The Hindu Business Line : Jubilant recalls hypertension drug from UK on regulator order

New Delhi, July 2 Jubilant Pharmaceuticals NV, a subsidiary of Jubilant Organosys, has recalled a generic drug used in the treatment of hypertension from the UK market.

This comes after the UK health regulator Medicines and Healthcare products Regulatory Agency (MHRA) ordered the company to the recall Amlodipine Besilate tablets due to serious deficiencies in Good Manufacturing Process found during an inspection of its contract manufacturer.

The regulator asked the company to recall the drug in 5 mg and 10 mg strength for which Wockhardt is the sole distributor in the country. The alert, which was issued on June 29 by the regulator, asked the company to recall the generic drugs from the UK market within 48 hours.

Jubilant Pharmaceuticals NV, Belgium, holds the market authorisation for the products in the UK, which was being manufactured at a third party location of MJ Bio Pharma (MJBP) India till last year.

“MJBP has failed EU-GMP audit by UKMHRA in June 2009 and subsequently all the market authorisation holders who have MJBP as their contract manufacturer have been asked by MHRA to recall the supplies made by them from the MJBP facility. Consequently, Jubilant has recalled its product: Amlodipine 5mg and 10 mg Tablets from the market. However, this recall pertains to the supplies made in August 2008. The value of the product recalled is insignificant,” Jubilant said in a statement.

During 2009, Jubilant has moved this product being manufactured by third party to its own UK MHRA-approved facility at Roorkee. The company is now supplying these products to its customers from this facility.

“Going forward this recall will not have any impact on the business. The company’s revenues from finished dosage form supplies in Europe were €1.7 million in FY 2009 and the sales of the product recalled is less than 10 per cent of this. The company’s global dosage forms business comprises less than 3 per cent of its total revenues,” Jubilant said.

The drug maker’s shares moved up 3.3 per cent to close at Rs 169 on the BSE on Thursday.

More Stories on : Regulatory Bodies & Rulings | Pharmaceuticals

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page