why Product Recall

Headline Product Recall is Due to Non- Compliance With GMP by Third Party Manufacturer MJBP and Has Insignificant Value for Jubilant Source Press Release Company Jubilant Organosys Date July 02, 2009 Noida, India -- July 2, 2009 -- Jubilant Pharmaceuticals NV, Belgium, holds Market Authorisation(MA) for Amlodopine 5mg and 10mg in 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 MA 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 Aug 2008. The value of the product recalled is insignificant. During 2009, Jubilant has moved this product being manufactured by third party to its own UK MHRA approved facility at Roorkee in India. 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 Euro 1.7 Mn in FY 2009 and the sales of the product recalled is less than 10% of this. The Company’s global dosage forms business comprises less than 3% of its total revenues. The Company is committed to ensure the quality and efficacy of its products and maintains highest standards of compliance at all its manufacturing locations.

Source: EvaluatePharma®

©2009 EvaluatePharma Ltd

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