Apotex recalls Ao-Amilzide, Apo-Meloxicam and Apo-Ranitidine lots from Canada

Canada’s largest drug maker Apotex Inc has recalled certain lots of Apo-Amilzide 5-50 mg, Apo-Meloxicam 7.5 mg and 15 mg, and Apo-Ranitidine 75 mg and 150 mg from the market, following Health Canada inspections on the manufacturing facilities in Toronto.

Apotex’ recalled drugs Apo-Meloxicam is indicated for treatment of symptoms of rheumatoid arthritis and osteoarthritis in adults. Apo-Ranitidine is indicated for treatment and prevention of problems associated with excess stomach acid, while Apo-Amizide is prescribed for the maintenance therapy of patients with liver cirrhosis with fluid in the abdomen and swelling.

Inspection in Apotex Toronto facilities is part of Canada’s health regulator Health Canada’s ongoing inspections of Apotex manufacturing facilities in the Greater Toronto Area. Health Canada is also working with Apotex to undertake a thorough review of their Good Manufacturing Practices.
Health Canada would continue inspections of Apotex facilities in Ontario in coming weeks to determine if other products are also affected and whether manufacturing standards are being followed, the Canadian regulator said.

Meanwhile, Apotex sources denied that there was any problems with the safety or efficacy of the recalled lots of Apo-Amilzide, Apo-Meloxicam and Apo-Ranitidine. Recall of the products is voluntary and precautionary.

Good Manufacturing Practices (GMPs) are standards designed to ensure an effective overall approach to product quality control and risk management. GMPs do so by setting appropriate standards and practices for product manufacturing, testing, storage, handling and distribution, a Health Canada announcement regarding the Apotex inspection said.

Apotex had received a warning letter from the U.S. Food and Drug Administration in June following several violations of manufacturing procedures standards set by the agency at the Toronto facilities.
US FDA charged that Apotex failed to investigate thoroughly the failure of batches of some drugs and also noted an unusually high number of rejected batches manufactured in the Toronto facility.

US FDA warned Apotex that if the company failed to correct a number of manufacturing breaches the FDA could freeze new drug applications in the United states and ban Apotex products from entering US territory.

Apotex Corp. is the largest Canadian-owned manufacturer of prescription drugs. Apotex has marketing headquarters in Weston, Florida and operations center in Indianapolis. Products manufactured by Apotex Inc. and marketed by the Apotex Group are sold in 115 countries around the world.

Apotex produces more than 300 generic molecules in a variety of different presentations, which, in Canada, are used to fill over 80 million prescriptions a year – the largest amount of any pharmaceutical company in this country.

In India Apotex operates through Apotex`Research Pvt. Ltd, is a wholly owned subsidiary of Apotex Inc. at Bangalore, which has an R&D Centre, manufacturing and a bioequivalence Centre.

In February, Apotex Inc and Ahmedabad-based Intas Biopharmaceuticals Limited of India extended their business agreement to develop a biosimilar version of pegfilgrastim, a protein that is used to treat neutropenia, Neupeg. This collaboration gives Apotex the rights to market the product in North America (US and Canada), Europe and selected other countries.

Similarly, Chennai, South Indian pharma firm Orchid Chemicals and Pharmaceuticals Ltd also have a supply and marketing agreement with the US based Apotex Corporation for the sale of Orchid’s generic cephalosporin and other injectable products in the US.

Under the agreement, Orchid will undertake development, manufacturing and supply of these products while Apotex will handle all sales and marketing efforts in the US.