Glochem Industries Limited, a Hyderabad-based manufacturer of active pharmaceutical ingredients (APIs) and intermediates, has received approval from the US FDA for two products "" Amlodipine Besilate and Cetirizine DIHCL "" being manufactured at its Bollaram facility on the city outskirts. | |
| The receipt of the FDA approval is strategically timed since the patents for the two products in the US are expiring in September 2007 and January 2008 respectively, Glochem stated in a press release. |
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| "Having achieved a strong position in Europe already, the company will now be expanding its market reach to the more lucrative US market, and will soon be filing the drug master files (DMFs) for some more products including Clopidogrel Bisulphate, Raloxifene HCL, Levo Cetrizine, S Amlodipine and S+ Ibuprofen in Europe and the US. The company also expects the inspection of its 100 per cent export-oriented facility at the Pharmacity in Visakhapatnam by mid 2008, so that it can have the FDA approval for the facility as well at the earliest," the release added. |
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| The company is currently working on the development of several other APIs at its R&D facilities in Hyderabad and Visakhapatnam. |
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