User:Glochem
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Glochem Industries Ltd
Glochem Industries Ltd is Hyderabad-based, APIs (active pharmaceutical ingredients) and intermediates manufacturer. It have two manufacturing unit in AP (Bollaram and Vizag). Glochem Industries Ltd, with its strategic partner, CIMEX Pharma, Switzerland, is set to tap the regulated European and the US markets with its Clopidogrel Bisulphate, a heart drug, and Raloxifene, the osteoporosis drug. The Hyderabad-based, APIs (active pharmaceutical ingredients) and intermediates manufacturer, wants to launch the products in these markets soon. Cimex Pharma has already filed the DMF (drug master file) for Clopidogrel salt in Europe.
Blockbuster drugs
The APIs for the two blockbuster drugs are expected to bring in Rs 40 crore revenues to Glochem next year. While the originator for Clopidogrel, a blood dilutant, is Sanofi, Raloxifene originator is Eli Lily, said Mr K. Subba Rao, Managing Director.
The market for Clopidogrel in Europe is estimated at $2 billion and Glochem targets to capture 50 per cent. In US, the company is working with Cogentus and hopes to launch in two years, Mr Subba Rao told Business Line.
Glochem, which is the largest manufacturer of Amlodopine salts in the world, after the originator, Pfizer is planning to enter the formulation manufacturing with a 100 per cent export-oriented unit, in Visakhapatnam soon.
Cimex Pharma, the Schweizerhall Group company picked up 20 per cent equity for a consideration of $2 million in 2005 in Glochem. The money has been utilised to part fund the Rs 15 crore, 21,000 sq. m 100 per cent export-oriented API facility at Pharma City, Visakhapatnam.
USFDA approval
Glochem has its first production unit at Bollaram, Medak District near. It has recently got the USFDA approval for its products Amlodipine Besilate and Cetirizine dihcl, being manufactured here.
With patents for both these products in the US set to expire in September 2007 and January 2008 respectively, the company is betting big on boosting its revenues. This fiscal, Glochem hopes to log in Rs 35 crore turnover, grow to Rs 60 crore in 2008-09 and Rs 130 crore the next, Mr Subba Rao claimed.
The company is also focussing on Raloxifene, which is the next big opportunity, especially in the US. The osteoporosis drug which prevents depletion of calcium from the bones, has been launched by the company in Iran (one tonne per annum).
Product: - Active Pharmaceutical Ingredients
[edit] APIs
1. Amlodipine Besilate EP/BP – COS obtained from EDQM, USDMF being filed shortly.
2. Amlodipine Maleate- EDMF approved in EU countries.
3. Amlodipine Mesylate- DMF under preparation.
4. S (-) Amlodipine Besilate – DMF available in CTD format.
5. Cetirizine Di HCl EP/BP – COS obtained from EDQM, USDMF being filed shortly.
6. Raloxifene HCL – DMF available in CTD format.
7. Clopidogrel Bisulphate USP (form II) – DMF available in CTD format.
8. S (+) Ibuprofen – Technical package available.
9. S (-) Atenolol - Technical package available.
10. Ketoconazole – DMF under preparation.
11. Itraconazole
FOR MORE INFORMATION Glochem
