Glochem Industries Ltd, a Hyderabad based API manufacturer, announced the receipt of US FDA approval for its products Amlodipine Besilate and Cetirizine di HCl. The products are manufactured at its facility at Bollaram in Hyderabad. This approval gives Glochem access to highly regulated and lucrative markets like the USA. The product patent for two products Amlodipine Besilate and Cetirizine diHCl in the USA will expire in September 2007 and January 2008 respectively.
The company has already received the European GMP certification as well as the WHO GMP certification for its Bollaram facility. The company is also having the Certificate of Suitability for the same product from European Directorate for Quality of Medicines (EDQM). According to the company, the certificates have enabled Glochem to export APIs to all the 36 European countries including Germany, Italy, France, Switzerland, Spain, UK, etc. The company also has certifications, approvals, and registrations for its products in several other countries including Russia, Japan, Canada, Australia, Korea, South Africa, Ukraine, Tunisia, Mexico, etc.
Having achieved strong position in Europe, the company proposes to expand its market reach to the more markets in coming periods. "We are planning to file DMFs in Europe and the USA for its products namely Clopidogrel Bisulphate, Raloxifene HCl, Levo Cetirizine, S-Amlodipine and S+ Ibuprofen. The inspection of its facility at Pharma City in Vizag is expected by mid 2008 for the US FDA approval," K Subba Rao, MD of the company said.
The company is developing several APIs, eyeing a share in patent expiry period of some of the niche products in the coming period. Some of the products that are under development include Candesartan, Telmesartan, Eprosartan, Manidipine, Bernidipine, Nebivolol, etc.
With this the company aims to expand market reach and the extension of the product base by commercialising some of the products under development. The company is looking ahead to achieve compound annual growth rate (CAGR) of over 50 per cent for the next three years. The company will also explore to enter into some more strategic business alliances and partnerships to achieve much larger growth. "The business this year has been Rs 25 crore with 55 per cent exports. Considering the current outcome we are expecting a growth of 35 per cent this year," Rao said.
The company has a business association and share holding (equity) participation with a Swiss pharma company - Cimex Pharma, a Schweizerhall group company. Cimex has 20 per cent stake in the company.