The Hyderabad-based Glochem Industries Ltd, a manufacturer of APIs and drug intermediates primarily focusing on European markets, is upgrading its facilities to meet European regulatory standards. A number of big generic companies in Europe and some companies in the US have already shown interest in Glochem's products, K Subbarao, chief promoter and managing director of Glochem told Pharmabiz.
The company has recently upgraded its R &D centre at Hyderabad in order to develop non-infringing processes and has tied up with the Indian Institute of Chemical Technology (IICT), Hyderabad which is offering its expertise and advisory services to the company on the technology front.
Revealing the developments at Glochem, Subbarao said, the company is ready with DMFs with US FDA. It has filed DMFs of Amlodipine (to get off-patented in 2006), Ceterizine (to get off patented in 2007), Raloxifene (to get off patented in 2007) and Clopidogrel (to get off patented in 2007).
The company will be taking up the manufacture of two bulk drugs, namely Candesartan and Ketaconazole at its facility near Hyderabad by February 2005. Candesartan is a cardiac drug (patent is held by a Japanese company) and the Ketaconazole is antifungal (off-patented drug).
The company is primarily looking at catering to customer requirements, life of Patents and chemistry capabilities to manufacture certain APIs. It has a WHO-GMP approved facility at Bollaram near Hyderabad and has another facility at Bonthapally, which is taken on lease. The Bollaram facility is manufacturing most of the company's APIs whereas the Bonthapally unit is used for manufacture of intermediates and to carry out contract manufacturing.
The company is offering contract manufacturing services to medium-scale pharmaceutical players such as Hetero Drugs, SMS Pharma and Lee Pharma in Hyderabad. The Bonthapally unit was taken on lease during early 2004 and major portion of contract manufacturing has been carried out in this facility.
As of now, contract manufacturing activity forms constitutes about 15 per cent of the company's overall activity. The company has started contract manufacturing in its Bollaram unit about six years ago and at that time has offered services even to Dr Reddy's Laboratories. The company's focus has gradually shifted from contract manufacturing to manufacture of APIs over the years, Subbarao added.
The company has also taken up custom synthesis in the past. Candesartan is to be manufactured as part of this effort. Candesartan has lots of potential in markets such as Brazil, Pakistan and many parts of Africa. Candesartan was invented before 1995.
On Glochem's other future initiatives, he informed, the company is planning to invest about Rs 3-4 crore for setting up a manufacturing and R &D facilities at the Jawaharlal Nehru Pharma City developed by Ramky at Parawada near Visakhapatnam (AP).
Glochem is keen on tapping opportunities in the regulatory markets, new product launches, entering partnerships with existing customers in meeting their product requirements and contract manufacturing in the next 2-3 years, he added.
The company is expecting a total turnover of Rs 18 crore this financial year, of which exports will account to about 35-40 per cent. By 2007, the exports of the company will contribute equally to the total turnover as in case with domestic business, he said.
The company has been exporting its products to the US, UK, Denmark, Germany, Mexico, Brazil, Spain, China, Korea, Iran, Pakistan, Singapore, Taiwan, Turkey and UAE besides other countries. Glochem has completed eight years of its operation.