The Hyderabad-based Lee Pharma (P) Ltd is planning to upgrade its bulk pellets facility located at Kukatpally in Hyderabad from the current 30 tonne per month capacity to 100 tonne per month. The company is also expecting WHO GMP approval for this facility in next three months. Its API facility based at Jinnaram in Medak District has been recently accorded ISO 9001:2000 certification by NQA of UK, A Venkata Reddy, managing director of the company told Pharmabiz.
The company produces APIs in various therapeutic segments such as antiulceratives, antifungals, antidepressants, antipsychotics, and anti inflammatory drugs. During the last year, the company's API facility has been approved by the WHO GMP authorities for manufacture of Itraconazole and Lansoprazole powder.
The company which is constructing exclusive pharma blocks is also hoping to obtain USFDA approval and other international accreditations to enter into regulated markets, he added.
He informed, the company was initiating several measures to explore and develop new molecules with the help of its research and development centre, recognized by Ministry of Science and Technology.
It has filed DMFs for five products in CTD format in Europe and few more products are being compiled to be filed as DMFs. The company which had a turnover of Rs 25 crore in the last financial year is aiming at reaching Rs 40 crore this fiscal.
The company is targeting at international markets including Europe, Latin America (Brazil and Mexico), South-East Asian Countries (Korea, Pakistan and Bangladesh). In the domestic market, the company is serving pharma giants such as DRL, Cipla, Cadila and Matrix.
Reddy says, post 2005, there are good opportunities for companies who have right systems in place and who respect regulatory compliance. The companies having quality manufacturing facilities will have abundant opportunities in contract manufacturing as the global companies are on look out for outsourcing hubs. India has good technical expertise and implementation systems in place to its credit. As the Indian companies produce quality drugs and meet specifications as guided in various pharmacopeia there is going to be a boom in API and intermediates sector in the country.
Majority of Indian pharma players have already set their eyes on entering global regulated markets with generic products. All the developed countries in the world are now looking at countries like India for cost effective drugs to reduce the socio-economics burden that the countries are facing due to increasing population of aged people. Factors like these are favouring India to have an industry growth rate of 20-25 per cent in the coming years, he added.
On the other hand, the pharma companies are fighting among themselves within the industry, in an unregulated environment, by cutting prices, crashing markets and closing the opportunities of one another, which needs to be changed, he opined.