The Pune based Emcure Pharmaceutical Ltd, one of the leading players in the Indian pharmaceutical industry, is planning to offer a complete portfolio of bio pharmaceuticals, including growth hormones, gynaecological and infertility hormones, oncology and nephrology products in the near future.
Emcure is conducting researches to create a range of life saving recombinant human biogenerics. The company has world class R&D facility with segregated areas for mammalian and bacterial cell based research as well as upstream and downstream processing facilities.
The company has a team of experienced research scientists and technologists with expertise in rH gene technology, process optimization and downstream processing for biotechnology. The company's projects in pipeline focuses on nephrology, oncology, cardiovascular and gynaecology. The company's biogenerics in these areas is already in various stages of the regulatory process in India.
Emcure has a greenfield manufacturing facility for biotechnology at the Hinjewadi Biotechnology Park, Pune. The facility is designed as per the international standards and has facilities to develop recombinant products from the cell line upwards. The facility for small volume parenterals complements the biotech facility and provides the capability to fill formulations in pre-filled syringes, vials or ampoules.
The company has successfully developed and commercialized a set of novel drug delivery systems (NDDS), including instant mouth dissolve technology for instant release of drug ideally suited for NSAIDS and antihistamines. It has also developed chronotherapeutics tuned to the biological clock of the body for drug delivery at a desired time, such as the anti-asthmatic theophylline and colon specific drug delivery for targeted delivery of drug for ailments such as for amoebaisis using tinidazole.
The company is also active in APIs with focus on cardiovascular, haematinics and anti-retrovirals. The company's API division has identified and created chiral APIs, which deliver strong patient benefits. Emcure, pioneers in the chiral separation technologies, has launched chiral APIs as well as formulations such as S-Amlodipine and S-Atenolol in the domestic market. In addition, Emcure has launched Metpure XL, Panpure, Zordil and Tavin. The company is now in the process of expanding its basket of chiral APIs to emerge as a global leader in this niche area of activity.
The manufacturing facility at the Pune international park produces solid dosages (tablets and capsules) as per the current Good Manufacturing Practices (cGMP). The plant has an annual capacity of up to six to ten billion tablets/capsules.
The small volume parental facility with independent filling lines for pre-filled syringes, vials and ampoules was constructed at Hinjewadi Biotechnology Park in 2005. The facility is internationally complaint and is spread across an area of 20, 000 sqft. The facility, which has been audited and approved by UK MHRA and MCC South Africa, recently received the US FDA approval.
Apart, Emcure is a preferred outsourcing partner for some of the leading MNCs both in India and abroad. Emcure also researches, manufactures and markets formulations under its own brands in the domestic market and exports it to Asia, Africa, CIS, Europe, Latin America and the Middle East.
The company has entered into a number of strategic alliances with some of the best pharma companies for co-marketing, research, product development as well as contract manufacturing. Also, Emcure manufactures products and formulations on an ongoing basis for some of the leading pharmaceutical companies such as GSK, Novartis India Ltd, Pfizer India Ltd, Aventis Ltd and Proctor &Gamble Ltd.