IBPL Becomes Country's First Dedicated Biopharmaceutical Facility to Receive EU-GMP Certification

Intas Biopharmaceuticals Limited has achieved a unique distinction to become India’s first dedicated biopharmaceutical company to receive certification of European Agency for the Evaluation of Medicinal Products or an EU-GMP certification for its manufacturing facility at Ahmedabad, Gujarat.

MUMBAI, India | June 12, 2007 |
Intas Biopharmaceuticals Limited (IBPL) has achieved a unique distinction to become India’s first dedicated biopharmaceutical company to receive certification of European Agency for the Evaluation of Medicinal Products (EMEA) or an EU-GMP certification for its manufacturing facility at Ahmedabad, Gujarat. The certification is a significant step towards fulfilment of IBPL’s plans to tap Europe market. Moreover the certification give strong advantage to IBPL as the company can strengthen existing alliances and look forward to possible agreements with other pharma/biotech companies in new geographical regions of Europe.

Addressing the media, Shri Mani Iyer, Director, IBPL, said, “On the Research & Development (R&D) front, the certification will allow IBPL to get an entry into regulated markets of Europe to conduct clinical trials for many of our products which are in the pipeline. The process of clinical trials is mandatory and a pre-requisite for the company to develop the products and market them in Europe. Additionally, this certification has opened new avenues for the company to explore existing/new technologies and processes.

For IBPL, EU-GMP certification will also simplify the procedure for product registration in different countries of the world by significantly reducing the time required by the company to get the product registration. Also, many companies across the globe would be keen to associate with us for our products and services.”

The company has successfully launched therapeutic recombinant proteins Neukine (rHu G-CSF), Erykine & Epofit (rHu EPO) and Intalfa (rHu IFN Alfa-2b) in the domestic markets and couple of international markets. It is the only company in the state of Gujarat with an impressive track record of launching three indigenously developed biotech products in as many years.

Elaborating on the company’s marketing plans, Shri R. Chandrashekhar, Sr. Vice President (Global marketing and Business Development), IBPL, said, “With new products in the pipeline and planned efforts to launch these products on domestic and international front, the certification will give IBPL a significant boost to our efforts in registering and commercializing our products in many regulated markets.

Starting with bio-generics, IBPL has structured its progression to the development of proprietary and innovative recombinant biopharmaceuticals. IBPL has also entered into several distribution and marketing agreements with reputed international companies in regulated and semi-regulated markets of Europe, Asia-Pacific, Middle East, Russia & CIS, South and Central America and Africa. On the domestic front, IBPL will have strong advantage as the certification is indicative of superior quality standards in line with international guidelines and procedures. IBPL will find itself in the best position to plan certain key initiatives in the coming financial year.”

About Intas Biopharmaceuticals Limited
IBPL has fully integrated biopharmaceutical operations at Ahmedabad, Gujarat. Since the launch of biotechnology operations in May 2000, R&D and manufacturing of biopharmaceutical products with a special focus on Oncology (Cancer) are major thrust areas for the company. The company’s physical infrastructure includes world-class R&D laboratories, manufacturing unit, QA/QC wing and administrative operations. The manufacturing facility is well equipped for production of fermentation as well as cell culture derived bulk drugs and finished products in pre-filled syringes and vials. The QA/QC department have one of the finest infrastructures in the country and has Quality Management System to emphasize on strict compliance of international guidelines for the processes.

Indus Biotherapeutics is a dedicated biopharmaceutical Contract Research Organization. This company solely concentrates on research and development of novel targets as well as bio-generics. Indus’ expertise lies in process and product development, analytical method development, bio-chemical immunological analysis, process validation, scale-up and technology transfer to manufacturing scale.

Celestial Biologicals focuses on the manufacturing and marketing of plasma derived products mainly Albumin, Immunoglobulin, and Coagulation Factors (Factors VII, VIII, IX, XI, and Fibrinogen). Celestial Biologicals plans to invest heavily in creating south Asia’s largest plasma fractionation facility. The facility would cater to Indian requirements and the needs of other SAARC countries.

SOURCE: Intas Biopharmaceuticals Ltd.

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