- Injectable lines already approved by all major regulatory agencies
- 2 oral products for Europe to be commercialized in Q3 ‘11
Onco Therapies Limited (OTL), a division of Agila (a wholly owned subsidiary of Strides Arcolab Limited, ‘Strides’) today announced that it has received European approval for its Oral Dosage Oncology facility (tablet and hard gelatine capsules) in Bangalore.
The Injectable facility within the Oncology complex has already been approved by all major regulatory agencies.
The facility is now amongst a few European approved Oral dosage oncology plants worldwide.
The Company expects to commercialise 2 products in Europe during Q3 2011.
Commenting on this development, Venkat Iyer, CEO, Agila Specialties, said, “We are delighted with this development as this further consolidates our global strategy of emerging as a leading provider of oncology drugs. The approval is also a testimony to the high standards of quality, compliance and containment practices put in place by Strides”.
The state-of-the-art Oncology complex which was established in 2009 manufactures injectables, oral products (tablets and softgels) in the oncology domain. It has been built to the most exacting standards, meeting the requirements of regulatory authorities in the most stringent global markets and is already approved by all other major regulatory authorities allowing the Company to sell globally.
About Agila Specialties
Agila is the specialties unit of Strides Arcolab which was spun off as a separate division post the Company’s restructuring in 2009. It is focused on key domains such as oncolytics, penems, pencillins, cephalosporins, ophthalmics, peptides and biosimilars and operates from 8 world class global manufacturing facilities, including one of the largest steriles capacity in India and amongst the largest lyophilization (freeze drying) capacities in the world. Agila’s marketing network covers 70 countries and it has partnerships with some of the world’s leading pharmaceutical companies for both developed and emerging markets.
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About Strides Arcolab Limited
Strides Arcolab, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.
The company has 14 manufacturing facilities across 6 countries with presence in more than 75 countries in developed and emerging markets. Manufacturing is ably supported by a 350-scientist strong global R&D Centre located in Bangalore.
Additional information is available at the company’s website at www.stridesarco.com.