Astral Pharmaceutical Industries having manufacturing facilities for sterile antibiotic powder injectables at Makarpura, Vadodara, was inspected by FDA, USA in January 2010 and has been classified as acceptable for manufacturing and marketing the product for USA.
Prior to the facility approval from USFDA Astral has received several regulatory accreditation including HPFBI-Canada, TGA-Australia, MCC-South Africa and ANVISA-Brazil.
Astral is the third formulation company and second sterile products manufacturing company from Vadodara to get USFDA approval that will pave a way to increase the presence of Gujarat Pharmaceutical companies in the US and other European markets.
Out of the US $16 billion (equivalent to Rs 66,000 crore) pharma exports from India, Gujarat contributes 22 per cent of total exports.
The company headed by Dushyant R Patel, President & CEO, Astral Pharmaceutical Industries, has already entered into strategic business tie up with Chicago-based Sagent Pharmaceutical Inc with whom more than 15 Abbreviated New Drug Application (ANDAs) have been filled for US market and more ANDA projects are in pipeline.
The facilities at Astral Pharmaceuticals Industries consists of two independent manufacturing infrastructure, one for Semi Synthetic Penicillin group of powder injectable products and the other for Cephalosporin range of injectable products. Astral has been recognised as a leading player in this segment and has been associated with MNC's and large Indian pharma companies, catering to their domestic as well as export segments.
Astral has registered their products to various regulatory and semi-regulatory markets across the world and is marketing the product under strategic alliance with reputed overseas associates. Astral is expected to launch the product very soon to US market.
