The approval comes "at a time when we are poised for an exponential growth in our exports" and after a stringent inspection of manufacturing, quality control, quality assurance, R&D and documentation sections of the plant, a company release said. The plant, built upon the GMP guidelines of the European Community, deploys seven colours of the rainbow for total segregation of activities. This novel concept, introduced for the first time in India, totally eliminates the possibilities of criss-crossing and contamination. Spread over a 44 acre piece of land, Cadila Pharma's Dholka plant is set amidst abundant flora. The habitat is free from any risks of metropolis air pollution, fumes, industrial wastes and pests.

Amidst many other novel features, meticulous care has been taken in designing and execution of water systems to this plant. Further, to comply with the USFDA requirements, the raw water undergoes primary treatment of coagulation, chlorination, dechlorination, filtration and dual pass RO system. Separate sanitary water circulation loops for purified water and water for injection with on-line monitoring and control for TOC, conductivity, pH, temperature and microbial counts have been installed.

Cadila's "Indradhanush" plant has already won many laurels including the Japanese, RD Congo and World Health Organisation GMP certifications. The plant complex also houses a world-class research facility for new molecules development, clinical studies, formulations development, biotechnology, cellular microbiology and pharmacology.

With a clinical look, bio-equivalence studies centre and animal houses at Dholka, Cadila Pharma is geared up for fulfilling stringent regulatory requirements of lucrative European (MCA) and American (USFDA) markets. With a few DMF's (Drug Master Files) already filed with USFDA, the company is preparing for a number of ANDA's (abbreviated new drug applications) some of them for block busters to be submitted to USFDA next year.