Choksi Laboratories Ltd''s new laboratory based at Vapi has recently received approval from the FDCA, Gujarat. This is the third FDA-approved laboratory of the group, the other two being Indore (in Madhya Pradesh) and Vadodara. These labs have been successfully catering to the pharmaceutical majors of India, since 1993.
Choksi Labs is a leading name in the drugs and pharmaceuticals testing.
The Vapi Laboratory would be extending its current gamut of services to manufacturers of injectables, ophthalmic solutions, IV sets, drug formulations, and raw materials. Besides this, water for use in injectables and in cleaning (raw water) will also be analyzed.
The Vapi laboratory is equipped with Particle Size Analyzer from Melwarn (Germany), FTIR from Shimadzu (Japan) for organic compound analysis, Gradient HPLCs and UV-Vis Spectrophotometer from Merck (Germany) for high accuracy, high sensitivity analysis of drugs, water and chemicals, Gas Chromatographs with Head Space (Shimadzu-Japan) for quantification of Organic Volatile Impurities, US FDA Class 100 clean rooms for sterility - all the instruments conform to USP norms.
The company says that there has been a perceptible change in analytical outsourcing market. Large pharmaceutical companies are moving from the concept of contract laboratories. With the latest approval, the company shall be able to target not only new clients in Maharashtra and Gujarat, but also provide extended quality assurance service to its new clients.
Some of the novel services being started for the first time in India by Choksi Laboratories include In-Plant Bio-burden and Residual Antibiotic study and Analytical Calibration. The former involves use of high volume samplers to study the bacterial burden or antibiotic content in ambient air quality. Analytical Calibration, on the other hand, is of use for pharma companies to comply with GMP, US FDA, or the recent Schedule M guidelines of the Indian government.
The company is also in the process of applying to the FDA for approval of its Ayurvedic/ Herbal analysis division. This division has already been serving the industry leader - Dabur - for some time now. CCL is committed to provide its client best bet for their money.