The Indore based Choksi Laboratories Ltd received US FDA approval for its drug testing laboratory to conduct contract testing services as per the standards of the US Drug Administration.
In its inspection at Indore, the US FDA officials classified the laboratory as acceptable for contract testing laboratory services, which makes the facility one of the very few contract testing laboratories in India to be accepted by the American regulatory, informed officials from Choksi. The audit was conducted in response to multiple ANDAs filed by a foreign pharmaceutical manufacturer using the company's analytical data.
The laboratory provides a dedicated team to pharmaceutical sponsors looking for approved, confidential and secure laboratory facilities, complying to 21 CFR Parts 210 and 211 (cGMPs), according to the company officials.
Currently, the company provides analytical services such as analytical method development (AMD), analytical method validation (AMV), stability studies, residual solvents characterization and quantification, drug release studies, particle size and distribution analysis, microbiological identification (automated and conventional) and trace element detection and quantification. It also provides niche services such as mass characterization of new drug molecules and its impurities using various modern techniques, analysis of medical devices (cardiac stents, ocular implants etc) for residues of sterilization gases and ageing studies, and analysis of water for pharmaceutical preparations as per norms of various foreign and international quality standards.
The company has also branch laboratories in Vadodara, Vapi and Panchkula, with an overall technical staff of more than two hundred. Choksi Lab which is currently in its silver jubilee year can now offer its services to the pharmaceutical manufacturers who are exporting to US, averred company officials.