MUMBAI, India U.S. pharma companies can now outsource their contract testing services to a lab company in India.
After an inspection by the Food and Drug Administration, Choksi Laboratories was approved for use, company officials said Wednesday. It will now offer its services to the pharmaceutical manufacturers who are exporting to United States. The labs are required to follow the standards of the FDA.
Choksi Laboratories, an Indore-based company, joins a handful of facilities in its niche that operate in India. The FDA’s audit of the lab was conducted in response to several filings of multiple abbreviated new drug applications, based on Choksi’s analytical data.
The laboratory provides a dedicated team to pharmaceutical sponsors looking for approved, confidential and secure laboratory facilities, according to the company officials.
Currently, the company provides several analytical services, including stability studies and drug release studies, in addition to providing other specialty services.
Choksi has additional laboratories in Vadodara, Vapi and Panchkula. The company has over 200 people on its technical staff.