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Specialty Ranbaxy seeks FDA nod for Mumbai lab

BS Bureau

Specialty Ranbaxy, a diagnostics services company of the Ranbaxy group, is seeking quality certification from the United States Food and Drug Administration for its clinical research laboratory in Mumbai.

The US FDA authorities will be inspecting the laboratory some time in May or June. The company is also expecting the accreditation of the College of American Pathologists soon.

Vidur Kaushik, chief executive officer, Specialty Ranbaxy, and Sumedha Kaushik, director (operations), said the laboratory went through nine international audits during the last year for certifying its good laboratory practices.

Specialty Ranbaxy was the first clinical testing laboratory in the country to be accredited by the National Accreditation Board for Testing and Calibration Laboratories, a certifying authority under the Ministry of Science and Technology.

Sumedha said only 14 laboratories out of 25,000-odd clinical labs in the country are currently accredited by NABL.

Specialty Ranbaxy's main laboratory in Mumbai, along with three more smaller labs located in Delhi, Bangalore and Mohali, conducts about 4 million tests a year. The company is planning to start a laboratory in Hyderabad soon. The company has about 150 field staff spread over 200 towns and 500 collection centres.

Specialty Ranbaxy has long-term arrangements with private hospitals such as Breach Candy, Jaslok, P D Hinduja, Lilavati in Mumbai, Indraprasth Apollo in Delhi, and Wockhardt, Mallya and Manipal Hospitals in Bangalore for carrying out clinical tests, Sumedha said.

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