Choksi Labs gets approval from FDA
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.
Orphan drug application process to ease in U.S., Europe
WASHINGTON & LONDON The Food and Drug Administration, European Commission and European Medicines Agency have decided to ease the application process for orphan drugs, drugs that are necessary but would be expensive and unprofitable to develop, in a move aimed at increasing the development of treatments for rare diseases, according to Reuters.
The agencies have adopted a common application, which would allow drug companies to apply to both regions at the same time with one application.
Rare diseases are defined as those affecting fewer than five in 10,000 people in the European Union and fewer than 200,000 people in the United States. About 30 million people in the European Union and about 25 million Americans suffer from more than 6,000 rare diseases.
India’s drug makers move beyond generics
NEW DELHI, India
India’s big pharmaceutical companies are moving from generic drug manufacturing to introducing their own originally researched drug molecules, which are expected to hit the market by 2010-11, according to published reports.
Among the companies involved in research and development of the new molecules are Ranbaxy, Glenmark and Dr. Reddy’s. Altogether about 10 to 12 companies have molecules under various stages of development.
Research and development investments now account for as much as 7 percent to 9 percent of sales. For example, Ranbaxy invested $80 million in research and development in 2006-07; this year that number has gone up to $100 million.
The key for these companies will be to partner with more experienced pharmaceutical manufacturers to help conduct more original research and development on new drugs.