Sun Pharma to seek re-inspection of non-compliant Halol plant
- Sun Pharma will seek a re-inspection of its Halol manufacturing plant from the FDA after the U.S. regulator sent Sun a warning letter last year related to quality and compliance issues at the facility.
- Speaking in an investor call, managing director Dilip Shanghvi said Sun would request a re-inspection in the first quarter of 2017, according to the Economic Times.
- The Halol plant has been the target of FDA scrutiny for some time. When it received the most recent letter, Sun had already been working to fix previous violations.
Sun Pharma is India's largest drugmaker and a significant supplier of drugs to the United States. The Halol plant specializes in injectables and accounts for roughly 15% of Sun's sales to the U.S., according to Reuters.
In the December warning letter, the FDA identified a number of violations of current good manufacturing processes (CGMP). "Your quality system does not ensure the quality, safety, and effectiveness of your drug products. It is essential that executive management systematically improve their oversight of manufacturing quality to ensure sustainable quality assurance," the letter said.
Five of Sun's other plants are currently on the FDA's import ban list.
The FDA has stepped up its oversight of India-based drug manufacturing facilities, issuing 12 warning letters related to CGMP violations last year. India and China together manufacture about 80% of the active pharmaceutical ingredients in the world's drugs, raising concerns over the quality of manufacturing processes in both countries.
- Economic Times Sun Pharma to ask FDA in Q1 FY17 for Halol re-inspection
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