U.S. Drug Regulator Said To Start Inspection At Sun Pharma’s Halol Plant
The U.S. drug regulator is said to have started a surprise inspection at Sun Pharmaceutical Industries Ltd.’s Halol unit in Gujarat, three people with knowledge of the matter told BloombergQuint requesting anonymity.
The facility, which was recently cleared by the U.S. regulator, will manufacture most of the niche future filings from India’s largest drugmaker, including injectables.
A team of four inspectors of the U.S. Food and Drug Administration are inspecting the plant and examining records, according to one of three persons quoted above. The exact reason why these officials initiated the inspection was not known.
The company refused to comment on an email sent by BloombergQuint seeking confirmation of the development.
The Halol unit in June received an ‘establishment inspection report’ from the regulator post an inspection between Feb. 12 and 23 this year, paving the way for its first drug approval in five years from the plant—Infugem injection used for treating cancer.
Shares of Sun Pharma extended declines for the second straight session, falling as much as 1.5 percent to Rs 620.65 apiece in the intra-day trading.