Sun Pharma to ask FDA in Q1 FY17 for Halol re-inspection

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26 Aug, 2025 12:21

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Drug major Sun Pharmaceutical Industries may ask the US health regulator in the first quarter of next fiscal for re-inspection of its Halol facility as it undertakes remediation measures to make the plant compliant to good manufacturing practice norms.

"We hope to able to request USFDA in the first quarter of FY17 for re-inspection of the Halol facility," Sun Pharma Managing Director Dilip Shanghvi said during an investor conference call today.

The company is undertaking remediation efforts at the facility, he added.

On being asked if the company was considering production of some products manufactured at Halol facility at some other plant, Shanghvi said: "We are currently not considering site transfer for the Halol products".

The warning letter sent by the USFDA (United States Food and Drug Administration) over the Halol facility in December last year had mentioned that its inspectors had "identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals." Besides, the US health regulator found that Sun Pharma "failed to establish appropriate controls over computers and related systems to assure that changes in master production and control records or other records are instituted only by authorised personnel".

The significant violations included the company's failure "to maintain floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable in aseptic processing areas".

"Our investigator documented the presence of leaks in the form of water stains and ceiling damage in the parenteral manufacturing area personnel corridor", the letter had said.

Sun Pharmaceutical Industries today posted an over three-fold jump in its consolidated net profit at Rs 1,416.60 crore for the December quarter, driven by robust sales in domestic as well as international markets.

The drug major, which had posted a net profit of Rs 395.33 crore during the same period last fiscal, also said that it will 'mutually wind down' its joint venture with MSD Pharma's wholly-owned subsidiaries.