Mumbai: Sun Pharma, the largest pharma company by revenue and market share in India, has received a clearance for its Halol facility from a Dutch drug regulator on January 10, 2018.
Halol is an important facility for Sun Pharma, holding a key for Sun Pharma’s US formulation business. The company’s US business has been impacted for the last couple of years, as ANDA approvals have been delayed due to the observations at Halol.
The Halol facility received nine observations in the re-inspection by USFDA in Q3FY17. Since the last inspection, Sun Pharma has completed the remediation process and has also been shifting products to alternate manufacturing sites. The company has invited the USFDA to inspect the Halol facility in the second week of February 2018.
The approval from the Dutch regulator is not going to impact US business as of now, however, it should be viewed as positive, as the regulatory bodies in the US and Europe have strict compliance standards.
Sun Pharma’s US formulations and Indian branded Generics contributed 45% and 26% respectively to FY17 revenue while Emerging markets, ROW and API contributed 15%, 9%, and 5% respectively. It has a strong pipeline for the US market with 136 ANDAs and 4 NDAs awaiting approval.