- Sun Pharma's ongoing compliance problems at its key Halol, India manufacturing facility continue to give the drugmaker, and its novel drug discovery spin off SPARC, new headaches.
- SPARC, or Sun Pharma Advanced Research Company, said last week the Food and Drug Administration had rejected its New Drug Application for Elepsia XR (levetiracetam) due to GMP violations at the Halol site where it is manufactured.
- Elepsia XR, which SPARC had licensed to a Sun Pharma subsidiary in July 2016, had actually been approved in 2015 but its license was rescinded when the Halol facility failed an inspection by the FDA.
In some ways, Sun Pharma's trouble to bring the Halol site up to code are emblematic of the ongoing regulatory issues the Indian drug manufacturing industry is experiencing.
The FDA has stepped up its oversight of foreign API and finished dose producers, issuing numerous warning letters to firms in India and China, as well as in Japan and other developed Asian countries. That scrutiny has hurt the industry's bottom line, leading to costly remediation efforts and delays.
Sun Pharma has been working to resolve the issues flagged by the FDA at the Halol site since receipt of a 2015 warning letter. Hopes of an all-clear were dashed, however, in December last year when a reinspection of the site turned up nine new observations.
Those observations, included in a Form-483, could lead to a new warning letter, further impeding the site's ability to win approval of and ship products to the U.S. market.
SPARC's notice of the rejection indicated resolution of the violations at Halol would be required before any final approval of Elepsia could be granted.