We have several pieces of news coming out of India drugmakers this week. Sun Pharma's Dilip Shanghvi, after taking a huge 99% pay cut, landed among the lowest-paid Indian pharma CEOs. The FDA refused to approve Dr. Reddy's generic versions of Teva's Copaxone and Merck & Co.'s NuvaRing. Natco Pharma is eyeing expansion in China as revenues and profit decline, and its API plant near Hyderabad was just hit with a Form 483. And more.
Sun Pharma may be the largest Indian drugmaker, but its helmsman just landed among the poorest-paid of his peers. Sun’s managing director, Dilip Shanghvi, took home only Rs 262,801 ($3,690) for the fiscal year ended March, a huge 99% cut over the previous year. The plunge came as allegations of Sun’s dubious governance practices sent its stock to a six-year low in January. Divi’s Laboratories chief, Murali Divi, with a 48% hike to about $8.2 million, was the highest-paid in India’s pharma industry.
Dr. Reddy’s Laboratories’ chief executive, G V Prasad, snagged a pay increase in the previous fiscal year despite the repeated manufacturing violations the FDA had uncovered. Now, the FDA has rejected the Indian drugmaker’s applications for generics of Teva’s Copaxone and Merck & Co.’s NuvaRing. The company didn’t explain what the FDA’s concerns are or say whether they are product-specific or manufacturing-related.
India’s Natco Pharma said the FDA had issued a Form 483 to its API facility near Hyderabad. None of the six observations involved data integrity, but there were lapses in the quality control lab, the company disclosed. The news came as Natco recorded a 21% drop in net profit for the quarter ended June as revenues declined 10.6%. Amid generic headwinds in the U.S., the company is now eyeing China for diversification.
GE Healthcare and Japanese IT services firm Fujitsu’s Australian division will collaborate to develop artificial intelligence tools to quickly and automatically diagnose brain aneurysms. The partnership hopes to offer a commercial product in Australia before going worldwide.
The FDA issued India-based Emcure Pharmaceuticals a warning letter after investigators found the company didn’t properly identify why its amikacin sulfate and prochlorperazine edisylate contained microorganisms. In late May, Heritage Pharmaceuticals issued a voluntary recall of those Emcure drugs in the U.S. after microbial growth was found in unreleased lots.
The valsartan mess connected to some potential cancer-causing agents has spread to another link in the pharma supply chain. The FDA this month sent a warning letter to Indian solvent recovery firm Lantech Pharmaceuticals, saying its processing methods might have contributed to cross-contamination that led to two carcinogens showing up in “sartan” blood pressure drugs.