To improve common standards for global development for generics and access to generics, FDA has launched the Generic Drug Cluster through the Global Generic Drug Affairs team established by the FDA’s Office of Generic Drugs. The agency has listed objectives through which it aims to increase scientific alignment among leading generic drug regulatory agencies. 

To improve common standards for global development for generics and access to generics, FDA has launched the Generic Drug Cluster through the Global Generic Drug Affairs team established by the FDA’s Office of Generic Drugs. The agency has listed objectives through which it aims to increase scientific alignment among leading generic drug regulatory agencies. 

India’s Granules has grown through increased market penetration of its existing products as well as new product launches. The company is planning to invest in expanding its API capacity, finished dosages and a new multiple unit pellet facility.

After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.

Torrent Pharma has reported a double-digit drop in its US revenues after discontinuing its sartan portfolio, due to the presence of trace amounts of N-nitrosodimethylamine. The company saw its domestic market grow aided by market share gains in high potential new launches.

India’s Zydus Cadila is working on strengthening its pipeline with 35 product approvals from the FDA over the course of its most recent financial year. The company also filed for 22 new ANDAs during FY2021. And ahead of recently launching the world’s first biosimilar to Roche’s Kadcyla (trastuzumab emtansine) in India, the company reported significant growth in its domestic business.