News about "Active Pharmaceutical Ingredients "

FDA Announces New ANDA Prioritisation Pilot to Support US Generic Drug Manufacturing and Testing

More than half of pharmaceuticals distributed in the US are manufactured overseas. Further, the US is reliant on overseas sources for Active Pharmaceutical Ingredients (APIs). As of 2025, only nine percent of API manufacturers are in the US, compared to 22 percent in China and 44 percent in India.

Active Pharmaceutical Ingredients | 06/10/2025 | By Dineshwori |  104

Supriya Lifescience Secures WHO GMP Certification for Ambernath Facility

The WHO certification for Supriya Lifescience paves way for commercial formulations’ production with INR 500 crore revenue potential.

Active Pharmaceutical Ingredients | 04/10/2025 | By Dineshwori |  217

SwRI Scientists Develop Ion-Assisted Chromatography Process to Accelerate Drug Development

Scientists at Southwest Research Institute have accidently made a discovery of an ion-assisted chromatography process to accelerate drug development.

Active Pharmaceutical Ingredients | 28/08/2025 | By Dineshwori |  121

NATCO Launches Tracleer Generic in US with Lupin

NATCO Pharma has announced the launch of Bosentan tablets for oral suspension (TFOS), 32mg, a generic version of Tracleer by Actelion Pharmaceuticals US Inc., in partnership with Lupin.

Active Pharmaceutical Ingredients | 20/08/2025 | By Dineshwori |  216

Veranova Names Thomas Rohrer as Vice President of Bioconjugation

Veranova, a global leader in the development and manufacturing of specialty and complex active pharmaceutical ingredients (API) for the pharmaceutical and biotech sectors, has appointed Thomas Rohrer as Vice President of Bioconjugation.

Active Pharmaceutical Ingredients | 29/07/2025 | By Dineshwori |  175

Medicines UK Hails India-UK Trade Deal, Calls for Clear Regulatory Pathway

Medicines UK has called for the establishment of a clear regulatory framework to fully unlock the benefits of the newly signed Comprehensive Economic and Trade Agreement (CETA) between India and the UK.

Active Pharmaceutical Ingredients | 25/07/2025 | By Dineshwori |  175

India Clears 48 Projects Under PLI Scheme to Boost Domestic Production of Key Drug Ingredients

A total of 48 projects have been approved under the Production Linked Incentive (PLI) Scheme to boost domestic manufacturing of critical Key Starting Materials (KSMs), Drug Intermediates (DIs), and Active Pharmaceutical Ingredients (APIs) in India, according to the Ministry of Chemicals and Fertilizers.

Active Pharmaceutical Ingredients | 23/07/2025 | By Dineshwori |  378

Dr. Reddy's Srikakulam Facility Gets Form 483 After USFDA Inspection

Dr. Reddy’s Laboratories has received a Form 483 with seven observations from the United States Food and Drug Administration (USFDA) following an inspection at its formulations manufacturing facility in Srikakulam, Andhra Pradesh.

Active Pharmaceutical Ingredients | 19/07/2025 | By Dineshwori |  455

Amphastar to Expand US Manufacturing Footprint, Quadruple Production Capacity

Amphastar Pharmaceuticals aims to quadruple its production capacity at its headquarters in Rancho Cucamonga, California over the next three to five years.

Active Pharmaceutical Ingredients | 16/07/2025 | By Dineshwori |  132

Global API Market Expected to Reach USD 422.8 Billion by 2034

The global Active Pharmaceutical Ingredients (API) market is projected to grow at a compound annual growth rate (CAGR) of 6.7 percent to an estimated USD 422.8 billion by 2034, according to a report.

Active Pharmaceutical Ingredients | 09/07/2025 | By Dineshwori |  156