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.
API Manufacturing | 06/10/2025 | By Dineshwori
Lilly Plans to Build USD 6.5 Billion Facility to Manufacture APIs in Texas
Eli Lilly will invest USD 6.5 billion to set up a new API manufacturing facility in Houston, Texas—its eighth US site since 2020—creating over 4,600 jobs and boosting domestic production of small molecule medicines.
API Manufacturing | 24/09/2025 | By Dineshwori | 111
The Bulk Drug Park at Una in Himachal Pradesh has received environmental clearance from the Union Ministry of Environment, Forest and Climate Change, a key milestone for India’s pharmaceutical infrastructure.
API Manufacturing | 13/09/2025 | By Darshana | 270
Cohance's Jaggaiahpet API Plant Clears USFDA Inspection with Zero 483 Observations
The United States Food and Drug Administration (USFDA) has completed a general current Good Manufacturing Practices (cGMP) audit at Cohance Lifesciences' API manufacturing facility (API Unit1) located at Jaggaiahpet, Andhra Pradesh, with zero Form 483 observations.
API Manufacturing | 12/09/2025 | By Dineshwori | 209
AbbVie to Invest USD 195 Million to Expand API Manufacturing in US
AbbVie will invest USD 195 million to expand active pharmaceutical ingredient manufacturing at its North Chicago plant, strengthening US production capacity for current and next-generation medicines.
API Manufacturing | 13/08/2025 | By Mrinmoy Dey
Orchid Pharma's Alathur API Facility Successfully Completes USFDA Inspection
Orchid Pharma has successfully completed a surprise USFDA inspection at its Alathur API facility, securing its status as India’s only USFDA-approved site for Sterile Cephalosporins. The facility also secures EU GMP certificate renewal for Cephalosporin API manufacturing.
API Manufacturing | 20/02/2025 | By Abha | 393
API Manufacturing | 19/09/2022 | By Sudeep Soparkar | 700
Bileshwar Pharma to set up API manufacturing unit in Dahej, Gujarat
The work is expected to commence by September 2024.
API Manufacturing | 06/09/2022 | By Sudeep Soparkar | 1146
Flow reactor brings down costs drastically while significantly increasing safety in API Manufacturing
API Manufacturing | 23/08/2022 | By Sudeep Soparkar | 678
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