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News about "US Food and Drug Administration (USFDA)."
Alembic Secures Final USFDA Nod for Tretinoin Cream USP, 0.025%
Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tretinoin Cream USP, 0.025 percent, indicated for the treatment of acne vulgaris.
US Food And Drug Administration (USFDA) | 16/08/2025 | By Dineshwori | 119
FDA Launches PreCheck Program to Boost US Drug Manufacturing
The US Food and Drug Administration (USFDA) has unveiled a new program aimed at strengthening the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the United States.
US Food And Drug Administration (USFDA) | 11/08/2025 | By Dineshwori
Granules India's Shamirpet Manufacturing Unit Flagged by USFDA with Observation
Granules India has received one observation from the US Food and Drug Administration (USFDA) following a pre-approval inspection at its oral solid manufacturing facility located in Shamirpet, Hyderabad.
US Food And Drug Administration (USFDA) | 04/08/2025 | By Darshana | 110
Torrent Pharma's Vizag API Unit Passes USFDA Inspection with Zero Observation
The US Food and Drug Administration (USFDA) has completed the inspection of Torrent Pharma's API manufacturing facility located in Vizag, Andhra Pradesh.
US Food And Drug Administration (USFDA) | 04/08/2025 | By Dineshwori | 152
Sun Pharma, Lupin, Dr. Reddy's Recall Products in US over Manufacturing Defects and Product Mix-Ups
Three of India’s top pharmaceutical companies—Sun Pharma, Lupin, and Dr. Reddy’s Laboratories—have initiated product recalls in the United States following manufacturing issues and product mix-ups, as per information released by the US Food and Drug Administration (USFDA).
US Food And Drug Administration (USFDA). | 28/07/2025 | By Darshana | 181
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