[ad_1] Drugmaker Indoco Remedies Ltd on Friday (October 11) announced that its Goa plant-II and III facilities, located in the Verna Industrial Area, have been classified as ‘Official Action Indicated’ (OAI) by the US Food and Drug Administration (US FDA). The OAI status follows an inspection conducted by the US FDA in July 2024 and […]
Glenmark Pharma Aurangabad unit clears FDA test – CNBC TV18
[ad_1] Drug firm Glenmark Pharmaceuticals Ltd on Friday (September 20) said its formulation manufacturing facility in Chhatrapati Sambhaji Nagar (Aurangabad), has successfully completed a routine inspection by the US Food and Drug Administration (FDA). “This is to inform you that the U.S. FDA has issued Form 483 with zero observations after an inspection at the […]
Jubilant Pharmova subsidiary gets US FDA note for Washington unit – CNBC TV18
[ad_1] Drug firm Jubilant Pharmova Ltd on Tuesday (September 10) said its subsidiary, Jubilant HollisterStier LLC (JHS), has received a communication from the US Food and Drug Administration (FDA) regarding its Spokane, Washington, contract manufacturing facility. Following an audit conducted from May 28 to June 6, 2024, the US FDA has classified the facility’s inspection […]
Granules India’s Gagillapur facility completes US FDA inspection with 6 observations – CNBC TV18
[ad_1] Drug firm Granules India Ltd on Saturday (September 7) said its Gagillapur facility in Hyderabad, Telangana, has completed a US Food and Drug Administration (USFDA) inspection, concluding with six observations. The inspection, which took place from August 26 to September 6, 2024, focused on both Current Good Manufacturing Practice (cGMP) and Pre-Approval Inspection (PAI) […]
Biocon arm Biocon Pharma receives US FDA approval for Daptomycin injection – CNBC TV18
[ad_1] Biotechnology firm Biocon Ltd on Friday (August 30) said its wholly owned subsidiary Biocon Pharma Ltd has received approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Daptomycin for injection (500mg vial). “This is to inform you that Biocon Pharma Limited, a wholly-owned subsidiary of […]
FDC’s Baddi unit passes US FDA inspection with Zero 483 observations – CNBC TV18
[ad_1] Pharma company FDC Ltd on Friday (August 23) said its manufacturing facility in Baddi, Himachal Pradesh, which specialises in Cephalosporin oral dosage forms, has successfully passed a recent inspection by the US Food and Drug Administration (FDA). “…we are pleased to inform you that the U.S. Food and Drug Administration (FDA) had conducted an […]
Sun Pharmaceutical’s Leqselvi faces legal challenges in US launch – CNBC TV18
[ad_1] Sun Pharmaceutical Industries Ltd’s alopecia drug Leqselvi (Deuruxolitinib) approved by the US Food and Drug Administration (USFDA) earlier this month could see immediate legal hurdles when it comes to its launch. A motion seeking a preliminary injunction has been filed in a US court to prevent the product’s launch. The management cannot comment on […]