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US FDA Approval Archives - The Pharma Times | Pharma & Health Care News Portal

US FDA Approval

Cipla gets USFDA nod for inhalation product

Drug major Cipla NSE 0.65 % on Wednesday said it has received final approval from the US health regulator for Arformoterol Tartrate…

3 years ago

MSN Group receives US FDA approval for Asenapine Sublingual Tablets

- It is indicated for the treatment of Schizophrenia & Bipolar disorder  Hyderabad, December 19, 2020: MSN Group (MSN) announced…

3 years ago

Lupin’s Alliance Partner Concord Receives U.S. FDA Approval for Tacrolimus Capsules USP

Mumbai, November 12, 2020: Pharma major Lupin Limited (Lupin) in alliance with Concord Biotech Limited (Concord) announced today that it…

3 years ago

Lupin’s Inhalation Research Center, Florida receives EIR from U.S. FDA

Mumbai, March 30, 2020: Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) from the…

4 years ago

WuXi STA Shanghai & Changzhou Facilities Pass U.S. FDA Inspections

Shanghai, July 23, 2019: STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – announces that its Analytical Service Unit…

5 years ago

Dr. Reddy’s announces the launch of over-the-counter, store-brand equivalent of Allegra-D® 12 HR Allergy and Congestion Extended-Release Tablets (fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg) in the U.S. Market

Hyderabad, July 22, 2019: Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred…

5 years ago

Wockhardt Receives US FDA Approval for cancer drug

Mumbai, April 24, 2019: Pharmaceutical and biotechnology major Wockhardt has received approval from the United States Food & Drug Administration (US…

5 years ago

Lupin’s Pithampur Unit-3 (Indore) receives EIR from USFDA

Mumbai, April 18, 2019: Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) for its…

5 years ago

India pharmaceuticals market expected to reach USD 73.5 billion by 2023

Mumbai, April 08, 2019: Market Research Future (MRFR) in its latest analysis titled, “Withering USFDA inspections: The Quality Challenge for…

5 years ago

Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia

New Delhi, March 14, 2019: Eisai Co., Ltd. and Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue…

5 years ago
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