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Results For "ANDA-filings"

31 News Found

Strides receives USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets
Drug Approval | October 05, 2023

Strides receives USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets

The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products


Strides receives USFDA approval for Icosapent Ethyl capsules
Drug Approval | October 04, 2023

Strides receives USFDA approval for Icosapent Ethyl capsules

The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin


Strides receives USFDA approval for Icosapent Ethyl Capsules
Drug Approval | September 25, 2023

Strides receives USFDA approval for Icosapent Ethyl Capsules

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)


Strides receives tentative USFDA approval for Dolutegravir/Lamivudine/Tenofovir Disproxil Fumurate tablets
Drug Approval | September 16, 2023

Strides receives tentative USFDA approval for Dolutegravir/Lamivudine/Tenofovir Disproxil Fumurate tablets

Approval of this product under the PEPFAR program completes Strides’ qualification to all major markets and donor programs including Global Fund and South Africa


Strides receives tentative USFDA approval for Dolutegravir tablets
Drug Approval | September 15, 2023

Strides receives tentative USFDA approval for Dolutegravir tablets

The products will be manufactured at the company's facility in Bengaluru


Strides receives USFDA approval for Sevelamer Carbonate for oral suspension
Drug Approval | September 11, 2023

Strides receives USFDA approval for Sevelamer Carbonate for oral suspension

The products will be manufactured at the company's facility in Bengaluru


Strides receives USFDA approval for Mycophenolate Mofetil for oral suspension
Drug Approval | August 31, 2023

Strides receives USFDA approval for Mycophenolate Mofetil for oral suspension

The approval bolsters the company's Mycophenolate Mofetil portfolio


Lupin Q2 FY23 revenue up 3.9%; Profit down 71%
News | February 10, 2023

Lupin Q2 FY23 revenue up 3.9%; Profit down 71%

With the recent sales force expansion and new product launches, we expect to be back to above-market growth


Alembic Pharmaceuticals Q3 FY23 revenue up 19% to Rs. 1,509 Cr
News | February 07, 2023

Alembic Pharmaceuticals Q3 FY23 revenue up 19% to Rs. 1,509 Cr

Net sales for 9M FY23 up 9% to Rs. 4,246 crore and net profit for 9M FY23 at Rs. 189 crore


Strides receives USFDA approval for Potassium Chloride Oral Solution
Drug Approval | November 19, 2022

Strides receives USFDA approval for Potassium Chloride Oral Solution

The approval further strengthens the Potassium Chloride franchise for the company.