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Results For "ANDA-approval"

201 News Found

Alembic receives USFDA final approval for Cyclophosphamide Capsules
Drug Approval | November 14, 2022

Alembic receives USFDA final approval for Cyclophosphamide Capsules

Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA.


Lupin Q2 FY2023 revenue remains flat
News | November 10, 2022

Lupin Q2 FY2023 revenue remains flat

Investment in R&D was Rs. 337.6 crore (8.3% of sales) for Q2 FY2023 as compared to Rs. 330 crore (8.2% of sales) for Q2 FY2022.


Alembic receives USFDA approval for Ketorolac Tromethamine Injection
Drug Approval | November 04, 2022

Alembic receives USFDA approval for Ketorolac Tromethamine Injection

Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients


Alembic receives USFDA approval for Mesalamine ER Capsules
Drug Approval | November 03, 2022

Alembic receives USFDA approval for Mesalamine ER Capsules

Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.


Alembic Pharma gets USFDA approval for Glycopyrrolate Injection USP
Drug Approval | November 01, 2022

Alembic Pharma gets USFDA approval for Glycopyrrolate Injection USP

This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.


Gland Pharma’s Q2 FY23 revenue stood at Rs. 1,044.4 Cr
News | October 27, 2022

Gland Pharma’s Q2 FY23 revenue stood at Rs. 1,044.4 Cr

Gland Pharma Q2 FY2023 consolidated net profit up at Rs. 241.24 Cr


Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP
Drug Approval | August 29, 2022

Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP

he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).


Lupin Q1 FY23 consolidated loss drops to Rs. 89.08 Cr
News | August 04, 2022

Lupin Q1 FY23 consolidated loss drops to Rs. 89.08 Cr

Lupin is the 6th largest company in the Indian Pharmaceutical Market


Alembic receives USFDA tentative approval for Dasatinib tablets
Drug Approval | June 12, 2022

Alembic receives USFDA tentative approval for Dasatinib tablets

Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive


Alembic Pharmaceuticals receives USFDA final approval for Pirfenidone tablets
Drug Approval | May 24, 2022

Alembic Pharmaceuticals receives USFDA final approval for Pirfenidone tablets

The tablets have an estimated market size of US $ 548 million for twelve months ending December 2021 according to IQVIA