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Lupin launches Posaconazole Delayed-Release Tablets expresspharma
February 18, 2021
They are indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised.
Alembic Pharma subsidiary, Alembic Global Holding SA gets USFDA final nod for Treprostinil injection expresspharma
February 18, 2021
Treprostinil injection is indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise.
Granules India gets US FDA nod for Potassium Chloride Oral Solution expresspharma
February 02, 2021
Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis.
Unichem gets USFDA approval for Zonisamide Capsules expresspharma
January 28, 2021
They are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
Strides get USFDA nod for Ursodiol capsules expresspharma
January 26, 2021
Strides Pharma Science announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte, Singapore, has received approval for Ursodiol Capsules USP, 300 mg from the United States Food & Drug Administration (USFDA).
FDA Publishes New Guidance on Protecting Participants in Bioequivalence Studies During COVID-19 americanpharmaceuticalreview
January 25, 2021
The U.S Food and Drug Administration (FDA) has published a new guidance for industry, Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.
Alembic Pharma gets final nod from USFDA for Midodrine Hydrochloride Tablets expresspharma
January 25, 2021
Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg.
JB Chemicals gets ANDA approval from US FDA for Loratadine Tablets expresspharma
January 12, 2021
The tablets are indicated for the treatment of allergic rhinitis caused by pollen and upper respiratory tract allergy for OTC use.
Lupin launches Mycophenolate Mofetil Tablets USP expresspharma
December 30, 2020
They are indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants.
Glenmark Pharma gets ANDA tentative approval for Dabigatran Etexilate Capsules expresspharma
December 22, 2020
It is the generic version of Pradaxa Capsules, 75 mg, 110 mg, and 150 mg, of Boehringer Ingelheim.

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