Granules India jumps on USFDA nod for Trospium Chloride capsules

Granules India rose 4.36% to Rs 167.50 after the company said its received approval of Trospium Chloride ER capsules, 60 mg.

Granules India announced on Friday, 24 April 2020, that the US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly-owned foreign subsidiary of Granules India for Trospium Chloride extended-release capsules, 60 mg. It is bioequivalent to the reference listed drug product (RLD), Sanctura XR Capsules, 60 mg, of Allergan, Inc.

Trospium Chloride extended-release capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (CAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

 

Trospium Chloride extended-release capsules, 60 mg had US sales of approximately $25 million MAT for the most recent twelve months ending in February 2020 according to IQVIA Health. Granules now has a total of 26 ANDA approvals from US FDA (24 Final approvals and 2 tentative approvals).

On a consolidated basis, Granules India's net profit rose 6.15% to Rs 64.03 crore on 11.42% rise in net sales to Rs 703.96 crore in Q3 December 2019 over Q3 December 2018.

Granules India is a growing pharmaceutical manufacturing company. The company produces finished dosages (FDs), pharmaceutical formulation intermediates (PFIs) and active pharmaceutical ingredients (APIs).

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