Granules India gets USFDA approval for ANDA; stock surges

Granules India has received US Food & Drug Administration (USFDA) approval for abbreviated new drug application (ANDA), Trospium Chloride extended-release capsules, 60 mg. It was filed by Granules Pharmaceuticals, Inc (GPI), a wholly-owned foreign subsidiary of Granules India Limited.

It is bioequivalent to the reference listed drug product (RLD), Sanctura XR capsules, 60 mg, of Allergan, Inc.

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

As per IQVIA Health’s data, Trospium Chloride extended-release capsules, 60 mg had US sales of approximately $25 million MAT for the most-recent twelve months, ending February 2020.

In the same month, the company had got another USFDA approval for ANDA of Butalbital, Acetaminophen and Caffeine capsules USP, 50 mg/300 mg/40 mg, respectively. These capsules are used for the relief of symptom complex of tension (or muscle contraction) headache.

Granules India now has a total of 26 ANDA approvals from USFDA (24 final approvals and two tentative approvals).

On Friday, the stock of Granules surged 5.8 per cent to Rs 169.80 from its previous close of Rs 160.50 on BSE.