Granules India gains after ANDA approval

Granules India rose 2.06% to Rs 176.05 after the company said it received US drug regulator's approval of Butalbital, Acetaminophen and Caffeine capsules USP.

Granules India announced on Thursday (9 April) that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly-owned foreign subsidiary, for Butalbital, Acetaminophen and Caffeine capsules USP, 50 mg/300 mg/40 mg.

The drug is bioequivalent to the reference listed drug product (RLD) of Nexgen Pharma, Inc and is used for the relief of the symptom complex of tension (or muscle contraction) headache.

Butalbital, Acetaminophen and Caffeine capsules USP, 50 mg/300 mg/40 mg had US sales of approximately $42 million MAT for the most recent twelve months ending in February 2020 according to IQVIA Health.

Granules now has a total of 25 ANDA approvals from USFDA (23 Final approvals and 2 tentative approvals).

Shares of Granules India scrip extended gains for the third day. The stock has added 24.81% in three sessions from a recent closing low of Rs 141.05 recorded on 3 April 2020.

On a consolidated basis, the drug maker's net profit rose 6.2% to Rs 64.03 crore on 11.4% rise in net sales to Rs 703.96 crore in Q3 December 2019 over Q3 December 2018.

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

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