04-12-2023 10:21 AM | Source:
Granules India moves up as its arm gets USFDA`s approval for Sildenafil for Oral Suspension

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Granules India is currently trading at Rs. 397.00, up by 4.30 points or 1.09% from its previous closing of Rs. 392.70 on the BSE.

The scrip opened at Rs. 400.55 and has touched a high and low of Rs. 400.55 and Rs. 393.80 respectively. So far 16313 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 1 has touched a 52 week high of Rs. 404.75 on 01-Dec-2023 and a 52 week low of Rs. 267.85 on 29-Mar-2023.

Last one week high and low of the scrip stood at Rs. 404.75 and Rs. 375.80 respectively. The current market cap of the company is Rs. 9624.46 crore.

The promoters holding in the company stood at 41.96%, while Institutions and Non-Institutions held 28.54% and 29.50% respectively.

Granules India’s wholly owned foreign subsidiary - Granules Pharmaceuticals, Inc (GPI) has received US Food & Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) for Sildenafil for Oral Suspension, 10 mg/mL. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Revatio for Oral Suspension, 10mg/ml, of Viatris Specialty LLC. 

Sildenafil for Oral Suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening.

Granules now has a total of 63 ANDA approvals from the US FDA (61 final approvals and 2 tentative approvals). The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million, according to MAT September 2023, IQVIA/IMS Health. 

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).