Moneycontrol
Last Updated : Apr 27, 2020 12:30 PM IST | Source: Moneycontrol.com

JB Chemicals, Granules share price up 2-4% on USFDA approval

Granules has a total of 27 ANDA approvals from US FDA (25 Final approvals and 2 tentative approvals).

Q. The Drug controller general of India has allowed restricted use of Kaletra the combination of medications lopinavir and ritonavir, for treating those affected by novel coronavirus after the Indian Council of Medical Research (ICMR) sought an emergency approval for the same. Use of Kaletra was allowed based on the fact that previous studies suggested Kaletra, as effective in preventing SARS from maturing and replicating. It has already achieved good results in China and Japan in curing Coronavirus. What was Lopinavir and Ritonavir originally used for?
Q. The Drug controller general of India has allowed restricted use of Kaletra the combination of medications lopinavir and ritonavir, for treating those affected by novel coronavirus after the Indian Council of Medical Research (ICMR) sought an emergency approval for the same. Use of Kaletra was allowed based on the fact that previous studies suggested Kaletra, as effective in preventing SARS from maturing and replicating. It has already achieved good results in China and Japan in curing Coronavirus. What was Lopinavir and Ritonavir originally used for?
 
 
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Shares price of JB Chemicals and Granules India gained 2 percent and 4 percent respectively after the companies received US FDA approval.

US Food & Drug Administration (USFDA) has approved JB Chemicals' abbreviated new drug application (ANDA) for Carbamazepine Extended-Release Tablets USP 100 mg, 200 mg and 400 mg. (for treatment of Epilepsy and Trigeminal Neuralgia).

The product is a generic version of Tegretol XR tablet in the same strength of Novartis Pharmaceuticals Corp.

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The Company plans to commercialise this product in Q3 of this financial year and is expected to boost the Company's US sales.

USFDA has also approved the ANDA filed by Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of Granules India for Vigabatrin for Oral Solution USP, 500 mg.

It is bioequivalent to the reference listed drug product (RLD), Sabril (vigabatrin) for Oral Solution, 500 mg, of Lundbeck Pharmaceuticals LLC.

Granules now has a total of 27 ANDA approvals from US FDA (25 Final approvals and 2 tentative approvals).

At 09:30 hrs, Granules India was quoting at Rs 173.75, up Rs 6.45, or 3.86 percent and JB Chemicals was quoting at Rs 559, up Rs 6.35, or 1.15 percent on the BSE.
First Published on Apr 27, 2020 12:30 pm
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