The company is investigating the matter with utmost priority, it informed in a regulatory filing. The appropriate containment and remediation actions are being taken in a controlled manner to address the incident, it added.
Granules' consolidated revenue from operations rose 16 per cent to 11.96 billion rupees, but a 17 per cent jump in its total expenses ate into the profit growth. Granules reported a 38 per cent jump in sales of paracetamol, which is both an API and a ready-for-consumption drug it sells only in the European Union.
Gabapentin tablets are indicated for management of postherpetic neuralgia in adults; and as an adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalisation, in adults and pediatric patients aged 3 years and older with epilepsy, the company added.
The company has received approval from the US Food & Drug Administration (USFDA) to market Losartan Potassium tablets in strengths of 25 mg, 50 mg, and 100 mg, Granules India said in a regulatory filing.
Amphetamine is bioequivalent to the reference listed drug product (RLD), Adderall XR extended-release capsules of Takeda Pharmaceuticals. This product will be manufactured at Granules manufacturing facility in Chantilly, Virginia, and is expected to be launched shortly, according to a company statement shared with stock exchanges.
The company said it was preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines. The company said it remains committed to maintaining the highest standards of compliance and will work closely with the agency to address all the observations comprehensively.
Loperamide Hydrochloride and Simethicone Tablets are indicated to relieve symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.
Bupropion Hydrochloride is used as an antidepressant medication to treat major depressive disorder and seasonal affective disorder.
Commenting on the audit, GPI Executive Director Priyanka Chigurupati said, "We are glad to have completed yet another audit with minor observations that we will respond to within the stipulated time period".
he US Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) for Potassium Chloride for Oral Solution filed by Granules Pharmaceuticals Inc (GPI), a wholly-owned foreign subsidiary of the company.
Rao has over two decades of experience in pharmaceutical and chemical industries.
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