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Granules announced that US Food & Drug Administration (US FDA) has approved its ANDA for Venlafaxine Hydrochloride Extended-Release Capsules.
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Hyderabad: Hyderabad-based Granules India reported a 31.3 per cent decline in its net profit for the third quarter ended December 2021. The company’s profit stood at Rs 101 crore compared to Rs 147 crore reported during the corresponding period of the previous year. The dip in profit is driven by reduction in gross margin and […]
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Hyderabad: Hyderabad-based Granules India said 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 of the company, for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 150 mg and 300 mg. It is bioequivalent to the reference listed drug […]
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Hyderabad: Hyderabad-based Granules India said that Granules Pharmaceuticals, a wholly owned foreign subsidiary of the company, located in Chantilly, Virginia, USA had undergone a Pre-approval Inspection (PAI) by the US Food and Drug Administration (US FDA) from 24th to 28th January 2022. The audit is a PAI for two of its product applications filed from […]
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Hyderabad: Hyderabad-based pharmaceutical company Granules India appointed Dr KVS Ram Rao as joint managing director & CEO with effect from January 05, 2022. Dr Rao has over two decades of experience in pharmaceutical and chemical industries. Dr Ram Rao holds a bachelor’s degree in chemical engineering from Osmania University, Hyderabad, and a master’s degree & […]
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Hyderabad: Granules Pharmaceuticals Inc (GPI), a wholly owned foreign subsidiary of Hyderabad-based Granules India, received the US Food & Drug Administration (US FDA) approval for the Abbreviated New Drug Application (ANDA) for Prazosin Hydrochloride Capsules, USP 1mg, 2mg and 5mg. It is bioequivalent to the reference listed drug product (RLD), Mini plus capsules 1Mg, 2Mg […]
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Hyderabad: Granules India, a vertically integrated pharmaceutical company based in Hyderabad, appointed Sucharita Rao Palepu as non-executive independent director on the Board of the company with immediate effect. Sucharita brings with her experience of two decades in IT and financial services. She is currently a strategic advisor specialising in organization & HR transformation initiatives, prior […]
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Hyderabad: Hyderabad-based Granules India announced that Granules USA, a wholly owned foreign subsidiary of the company located in New Jersey, NY, is voluntarily recalling one batch of Naproxen Sodium 220 mg tablets at a retail level due to a minor “Current Good Manufacturing Practice deviation”. Naproxen Sodium, a non-steroidal anti-inflammatory drug (NSAID), is used to […]
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The drug will be manufactured at the Granules manufacturing facility located at Gagillapur, Hyderabad.
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The audit is a pre-approval inspection for three of its applications filed from this facility. The FDA issued two minor observations during the audit.
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Says there has been a steep decline in Covid cases at all its facilities across Hyderabad and Vizag
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The drug firm plans to invest about Rs 180 crore on a Multiple Units Pellet System (MUPS) block, around Rs 250 crore on expanding active pharmaceutical ingredients (API) capacity.
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Hyderabad-based company to provide one crore tablets every week, starting today, aggregating to 16 crore tablets worth Rs 8 crores over next four months to fight the Covid-19 pandemic
