News of Licenses | Approvals | Permissions in Gujarat

Dr. Reddy’s Labs gets USFDA nod to market insomnia treatment drug

HYDERABAD | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Bourses, Hyderabad based Indian pharma major Dr. Reddy’s Laboratories Ltd said of having got US FDA (Food & Drugs Administration) nod to market drug to treat insomnia (troubles having to fall asleep). The press release submitted to the Indian Stock

Alembic Pharma gets USFDA nod to market drug to treat diabetis

VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Bourses, Vadodara headquartered pharma major said of having got nod from US food and drug regulator to market drug to treat diabetis. The press release submitted by the comapany to the Indian Stock Exchanges read that, Alembic Pharmaceuticals

Laurus Labs’ exclusive distribution partner gets USFDA nod to market neuropathy treatment drugs

HYDERABAD | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Stock Exchanges, Hyderabad headquartered Laurus Labs said of its exclusive distribution partner in US getting rights from US FDA (Food & Drugs Administration) to market neuropathy treatment drug. The press release submitted by the company to the Indian Bourses

Alembic Pharma gets USFDA nod to market neuropathic treatment drug

VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Stock Exchanges, Vadodara (Baroda) Gujarat based pharma major Alembic Pharmaceuticals Ltd said of having received nod from US FDA (Food & Drugs Administration) to market neuropathic & diabetic treatment drug. In the press release submitted to the Indian

Cipla’s subsidiary co gets USFDA nod to market neuropathy treatment drug

NEW YORK (USA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Bourses, pharma major Cipla said of its subsidiary company InvaGen having got nod from US FDA (Food & Drugs Administration) to market neuropathy treatment drug. The press release submitted to the Indian Stock Exchanges read that Cipla’s

Sun Pharma launches sprinkler version of lipid-lowering treatment

VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Stock Exchanges, Vadodara (Baroda) headquartered pharma Sun Pharmaceutical Industries Ltd said of having announced the sprinkler version for lipid-lowering treatment. The company has launched Ezallor Sprinkle™ (rosuvastatin) capsules in U.S. for the treatment of three types of elevated

SPARC submits cancer treatment drug for approval to USFDA

VADODARA (BARODA) | MUMBAI | AHMEDABAD – GANDHINAGAR | RAJKOT – In a press release issued to the Indian Stock Exchanges, Vadodara headquartered Sun Pharma Advanced Research Company (SPARC) Ltd said of having filed abbreviated new drug application (ANDA) for caner treatment to USFDA (US Food & Drugs Administration), which has been accepted by the

Alembic Pharma gets USFDA nod to market drug to treat epilepsy & seizures

VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Stock Exchanges today, Vadodara (Baroda) headquartered Alembic Pharmaceuticals Ltd said of having received receives USFDA Approval for Clonazepam Orally Disintegrating Tablets USP, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 2 mg. The press release submitted by

Gujarat State Electricity Regulator nods Torrent’s power procurement plea

AHMEDABAD-GANDHINAGAR | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Ahmedabad headquartered Torrent Power Ltd said of having got approval from state electricity regulator for procurement arrangement of 278 MW power from the company’s UNOSUGEN power plant and its licensed power distribution business for the cities of Ahmedabad, Gandhinagar

Alembic Pharma gets USFDA nod to market drug to treat influenza

VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR-RAJKOT – In a press release submitted to the Indian Bourses, Vadodara (Baroda) headquartered Alembic Pharmaceuticals Ltd said of having got approval from US Food & Drugs Administration (USFDA) to market drug to treat influenza. The press release submitted to the Indian Stock Exchanges read where the company said, Alembic

Zydus Cadila gets USFDA nod to market high blood-pressure treatment drug

AHMEDABAD | MUMBAI | RAJKOT – In a press release submitted to the Stock Exchanges in India on Monday, Ahmedabad headquartered Zydus Cadila Group (Cadila Healthcare) said of having received the final approval from the USFDA (United States Food & Drugs Administration) to market Chlorthalidone Tablets USP (US RLD – THALITONE@),25 mg and 50 mg.

USFDA slams “certain observations” after inspecting Torrent Pharma’s Indrad facility

AHMEDABAD-GANDHINAGAR | MUMBAI | RAJKOT – In a regulatory update filing submitted to the Indian Bourses, Ahmedabad located pharma company  Torrent Pharmaceuticals Ltd said, inspection at Indrad Plant of the Company was carried out by US FDA in the month of April, 2019. The company has received certain observations which are procedural in nature and

Glenmark Pharma gets Russian Health Ministry’s nods to sell Nasal Sprays

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Exchanges, Mumbai headquartered Glenmark Pharmaceuticals Ltd., a research‐led, integrated global pharmaceutical company, today announced that it has received approval from the Ministry of Healthcare, Russia to market Momate Rhino (Mometasone Furoate 50 mcg) metered nasal spray as an over‐the‐counter (OTC) product

Alembic Pharma gets USFDA nod to market opthalmic (eye treatment) solution

VADODARA (BARODA) | MUMBAI | AHMEDABAD | GANDHINAGAR | RAJKOT – In a press-release submitted to the Indian Exchanges on Monday, Vadodara headquartered pharma major Alembic Pharmaceuticals Ltd said of US Food & Drugs Administration (USFDA) giving nod to the company to market Bimatoprost Ophthalmic Solution, 0.03%. According to IQVIA estimated market size for the

Wockhardt’s Bioequivalence Centre @ Aurangabad inspected by USFDA, no observations

AURANGABAD | MUMBAI | RAJKOT – In a regulatory update filing submitted to the Indian Bourses on Monday, India Pharma major Wockhardt Ltd said of  US Food and Drug Administration (USFDA) carried out inspection of Bioequivalence Centre located at R&D Centre, Aurangabad during which Bioequivalence studies of Tamsulosin 0.4mg capsules and Metoprolol Tartrate 200mg ER

Zydus Cadila (Healthcare) gets USFDA nod to market anti-epileptic drug to prevent & control seizures

AHMEDABAD-GANDHINAGAR | MUMBAI | RAJKOT – In a press-release submitted to the Indian Bourses on Monday, Ahmedabad headquartered pharma major – Cadila Healthcare Ltd (Dr Pankaj Patel led Zydus Cadila Group) has received the tentative approval from the USFDA to market Lacosamide Tablets (US RLD – Vimpat®) in the strengths of 50 mg, 100 mg,