Tag Archives: US Food and Drugs Administration

NATCO Pharma’s Vishakhapatnam Formulation facility kicks-off

HYDERABAD | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Hyderabad headquartered NATCO Pharma Ltd said of having commenced commercial manufacturing operations at company’s Vishakhapatnam formulation facility. In a press-release as submitted by the company to the Indian Bourses, titled – “Commercial Manufacturing Operations begin in NATCO’s

USFDA slams Form 483 to ALKEM LAB’s Daman plant, clears Baddi (HP) facility

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Exchanges, Mumbai headquartered pharma company Alkem Laboratories Ltd said of its Baddi (Himachal Pradesh) and Daman plants having inspected by USFDA (US Food and Drugs Administration) in month of August 2019, the regulators have given Establishment Inspection Report (EIR) to the

LUPIN gets USFDA nod to market medicine to cure Thyroid

BALTIMORE | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press-release submitted to the Indian Stock Exchanges by Lupin Ltd, the company said of having got approval from USFDA (US Food & Drugs Administration) to market medicine to cure thyroid and thyroid related diseases. The company release as submitted to the Indian Bourses read that,

INDOCO REMIDIES gets USFDA nod to market medicine to treat acidity

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Stock Exchanges, Mumbai headquartered pharma company Indoco Remedies Ltd said of having got approval from USFDA (US Food & Drugs Administration) to market medicine, to treat acidity and gastric secretions. The press-release as submitted by the company to the Indian Bourses,

LUPIN gets USFDA nod to market drug to treat THYROID

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered Lupin Ltd said of having got nod from US FDA (Food & Drugs Administration) to market drug to treat Thyroid and related disorders. In a press-release as submitted by the company to the Indian Bourses, titled –

LUPIN gets USFDA nod to market drug to treat Heart, Liver & Kidney disorders

BALTIMORE (US) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered pharma company Lupin Ltd said of having got USFDA nod to market drug to treat heart, liver and kidney related disorders. In a press-communication submitted to the Indian Bourses, titled – “Lupin receives U.S.

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

USFDA inspects Lupin Pharma’s Mumbai facility, slam 4 observations

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – USFDA (US Food & Drugs Administration) inspected the Mumbai facility of Lupin Pharma and has issued Establishment Inspection Report to the site & facility inspected.  The Regulators have also slammed 4 observations post inspecting the Lupin’s Mumbai facility In a regulatory filing submitted to the Indian Exchanges,  Pharma major

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

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

Sun Pharma Launches Ready-to-Infuse INFUGEM injection for cancer treatment

PRINCETON (NEW JERSEY, US) | VADODARA | MUMBAI | RAJKOT – In a press-release submitted to the Indian Exchanges on Monday, Indian Pharma sector major Sun Pharmaceutical Industries Ltd. today announced that INFUGEM™ (gemcitabine in sodium chloride injection), for intravenous use, is now commercially available in the U.S. INFUGEM, the first chemotherapy product that comes

Cipla’s Goa units gets EIR after being inspected by USFDA

MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses, pharma major Cipla Ltd said United States Food and Drug Administration (USFDA) at the Goa manufacturing facility from 21st – 28th January, 2019, the Company has received the Establishment Inspection Report (EIR), indicating closure of the inspection. For more details, please click the

USFDA concludes Cadila Healthcare’s (Zydus) Pharmez facility with one observation

AHMEDABAD | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses, on Wednesday, Ahmedabad headquartered Pharma major Cadila Healthcare (Dr Pankaj Patel led Zydus Cadila Group) Ltd said of one of their units being inspected by US Food & Drugs Administration (USFDA) and the regulator has concluded the inspection with one

USFDA cleared the Goa based sterile mfg site of Indoco Remedies

MUMBAI | RAJKOT – In a regulatory update submitted to the Stock Exchanges in India, Indoco Remedies Ltd said of US Food an Drug Administration (USFDA), having cleared the sterile manufacturing facility of the company, for Finished Dosages, located at Verna Industrial Area, Goa (Plant II). This i an outcome of the recent inspection conducted

Zydus Cadila gets USFDA nod, to market tablets, to treat high blood-pressure in lungs

AHMEDABAD | MUMBAI | RAJKOT – In a press-release submitted to the Indian Bourses, Ahmedabad headquartered pharma major – Cadila Healthcare Ltd (Dr Pankaj Patel owned Zydus Cadila Group) said of having received final approval from the US Food & Drugs Administration (USFDA) for Ambrisentan Tablets. The Company has received the final approval from the

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