Last Updated : Monday, January 20, 2020 22:20:15

Tag Archives: US Food and Drugs Administration

USFDA clears STRIDES PHARMA’s Florida (US) facility, issues EIR

MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Mumbai headquartered pharmaceutical products manufacturing company Strides Pharma Science Ltd said of its Florida (US) based facility, having got cleared by USFDA (US Food and Drugs Administration) post inspection and the facility has got Establishment Inspection Report. The press-release titled,

India’s First New Discovery Antibiotics from WOCKHARDT gets Regulatory nod

MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Mumbai headquartered pharmaceuticals company Wockhardt Ltd said of having got Indian Regulatory approval for India’s first new discovery of antibiotics. The press-release titled, “India’s First New Discovery Antibiotics from Wockhardt Granted Indian Regulatory Approval”, enclosed with the regulatory filing as

ALEMBIC PHARMA gets USFDA nod to market opthalmic treatement

VADODARA (BARODA) | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Vadodara (Baroda) headquartered Indian Pharma company – Alembic Pharmaceuticals Ltd said of having got USFDA (US Food & Drugs Administration) nod to market ophthalmic treatment – Travoprost Opthalmic Solution USP, 0.004%. The approved abbreviated new drug application

Indian Marine Exports to remain Damp, says Drip Capital Report

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press-release shared by US based trade finance company Drip Capital Ltd regarding its report on outlook of Marine Exports, it said of the Indian Marine Exports primely to US and EU is expected to remain damp, primely due to stringent quality norms, consumer preference and anti-dumping duty

HIKAL’s Panoli (Gujarat) plant gets EIR, with zero observations

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered pharmaceutical company Hikal Ltd said of its Panoli (Gujarat) facility being inspected successfully by USFDA (US Food and Drugs Administration) and the facility has received establishment inspection report (EIR) with zero observations. In a filing as submitted

ALEMBIC PHARMA gets USFDA nod to sell medicine to cure Prostate Enlargement

VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Vadodara (Baroda) headquartered Alembic Pharmaceuticals Ltd said of having got nod to market medicines to treat prostate enlargement disease. In a press-release as submitted by the company to the Indian Bourses, titled – “Alembic Pharmaceuticals receives

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

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