Last Updated : Thursday, January 16, 2020 14:25:28

Tag Archives: USFDA

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

STRIDES PHARMA gets USFDA nod to market nasal treatment drug

BANGALORE | MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Bangalore headquartered Strides Pharma Science Ltd said of having USFDA (US Food and Drugs Administration) nod to market nasal treatment drug – Loratadine OTC Softgel Capsules in 10 mg dosage value. The press-release titled, “Strides receives USFDA approval for Loratadine OTC Softgel Capsules”, enclosed with

ALEMBIC PHARMA gets USFDA nod to market anti-diabetic drug

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Vadodara headquartered Indian Pharmaceutical products manufacturing major – Alembic Pharmaceuticals Ltd said of having got tentative approval for marketing anti-diabetic drug – Empagliflozin Tablets in dosages of 10 mg (milligram) and 25 mg, primely aimed to substitute

ALEMBIC PHARMA gets USFDA nod to market anti-spasm drug

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Vadodara (Baroda) headquartered Indian pharmaceutical major – Alembic Pharmaceuticals Ltd said of having got approval to market anti-spasm (muscle contraction) drug. The release titled, “Alembic Pharmaceuticals announces USFDA Final Approval for Tizanidine Hydrochloride Capsules, 2 mg, 4

ALEMBIC PHARMA gets USFDA nod to market depressive disorder treatment

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Vadodara (Baroda) headquartered India pharmaceutical major – Alembic Pharmaceuticals receives USFDA Final Approval for drug Vilazodone Hydrochloride Tablets in 10 mg. 20 mg, and 40 mg dosage, which is used to treat depressive disorder and had a

US Regulators slam 3 observations to LUPIN’s Tarapur facility

MUMBAI | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered pharmaceuticals sector Indian Major Lupin Ltd said of its Tarapur facility being inspected by US regulators and the inspection has been closed with 3 observation, further the facility being classified under the OAI (Official Action Indicated) category. The filing

GLENMARK PHARMA gets USFDA nod to mkt tablets to treat excess iron

MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Indian Pharmaceutical company Glenmark Pharmaceuticals Ltd said of having got nod from USFDA (US Food and Drugs Administration) to market tablet to treat excess iron in the body, usually such iron overload is created due to blood transfusion in adults

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

Dr REDDY’s gets USFDA nod to market medicine to treat tumour

PRINCETON (NEW JERSEY – US) HYDERABAD | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Hyderabad headquartered pharmaceutical company Dr Reddy’s Laboratories Ltd said of having got USFDA (US Food & Drugs Administration) nod to market medicine to treat tumour for bone-marrow and cancer and has

STRIDE PHARMA gets USFDA nod to market pain-killer medicine

BANGALORE | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Bangalore headquartered pharmaceuticals company Strides Pharma Sciences Ltd said its Singapore based step-down subsidiary company Strides Pharma Global Pte. Ltd., Singapore of having got USFDA (US Food and Drugs Administration) approval to market pain-killer medicine –

ALEOR DERMA gets USFDA nod to market medicine to treat knee pain

VADODARA (BARODA) | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Vadodara (Baroda) headquartered pharmaceutical products manufacturing company Alembic Pharmaceuticals Ltd said of its joint-venture company Aleor Dermaceuticals having got USFDA nod to market medicine to treat knee pain. In a press-release as submitted by the company to the

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

INDOCO REMEDIES’ CRO – AnaCipher receives EIR from USFDA

HYDERABAD | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory updates submitted to the Indian Stock Exchanges, Hyderabad headquartered Indoco Remedies Ltd’s Clinical Research Organization (CRO) has been inspected by USFDA (US Food and Drugs Administration) and cleared being granted Establishment Inspection Report (EIR). In a press-release as submitted by the company to the

GLENMARK PHARMA gets USFDA nod to market medicine to treat obesity

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered Glenmark Pharmaceuticals Ltd said of having received USFDA (US Food and Drugs Administration) nod to market medicine to treat obesity and overweight related disorders. In a company press-release as submitted to the Indian Bourses, titled – “Glenmark

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