Last Updated : Wednesday, April 1, 2020 20:03:16

Tag Archives: USFDA

USFDA inspects Biocon’s Malaysian facility, issues EIR with VAI classification

BANGALORE / MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Bengaluru headquartered Indian bio-technology company Biocon Ltd said of having got Establishment Inspection Report (EIR) with Voluntary Action Initiated (VAI) for the company’s Malaysian facility, engaged in manufacturing insulin. The company statement attributed to the company spokesperson, titled,

STRIDE PHARMA’s Banglore facility gets EIR

BANGALORE / MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Bangalore headquartered Stride Pharma Science Ltd said of having got Establishment Inspection Report (EIR) for their Bangalore facility after the facility was inspected by USFDA (US Food and Drugs Administration) in the month of January 2020, for specific

GLENMARK PHARMA gets USFDA nod to market for oral diabetic medicine

MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Mumbai headquartered pharmaceutical products manufacturing company Glenmark Pharmaceuticals Ltd said of having got tentative approval from USFDA (US Food and Drugs Administration) to sell and market treatment to cure diabetic in form of oral diabetic medicine – Dapagliflozin Tablets, in

Dr REDDY’s LAB launches injection to treat narcotic overdose

HYDERABAD / PRINCETON (NEW JERSEY – US) / MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Hyderabad headquartered Indian Pharmaceutical products manufacturing company Dr Reddy’s Laboratories Ltd said of having announced first-to-market launch of Naloxone Hydrochloride Injection USP in 2 mg (milligram) / 2 ml (milliliter) dosage value,

Dr REDDY’s LAB gets USFDA nod to market injection to treat severe agitation in patients with schizophrenia

HYDERABAD / PRINCETON / MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Hyderabad headquartered pharmaceutical products manufacturing company Dr Reddy’s Laboratories Ltd said of having got nod from USFDA (US Food and Drugs Administration) to sell injection in US Market to treat severe agitation in patients with schizophrenia, the

GRANULES INDIA gets USFDA nod to sell drug to treat potassium deficiency

HYDERABAD / MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Hyderabad headquartered pharmaceutical products manufacturing company Granules India Ltd said of having got USFDA nod to market drug to treat potassium deficiency – Potassium Chloride Extended – Release Tablets USP in dosage value of 600 mg (milligram) and

STRIDES PHARMA gets USFDA nod to market anti-bacterial treatment

BANGALORE / MUMBAI – In a regulatory update submitted to the Indian Stock Exchanges, Bangalore headquartered Strides Pharma Science Ltd said of having got nod from USFDA (US Food and Drugs Administration) to market anti-bacterial treatment drug Tetracycline Hydrochloride Capsules in 250 mg (milligram) and 500 mg dosage. For LONG READ, please click / log

USFDA inspection @ AUROBINDO PHARMA’s Unit IV continues …

HYDERABAD | MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Hyderabad headquartered Aurobindo Pharma Ltd said of the USFDA inspection still open and under review of the company’s Unit IV, as per the communication received from the US Food and Drugs Administration, as per the previous communication, the

STRIDES PHARMA to acquire 18 ANDAs from Pharmaceutics International, Inc.

BENGALURU | MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Bengaluru headquartered Indian Pharmaceutical products manufacturing company Strides Pharma Science Ltd said of having acquired 18 abbreviated new drug applications (ANDA) from Pharmaceutics International, Inc., for a transaction value of approximately US Dollars $6.1 million, of which US

GRANULES INDIA gets USFDA nod to market tablets to treat joint pains and fever

HYDERABAD | MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Hyderabad (Telangana) headquartered Indian Pharmaceuticals company Granules India Ltd said of USFDA having got approval from USFDA (US Food and Drugs Administration) to market tablets to treat joint pains and fever. For LONG READ click / log on

LUPIN gets USFDA nod to market tablets to treat leg joint pain

MUMBAI | BALTIMORE | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Mumbai headquartered pharmaceutical products manufacturing company Lupin Ltd said of having got approval to market drug to treat Active Rheumatoid Arthritis (leg joint pain) and the product which has annual sales of US Dollar $44 million equivalent in

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

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

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