Last Updated : Wednesday, April 1, 2020 20:20:37

News of Licenses | Approvals | Permissions in Gujarat

CADILA HEALTH gets USFDA nod to market tablets to treat Parkinson’s disease

AHMEDABAD / MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Ahmedabad headquartered Cadila Healthcare Ltd (Dr Pankaj Patel led Zydus Cadila Group) got USFDA (US Food and Drugs Administration) nod to market tablet to treat Parkinson’s disease or Parkinson’s like symptoms. In a company press-release titled, “Zydus receives

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

BLISS GVS PHARMA completes commissioning of Phase-1 @ Palghar facility

MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Mumbai headquartered pharmaceutical products manufacturing company Bliss GVS Pharma Ltd said of having completed commissioning and qualification of Phase-I of the multi-product manufacturing facility situated at Palghar in East Maharashtra. For LONG READ, please click / log on / visit

USFDA Accepts BLA for Mylan and Biocon’s Proposed Biosimilar for Review

BENGALURU / HERTFORDSHIRE (PITTSBURGH) / MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Bengaluru headquartered biotechnology company Biocon Ltd said of USFDA having accepted BLA (Biologics License Application) for a proposed biosimilar Bevacizumab, for review. For LONG READ, please click / log on / visit :- https://datelinegujarat.blogspot.com In

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

IRB MP Expressway SPV starts collecting toll on Mumbai Pune Corridor

MUMBAI / RAJKOT – In a regulatory filing as submitted to the Indian Stock Exchanges, Mumbai headquartered roads and highways construction company IRB Infrastructure Developers Ltd said of having started collecting toll on Mumbai-Pune corridor project w.e.f. 1st March, 2020, vide IRB MP Express Pvt Ltd, a special purpose vehicle company. For LONG READ, please

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

HAL gets modification document from DGCA, for Do-228 Civil Aircraft

LUCKNOW | BENGALURU | MUMBAI | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Bengaluru headquartered aeronautics arm of Indian Government and public sector undertaking company Hindustan Aeronautics Ltd said of having got modification document from Director General of Civil Aviation (DGCA) for Civil Aircraft Do-228, which is aimed to give

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

ZYDUS CADILA’s Diabetic treatment drug gets nod from Indian Drug Regulator

AHMEDABAD | MUMBAI | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Ahmedabad headquartered Dr Pankaj Patel led Zydus Group company Cadila Healthcare Ltd said of having got approval from Drug Controller General of India (DCDI) for Saroglitazar Magnesium for treatment of diabetes. To read more, please CLICK here. Long Read

CADILA inks licensing agreement to market Anemia treatment in China

AHMEDABAD | MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Ahmedabad headquartered pharmaceutical products manufacturing company Cadila Healthcare Ltd said of having entered into licensing agreement with China Medical System Holdings for marketing anemia treatment in Greater China. The press-release titled, “Zydus and China Medical System Holdings enter

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,

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