Last Updated : Wednesday, April 1, 2020 13:47:02

Tag Archives: US Food and Drugs Administration

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

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

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

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

Do NOT follow this link or you will be banned from the site!