Search For "usfda"
Zydus receives final approval from USFDA to market drug used to relieve ch
Updated : 4 years ago IST
New Delhi [India], March 9 (ANI): Zydus Lifesciences Ltd. has received final approval from the United States Food and Drug Administration (USFDA) to market Nitroglycerin Sublingual tablets used to relieve chest pain in people who have certain heart conditions, said the pharmaceutical company
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UAE based Niner pharmaceutical plans manufacturing facilities in India
Updated : 4 years, 1 month ago IST
Dubai [UAE], January 28 (ANI/Heylin Spark): Niner Pharmaceuticals LLC led by Mr Balaji is a pharmaceutical company headquartered in Dubai. With a vision to provide world-class pharmaceutical products to meet the needs of end consumers, Niner Pharmaceuticals LLC manufactures and supplies qual
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Aragen acquires Intox Pvt. Ltd.
Updated : 4 years, 2 months ago IST
Hyderabad (Telangana)/ Pune (Maharashtra) [India], December 15 (ANI/BusinessWire India): Aragen Life Sciences, a global research, development, and manufacturing solutions provider (CRO/CDMO), announced that it has signed a definitive agreement to acquire Pune-based Intox Pvt. Ltd.
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Zydus Cadila receives final approval from USFDA for Glycopyrrolate injecti
Updated : 4 years, 4 months ago IST
Ahmedabad (Gujarat) [India], November 10 (ANI): India-based pharma giant, Zydus Cadila received final approval from USFDA for Glycopyrrolate injection that is used before surgery to decrease the volume of secretions from the mouth, lungs and stomach.
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Granules India subsidiary clears USFDA audit
Updated : 4 years, 7 months ago IST
Hyderabad (Telangana) [India], July 21 (ANI): The drug maker Granules India on Wednesday announced that its US-based subsidiary cleared a pre-approval inspection (PAI) audit by the US drug regulator.
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Top drug regulator suspends import license of 19 firms for their COVID-19
Updated : 5 years, 7 months ago IST
New Delhi [India], July 25 (ANI): The Central Drugs Standard Control Organisation (CDSCO) has suspended the import licenses of at least 19 firms for their respective COVID-19 test kits after USFDA removed the manufacturer from their list of the product of serology test kits for coronavirus.
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Remdesivir included in 'investigational therapy' for restricted emergency
Updated : 5 years, 9 months ago IST
New Delhi [India], June 14 (ANI): Union Health Ministry on Sunday said that drug Remdesivir has been included as an "investigational therapy" only for restricted emergency use on COVID-19 patients.
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Dr Reddy's Labs in licensing pact with Gilead Sciences for Remdesivir
Updated : 5 years, 9 months ago IST
Hyderabad (Telangana) [India], June 13 (ANI): Dr Reddy's Laboratories said on Saturday it has entered into a non-exclusive licensing agreement with Gilead Sciences Inc that will grant Dr Reddy's the right to register, manufacture and sell Gilead's investigational drug Remdesivir, a potent
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AIIMS Rishikesh partners with Stasis to launch remote monitored COVID-19 i
Updated : 5 years, 9 months ago IST
Bengaluru (Karnataka) [India] May 28 (ANI/PRNewswire): All India Institute of Medical Sciences (AIIMS), Rishikesh has teamed up with Stasis, a Bengaluru-based start-up, to implement a remote patient monitoring solution to manage COVID-19 suspects/patients in isolation wards.
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Centaur Pharma's API Ambernath facility receives EIR from USFDA
Updated : 6 years, 3 months ago IST
Mumbai (Maharashtra) [India], Nov 27 (ANI/NewsVoir): Centaur Pharmaceuticals' state-of-the-art API Ambernath facility was audited by the USFDA and a 483 form was issued with one observation which was responded to, immediately.
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Margin pressure to persist for pharma companies: ICRA
Updated : 6 years, 5 months ago IST
New Delhi [India], Oct 5 (ANI): The growth and profitability of Indian pharmaceutical companies in current financial year will be constrained by regulatory interventions like price controls in domestic market and compulsory genericisation in overseas market, according to ICRA Ratings.
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Strides Pharma acquires manufacturing facility from US-based Micelle BioPh
Updated : 6 years, 6 months ago IST
Bengaluru (Karnataka) [India], Aug 27 (ANI): Strides Pharma Science Ltd said on Tuesday that its step-down subsidiary Strides Pharma Inc has acquired a manufacturing facility in Florida from Micelle BioPharma Inc.
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