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DRUG MASTER FILE
Shocking claim: Ex-JPMorgan Chase banker Chirayu Rana accused of faking family tragedy in lawsuit against Lorna Hajdini — what we knowA former JPMorgan banker allegedly faked his father's death to take bereavement leave. Chirayu Rana then filed a lawsuit against executive ...
‘You will be found just like this guy’: Polymarket issues warning as US soldier arrested after winning $400K on Maduro raid betGannon Ken Van Dyke: A US Special Forces soldier was arrested for insider betting on a prediction market, earning over $400,000 by wagering...
Who is Jasveen Sangha? ‘Ketamine Queen’ to be sentenced in Matthew Perry caseJasveen Sangha, dubbed the 'Ketamine Queen', has apologized before her sentencing for supplying drugs that led to Matthew Perry's death. Sh...
Zydus Lifesciences gets 6 observations from USFDA for API plantThe US Food and Drug Administration (USFDA) conducted the inspection from December 14 to December 22, 2023. The inspection closed with six ...
Margin levels of our API to increase once we enter US biz: Amit Rajan, Bajaj HealthcareHowever, the pre-approved inspection has happened for one of the product where it will go to a big pharma para IV product and the supply wi...
Lupin gets warning letter from USFDA for Mandideep facilityShares of Lupin were trading 1.36 per cent lower at Rs 749.15 apiece on BSE.
Glenmark Pharma says USFDA has issued CRL for RyaltrisThe CRL cites deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in manufacturing faciliti...
Suven Life Sciences' Pashamylaram facility successfully completes USFDA inspectionThe facility has undergone renewal inspection from February 5-18 by the United States Food and Drug Administration (USFDA), Suven Life Scie...
Suven Life receives Establishment Inspection Report from USFDASuven Life Sciences said so far it has filed 19 DMF's and 4 ANDA's from its plant near Hyderabad which is FDA complaint.
Unichem Labs soars 8% as Q3 net up 10 foldsThe company had posted a profit of Rs 2.06 crore for the October-December quarter of the previous financial year, 2014-15.
Delhi HC turns down Bayer plea on stroke drug against Dr Reddy'sIn India, Bayer sells the product through its equal stake JV Bayer Zydus, formed with Ahmedabad-based Zydus Cadila.
Alembic Pharmaceuticals Q3 net up 7 per cent at Rs 70.66 croreIt had posted net profit of Rs 65.93 crore in the same quarter of the 2013-14 fiscal, Alembic Pharma said in a filing to the BSE.
'Indian companies to shell out Rs 30 lakh for generic drug fee'The Generic Drugs User Fee Act 2012 enables US Food and Drug Authority (USFDA) to charge a fee for registration of generic drugs.
- Cadila stock touches 52 week high after gettting USFDA approval for two generic drugs
According to pharma analyst, the company would continue to witness jump in its stock prices as it is bullish on getting FDA approval for it...
- Indian pharma companies like Hetero, Alembic, Lupin, Dr Reddy’s dominating US generic space
Drug companies from India filed 51% of the overall global applications, also called drug master filings (DMF), in the US market during cale...
- Parabolic Drugs Q2 net up 0.62 pc to Rs 14.38 crore
Parabolic Drugs today reported marginal increase in standalone net profit to Rs 14.38 crore for the quarter ended September 30, 2011.
- MSN Laboratories to foray into pain management market with launch of painkiller 'Tapentadol'
MSN Laboratories Limited, will foray into the pain management market with the launch of 'Tapentadol' a pain killer under brand name Tapal i...
- Suven Life Sciences manufacturing facility gets USFDA approval
Suven Life Sciences today said it has received the US health regulator''s approval for its active pharmaceutical ingredients.
- Ranbaxy ban to help Chinese companies
US Food and Drug Administration’s ban on seven API products of Ranbaxy may turn out to be a boon for the company’s Chinese peers, according...
- Cadila gets USFDA nod for its drug
Cadila Healthcare Ltd has received approval from the USFDA to market Meloxicam Tablets, which are used for treating pain and inflammation, ...