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Jubilant Life Sciences in plans to split pharma and life science ingredient businesses | Pharma News | Pharma Udyog
Noida-based Jubilant Life Sciences Ltd plans to demerge its pharmaceuticals and life science ingredient businesses as part of its second phase of r…
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Pfizer
Pfizer in talks to merge off its patent drugs business with Mylan | Pharma News | Pharma Udyog
Bengaluru: Pfizer Inc is in talks to merge its off-patent drugs business with Mylan NV in a stock deal, the Wall Street Journal reported on Sat…
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FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis | Pharma News | FDA
On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the h…
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USFDA retains OAI status for Indoco's Goa plant | Pharma News | FDA
As per the USFDA, observations have been made after inspection of a facility in response to Form 483. An FDA Form 483 notifies the company's man…
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Dr Reddy's launches erectile dysfunction treatment drug in US
Dr Reddy's Laboratories on Wednesday announced launch of Tadalafil tablets, used to treat erectile dysfunction, in the US market. The appro…
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Sun Pharma
Sun Pharma gets one 483 for Baska facility, Company says responded to FDA
MUMBAI: India's largest drug maker Sun Pharma on Monday said that it has received letter 483 (an observation of deviation in manufacturing pr…
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Sun Pharma
Sun Pharma auditor files case against Macquarie with Economic Offences Wing
The Mumbai Police's Economic Offences Wing (EOW) has initiated an inquiry against Macquarie broking house on the basis of complaint registere…
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News
Drug regulator tells Johnson & Johnson to Pay Rs 74.5 lakh to patient with ‘faulty’ hip implant
Johnson & Johnson had marketed the ASR (articular surface replacement) implants in India through its subsidiary DePuy between 2004 and 2010. …
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News
Dr Reddy's gains 2% as USFDA completes audit of US plant with zero Form.483 observations
Share price of Dr Reddy's Laboratories gained more than 2 percent intraday Friday after company received zero observations for its plant. …
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USFDA lifts warning on Dr Reddy's Duvvada unit, relief after Bachupally formulation Unit observations
Duvvada resolution is expected to give a huge fillip to the company, as around 20% of its future ANDA (abbreviated new drug applications) filings w…
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News
Update about ICH guidelines on Continuous manufacturing of Pharmaceutical products | Pharma Udyog
Update about ICH guidelines on Continuous Manufacturing In June 2018 already, the International Council for Harmonisation (ICH) announced the c…
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News
Data integrity : Compliance - GMP and FDA Requirements | 21 CFR Part 11 | Pharma Udyog
Data integrity is an old concept made essential in today’s digital age, and means data that is accurate, complete, and repeatable, which in turn en…
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Sun Pharma
Sun Pharma Biggest recall | The administration of a glass particulate
Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of …
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