Searched for
US FDA OBSERVATIONS
Dabur India shares in focus after US FDA places drugs from Silvassa plant under import alert. Here’s whyDabur India shares are set to be in focus after the US FDA issued an import alert on drugs manufactured at its Silvassa plant, citing data ...- Trump tariffs changed taste of foods in U.S? Label checking reveals shocking detailsTrump Tariffs have grabbed headlines and become the topic of discussion around the world. Now there is a reality-check on the food ingredie...
- More macro headwinds on the cards? Tackle them with core principles: 6 pharma stocks with upside potential of up to 28%There was a time when the Indian pharma story in the US was almost entirely about inspection risk. The US FDA would inspect a plant, a warn...
- U.S. drug regulator flags data integrity, maintenance lapses at Dabur India plantThe U.S. FDA has identified significant data integrity and manufacturing lapses at a Dabur India plant following a January inspection. Find...
- Compliance squeeze, global scrutiny redefine India’s $30 billion pharma export playbookAs global markets prioritise quality and regulatory trust, India’s pharma sector is recalibrating beyond its traditional cost advantage.
- Social media is abuzz with weight-loss drug retatrutide and longevity goals. What is the drug all about?A new weight-loss drug, retatrutide, is generating excitement. This investigational medicine targets three hormone receptors, offering a po...
- Drugmaker Granules to tighten oversight after US FDA warning, executive saysThe company, which is globally one of the largest paracetamol makers and a major player in the active pharmaceutical ingredients market, de...
- Indian drugmaker Granules to tighten oversight after US FDA warning, exec saysAmid growing scrutiny from the U.S. FDA over documentation practices and contamination issues, Granules India is reinforcing its manufactur...
- No observations by US FDA during plant inspection: DRLDr. Reddy's Laboratories announced that the U.S. Food & Drug Administration (FDA) completed a routine Good Manufacturing Practice (GMP) ins...
- US FDA issues Form 483 with 10 observations to Sun Pharma’s Halol unitListed pharmaceutical entity Sun Pharmaceutical Industries on Tuesday informed the exchanges that the US FDA has issued Form 483 with ten o...
- Understanding US FDA inspection: How investors and management can avoid heartburnWith India playing a significant role in the global pharmaceutical sector, one may wonder about the quality control practices adopted in th...
- It is too premature to take a call on Aurobindo Pharma: Kunal Dhamesha, SBICAP SecuritiesThe injectables plant is important from their future growth as well as current revenue perspective.
- Sun Pharma receives 483 for Baska facility, co says responded to USFDAAt the conclusion of the inspection, the US FDA issued a Form 483, with one observation for which the Company has submitted the response to...
- Dr Reddy’s heading for big trouble: Amit Rajan, Celogen Life SciencesThere are multiple problems ahead of Dr Reddy’s in coming days, says Rajan.
- Strides Shasun gets 3 observations from USFDA for Bangalore plant"The formulations facility in Bangalore was recently inspected by the US FDA. The company has been issued a Form 483 with 3 observations," ...
- 2017 onward we are getting a lot of good news in the Pharma industry: Gurudatta G G, Estima PharmaSun Pharma's Mohali plant import alert has been lifted after approximately three and a half years whereas Halol plant has recently been aud...
- Data on US FDA observations on Indian firms disturbing: EdelweissSince the Generic Drug User Fee Amendments implementation in Oct 2012, FDA inspections have doubled in India and China, which led to consid...
- US FDA issues seven observations on Sun Pharma's Mohali siteThe FDA said there was no password protection and noted, "Laboratory analysts have the ability to change instrument settings including date...
- Lupin shares fall may be overdone as review minorBut a closer reading of the FDA observations show that they could be of a minor nature and may not lead to any significant impact on earnin...
- Lupin’s MP plant under USFDA scannerThe US Food and Drug Administration (USFDA) has found 15 manufacturing deficiencies at one of Lupin’s plant in Madhya Pradesh (MP) during t...
Load More
