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FDA OBSERVATION
USFDA concludes inspection at Jubilant HollisterStier's Spokane plant with 8 observationsJubilant Pharmova announced its US subsidiary, Jubilant HollisterStier LLC, underwent a USFDA inspection. The facility in Spokane, Washingt...- Maharashtra FDA bars hospitals from forcing patients to buy medicines in-houseMaharashtra's Food and Drug Administration has issued a significant directive. Hospitals and medical practitioners must now allow patients ...
- 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 ...
- In 1987, ophthalmologist Dr. Jean Carruthers noticed her crossed-eye patients' frown lines were vanishing, and Botox accidentally became cosmetic history's biggest hitOriginally developed to address eye disorders such as blepharospasm, Botox has evolved into a key player in the cosmetic industry since its...
- 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...
- In the 1930s, rubber factory workers drank alcohol and suddenly felt sick. It wasn't just a workplace illness, it led to the discovery of Antabuse, helping millions quit drinkingAn accidental discovery in a rubber factory in the 1930s revealed that workers exposed to tetraethylthiuram disulfide experienced severe re...
- 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.
- 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...
- 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...
- Despite spending big on legal & professional consultants, FDA woes continue to haunt pharma companiesSun Pharma’s Halol plant received four observations three months after it received the clearance from the USFDA that had ended a two-year i...
- USFDA team finds 'female mosquito' in Aurobindo Pharma's facility during inspectionThe American health regulator has issued nine observations after inspecting the drug maker's Unit 4 formulation facility near Hyderabad in ...
- 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," ...
- 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...
- Natco takes a beating on FDA observation“The company believes there would be no adverse impact to its current or future pipeline products coming from these facilities,” Natco Phar...
- 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...
- USFDA red-flags lack of controls at Wockhardt's Shendra unit near AurangabadFDA had listed nine observations related to processes followed at the plant, which Wockhardt later clarified were not of a serious nature.
- FDA observations not to affect supply: LupinDrug major Lupin on Friday said supply of products manufactured at its Mandideep facility will not be affected despite the US Food and Drug...
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