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kilitch healthcare: USFDA issues warning letter to Kilitch Healthcare for Navi-Mumbai plant

The US Food and Drug Administration (USFDA) has issued a warning letter to Kilitch Healthcare India for manufacturing lapses at its plant in Maharashtra. The letter highlights various violations of current good manufacturing practice (CGMP) regulations, including packing drugs in insanitary conditions and failing to establish proper procedures to prevent contamination. The USFDA observed that the facility was poorly cleaned and maintained, posing risks of contamination. Kilitch Healthcare has committed to suspending production of all drugs for the US market. The company must address the violations and provide a plan for corrective action.

Mumbai , Maharashtra , India , Paresh-mehta , Drug-administration , Kilitch-healthcare-india , Managing-director-paresh-mehta , Kilitch-healthcare , Usfda , Cgmp , Us-food-and-drug-administration , Fda

USFDA issues warning letter to Kilitch Healthcare for Navi-Mumbai plant

USFDA issues warning letter to Kilitch Healthcare for Navi-Mumbai plant
moneycontrol.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from moneycontrol.com Daily Mail and Mail on Sunday newspapers.

Maharashtra , India , Mumbai , Paresh-mehta , Drug-administration , Managing-director-paresh-mehta , Kilitch-healthcare-india , Kilitch-healthcare , Usfda , Warning-letter , Ilitch-healthcare , Avi-mumbai-plant

Glenmark, Lupin recalling drugs in American market: USFDA

US News: Lupin, Glenmark, Natco Pharma recall various drugs in the US due to manufacturing issues. USFDA initiates recalls for health risks. India maintains a

United-states , Aurangabad , Maharashtra , India , American , Natco-pharma , Glenmark-pharmaceuticals-inc , Us-food-drug-administration , Lupin-pharmaceuticals , Drug-administration , Rifampin-capsules , Baltimore-based-lupin

Natco Pharma gets warning letter from USFDA for Telangana plant

The US Food and Drug Administration (USFDA) had issued eight observations under Form 483 after inspecting the company's Kothur-based formulation facility.

Kothur , Karnataka , India , Telangana , Andhra-pradesh , Natco-pharma , Drug-administration , Business , Companies , Usfda ,

Natco Pharma news: Natco Pharma gets warning letter from USFDA for Telangana plant

Natco Pharma, a pharmaceutical company, received a warning letter from the USFDA regarding its manufacturing plant in Telangana. This came after the FDA conducted an inspection of the company's facility in Kothur last October, issuing eight observations under Form 483.

Telangana , Andhra-pradesh , India , Kothur , Karnataka , Natco-pharma , Drug-administration , Natco-pharma-news , Usfda , Us-food-and-drug-administration ,

Piramal Alternatives invests Rs 110 crore in Biodeal Pharmaceuticals

Piramal Alternatives invested Rs 110 crore in Noida-based Biodeal Pharmaceuticals through convertible instruments. The funding will enhance infrastructure, technology, and a nutraceuticals manufacturing facility. Biodeal is a key contract manufacturing player, specializing in nasal sprays and achieving PIC/S approval.

India , Anurag-kumar , Kalpesh-kikani , Biodeal-pharmaceuticals , Piramal-group , Credit-fund , Piramal-enterprises-etmarkets , Piramal-enterprises , Noida-based-biodeal-pharmaceuticals , Performing-credit , Inspection-co-operation-scheme , Piramal-alternatives

breast cancer: Gland Pharma gets USFDA nod for generic breast cancer drug

Gland Pharma has received approval from the USFDA to market a generic medication for breast cancer treatment, Eribulin Mesylate Injection. It's expected to be the first generic approval in the market, with sales of around USD 92 million in the US.

Drug-administration , Orbicular-pharmaceutical-technologies-pvt-ltd , Gland-pharma , Eribulin-mesylate-injection , Orbicular-pharmaceutical-technologies-pvt , Breast-cancer , Usfda , Us-food-and-drug-administration , Iqvia ,

National News: Ocugen files Covaxin IND application with USFDA, seeks nod for Phase-3 trial in US | India News – Rashtra News

Ocugen files Covaxin IND application with USFDA, seeks nod for Phase-3 trial in US | India News - Rashtra News : Rashtra News #Ocugen #files #Covaxin #IND #application #USFDA #seeks #nod #Phase3 #trial #India #News #Times #India HYDERABAD: Ocugen Inc, Bharat Biotech’s US and Canada partner for indigenously developed Covid-19 vaccine Covaxin, has submitted an

India , United-states , Hyderabad , Andhra-pradesh , Canada , Bharat , American , Shankar-musunuri , Ocugen-inc , Drug-administration , India-news , Rashtra-news

How a 12th fail teen turned Hyderabad's richest bizman | Hyderabad News

Dr Murali Krishna Prasad Divi's resilience and strategic decisions have propelled Divi’s Labs to global success as a top API manufacturer. The company

Nalgonda , Andhra-pradesh , India , Machilipatnam , Hindustan , India-general- , Hyderabad , Visakhapatnam , Murali-krishna-prasad , Divi-lab , Indian-drugs-pharmaceuticals-ltd , Us-food-drug-administration

Aurobindo to resume production at aseptic lines of Eugia Pharma's Unit-III

India Business News: Aurobindo Pharma plans to resume commercial production at Eugia Pharma's Pashamylaram formulations facility in Hyderabad. Distribution of aseptic prod

Tirupati , Andhra-pradesh , India , Hyderabad , Aurobindo-pharma , Eugia-pharma-pashamylaram , Tenofovir-disoproxil-fumarate , World-health-organisation , Eugia-pharma-specialities-ltd , Healthcare-ltd , Us-food-drug-administration , Eugia-pharma-specialities