New Delhi: Sun Pharma failed to properly clean and maintain equipment used for drug manufacturing at its Dadra-based manufacturing plant, according to the US Food and Drug Administration (USFDA).In a warning letter sent to the company's managing director Dilip Shanghvi on June 18, the US...
New Delhi, Sun Pharmaceutical Industries Ltd on Wednesday said it has received a warning letter from the US health regulator for its Dadra facility over violation of manufacturing norms.Sun Pharma said in a regulatory filing that the warning letter from the US Food and Drug Administration...
New Delhi: The US Food and Drug Administration (USFDA) has said that Sun Pharma and Dr. Reddy's Laboratories are recalling their products from the US market due to manufacturing issues.In its latest enforcement report, the US health regulator said a US-based unit of Sun Pharma is recalling...
According to the company, USFDA conducted the inspection at Unit III of Yugi Pharma Specialties located in Sangareddy district of Telangana from January 2 to February 2."Subsequently, the USFDA has determined the inspection classification status of this facility as an indication of official...
According to the latest enforcement report by the US Food and Drug Administration (USFDA), Dr. Reddy's Laboratories is recalling Zavigo (sapropterin dihydrochloride) Powder for Oral Solution (100 mg) due to it being a 'sub-potent drug'.Sapropterin dihydrochloride is used to treat...
New Delhi: Drug makers Dr Reddy's Laboratories, Sun Pharma and Aurobindo Pharm are recalling their products from the US market due to manufacturing issues, according to the latest enforcement report by the US Food and Drug Administration (USFDA).Dr. Reddy's Laboratories is recalling around...
New Delhi: Pharma major Cipla Ltd on Wednesday said it has received inspection observation in Form 483 from the US health regulator for its manufacturing facility in Kurkumbh, Maharashtra.According to the U.S. Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at...
New Delhi: According to the US health regulator, drugmakers Cipla and Glenmark are recalling their products from the US market due to manufacturing issues.Cipla's New Jersey-based subsidiary is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, according...
New Delhi: Natco Pharma failed to maintain cleanliness and sterilize equipment and utensils at appropriate intervals at its Telangana plant, according to the health regulator.In a warning letter to the company, the US Food and Drug Administration said investigators found various violations at...
New Delhi: The US health regulator has pulled up Kilich Healthcare India for manufacturing lapses, including packing of medicines in unhygienic conditions at its Maharashtra plant.In a warning letter to company managing director Paresh Mehta, the US Food and Drug Administration (USFDA) pointed...
New Delhi: Major generic drug makers Lupine, Glenmark and Natco Pharma are recalling their products from the US market due to manufacturing issues, according to the US health regulator.As per the latest enforcement report by the US Food and Drug Administration (USFDA), Lupine is recalling...
New Delhi, Natco Pharma on Tuesday said it has received a warning letter from the US health regulator for its Telangana-based manufacturing plant.The US Food and Drug Administration (USFDA) had issued eight observations under Form 483 after inspecting the company's Kothur-based formulation...