Page 33 - Usfda
HCG becomes first hospital in India to digitise histopathology diagnosis
Digital diagnosis is now the default diagnosis of the lab for surgical pathology and 100% of FFPE slides are digitally scanned into high-resolution digital images
 "HCG becomes first hospital in India to digitise histopathology diagnosis")
Expansions, clean track record helping Divi's Labs tap new opportunities
The current margin pressure will also get mitigated by tax benefits and operational efficiencies
 "Expansions, clean track record helping Divi's Labs tap new opportunities")
Biocon, Mylan get USFDA nod for pegfilgrastim from new Bengaluru facility
Biocon Biologics, through its partner Mylan, has commercialised three of its co-developed biosimilars in developed markets like the US, Canada, the European Union and Australia.
 "Biocon, Mylan get USFDA nod for pegfilgrastim from new Bengaluru facility")
US FDA pulls up Ipca Labs for manufacturing violations at Gujarat plant
The United States Food and Drug Administration (USFDA) inspection of its Piparia (Silvassa) formulations manufacturing unit in August resulted in three observations, it added.
 "US FDA pulls up Ipca Labs for manufacturing violations at Gujarat plant")
USFDA red flags Torrent Pharma's US-based arm for manufacturing violations
The plant's water system was not adequately designed, controlled, maintained, and monitored to ensure it consistently produced water that met specifications and appropriate microbial limits
 "USFDA red flags Torrent Pharma's US-based arm for manufacturing violations")
Indian pharma cos with bigger US presence face more FDA scrutiny: Analysts
Big entities such as Aurobindo and Dr Reddy's have been currently filing for new product approvals from multiple sites
 "Indian pharma cos with bigger US presence face more FDA scrutiny: Analysts")
USFDA observes major protocol lapses in Aurobindo's sterile drug unit
Regulator issues Form 483 with as many as 14 observations that could impact ongoing operations at the plant
 "USFDA observes major protocol lapses in Aurobindo's sterile drug unit")
Exposure to US market causing constant FDA scrutiny for big drug firms
Dr Reddy's was in the news for falling short of expectations during routine audits conducted by the US drug regulator
 "Exposure to US market causing constant FDA scrutiny for big drug firms")
Lupin launches generic drug in US for treatment, prevention of hypokalemia
The company had earlier received approval for the product from the United States Food and Drug Administration
 "Lupin launches generic drug in US for treatment, prevention of hypokalemia")
Zydus Cadila gets tentative USFDA approval to market arthritis drug
The tablets will be manufactured at the group's manufacturing facility at SEZ, Ahmedabad, Zydus Cadila said.
 "Zydus Cadila gets tentative USFDA approval to market arthritis drug")
Aurobindo Pharma gets 14 observations from the USFDA for Hyderabad plant
The observations issued by the USFDA notifies the company's management of objectionable conditions at the inspected facility
 "Aurobindo Pharma gets 14 observations from the USFDA for Hyderabad plant")
Aurobindo Hyderabad plant in regulatory trouble, share price falls 8%
The US Food and Drug Administration issued Form 483 with 14 observations to the company following the completion of inspection from November 4-14.
Lupin's prophylaxis and chronic asthma treatment drug gets USFDA nod
The medicine is indicated for prophylaxis and treatment of chronic asthma in adults and children 12 years of age and older, it added.
 "Lupin's prophylaxis and chronic asthma treatment drug gets USFDA nod")
Aurobindo Pharma receives 8 US FDA observations for two of its facilities
Observations are related to procedural improvements, not data integrity, says the company
New FDA warning letters show Indian drug makers' quality concerns persist
The latest regulatory crackdown shows US regulator's stance is hardening toward lapses in quality control even as it seeks cheaper drugs to contain health care costs
 "New FDA warning letters show Indian drug makers' quality concerns persist")
Zydus Cadila receives USFDA warning letter for its Moraiya facility
The company remains committed to patient safety and meeting the expectations of regulatory compliances, the Gujarat-based firm said.
 "Zydus Cadila receives USFDA warning letter for its Moraiya facility")
Strides Pharma Science may resume Ranitidine drug sale in US market
Strides' Ranitidine tablets 300 mg is within the acceptable limits for N-nitrosodimethylamine (NDMA) of 96 nanograms per day or 0.32 ppm
Cadila Healthcare dips 8% as USFDA issues warning letter for Moraiya plant
The company said the warning letter does not affect the existing business of the company in the US and the existing product supplies from the Moraiya facility will continue.
 "Cadila Healthcare dips 8% as USFDA issues warning letter for Moraiya plant")
Ranitidine recall causes Rs 40-crore dent in Dr Reddy's provisioning
An amount of Rs 17 crore is recognised as a possible refund liability (as a reduction from revenue) arising out of the company's decision to recall the said product
 "Ranitidine recall causes Rs 40-crore dent in Dr Reddy's provisioning")
USFDA issues warning letter for Cadila Healthcare's Moraiya facility
The formulation unit 45% of the firm's US sales; Cadila says letter does not impact its existing business in the United States for now