Page 2 - Usfda

Regulators halt eye products' production at Global Pharma Healthcare site

Firm under US FDA scanner for bacterial contamination of its eye drops

How future with lower Covid death rate seems like a worthy investment

Unfortunately, turning nasal vaccines into reality has a long way to go. The same is true for any newer approach to combatting Covid

Alembic Pharmaceuticals gets USFDA nod to market generic cancer drug

The company's product is therapeutically equivalent to AstraZeneca UK's Calquence Capsules (100 mg)

Zydus gets USFDA nod to market generic medicine for treating depression

Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) in adults

USFDA pulls up Sun Pharma for manufacturing lapses in Halol plant

The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. "This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA stated. The health regulator inspected the manufacturing facility from April 26 to May 9, 2022. A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. In the letter to Mumbai-based company, the USFDA pointed out

Lupin gets US FDA nod for generic medicine to treat heart ailments

Pharmaceuticals firm Lupin Ltd on Tuesday said it has received approval from the US health regulator for its generic version of Prasugrel tablets. The medicine is indicated to prevent other serious heart and blood vessel problems in patients with recent heart attacks, strokes and blood clots in stents. The approval by the US Food and Drug Administration (US FDA) for the Abbreviated New Drug Application (ANDA) of Prasugrel tablets of strengths 5 mg and 10 mg, the company said in a regulatory filing. These are the generic equivalent of Effient tablets, 5 mg and 10 mg of Cosette Pharmaceuticals, Inc. "The product will be manufactured at Lupin's facility in Goa, India," it added. Prasugrel Tablets 5 mg and 10 mg had estimated annual sales of USD 18 million in the US, Lupin said citing IQVIA MAT September 2022 data.

Zydus Life gets final nod from USFDA for generic version of insomnia drug

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator to market its generic version of Triazolam tablets used on a short-term basis to treat insomnia. The approval granted by the US Food and Drug Administration (USFDA) is to market Triazolam tablets of strengths 0.125 mg and 0.25 mg, the company said in a regulatory filing. The medicine is used on a short-term basis to treat insomnia -- difficulty falling asleep or staying asleep. It works by slowing activity in the brain to allow sleep. It will be manufactured at the group's formulation manufacturing facility at Moraiya, Ahmedabad, the company said. Triazolam tablets had annual sales of USD 11.7 million in the US, the company said, citing IQVIA MAT September 2022 data.

Alembic Pharma gets USFDA nod for generic drug to treat breast cancer

Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for its generic Fulvestrant injection used in treatment of breast cancer. The approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA), Fulvestrant injection of strength 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, the company said in a statement. The approved injection is therapeutically equivalent to the reference listed drug product (RLD), Faslodex Injection, of AstraZeneca Pharmaceuticals LP, it added. Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of breast cancer, the company said. For 12 months ended September 2022, Fulvestrant injection, 250 mg/5 mL, had an estimated market size of USD 71 million, the company said citing IQVIA data.

USFDA issues warning letter to Glenmark Pharma for lapses at Goa plant

The US health regulator has pulled up drug maker Glenmark Pharmaceuticals for manufacturing lapses, including failure to establish required laboratory control mechanisms, at its Goa-based manufacturing plant. In a warning letter addressed to Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha, the US Food and Drug Administration (USFDA) pointed out various lapses at the company's Bardez-based facility in Goa, which produces drug formulations. The US Health regulator noted that the "warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals". It further said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated..." The USFDA inspected the manufacturing facility from May 12, 2022, to May 20, 2022. In the warning letter, the US health regulator pointed out the company's failure "to ...

Bajaj Healthcare completes USFDA pre-approval inspection of Vadodara plant

Bajaj Healthcare Ltd on Friday said it has successfully completed the US health regulator's pre-approval inspection of its active pharmaceutical ingredients facility located at Vadodara in Gujarat. The US Food and Drug Administration (USFDA) had conducted a pre-approval inspection of the facility from November 14, 2022, to November 17, 2022, Bajaj Healthcare Ltd (BHL) said in a regulatory filing. The pre-approval inspection of USFDA has completed successfully with zero Form 483 observations of the manufacturing facility, said the company, which is a manufacturer of APIs (active pharmaceutical ingredients), intermediates and formulations. Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator observes any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Aurobindo Pharma receives EIR from USFDA for its Andhra Pradesh facility

Aurobindo Pharma Ltd on Wednesday said it has received an Establishment Inspection Report (EIR) from the US health regulator for its manufacturing facility at Pydibhimavaram in Andhra Pradesh. The company's Unit XI at Pydibhimavaram is an API non-antibiotic manufacturing facility. It was inspected by the US Food and Drug Administration (USFDA) in February 2019 and issued a warning letter in June 2019. It was inspected further by the USFDA from July 25 to August 2, 2022 and issued a Form 483 with three observations. Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. "Subsequent to our responses for the aforesaid observations, we have received an EIR classifying the inspection as Voluntary Action Indicated (VAI) from the USFDA and with this, the inspection at our Unit XI is concluded," Aurobindo Pharma said in a ...

Alembic Pharma gets USFDA nod for generic cancer treatment medication

Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market Cyclophosphamide capsules, used in the treatment of different kinds of cancers, in the American market. The company has received approval from the US Food and Drug Administration (USFDA) to market its product which is a generic version of Hikma Pharmaceuticals USA Inc product, Alembic Pharmaceuticals said in a statement. Cyclophosphamide capsules is an alkylating drug indicated for the treatment of malignant disease and minimal change nephrotic syndrome in pediatric patients. According to IQVIA, cyclophosphamide capsules, 25 mg and 50 mg, have an estimated market size of USD 8 million in the US for twelve months ending Sep 2022. Shares of the drug firm were trading 1.32 per cent down at Rs 630.35 apiece on the BSE.

USFDA issues Form-483 with 3 observations to Alkem Lab's St Louis plant

Alkem Laboratories on Thursday said the US health regulator has issued three observations after inspecting its St Louis-based manufacturing facility. The US Food and Drug Administration (USFDA) had conducted a pre-approval inspection at the plant from October 31, 2022 to November 9, 2022, the drug firm said in a regulatory filing. At the end of the inspection, the company received Form 483 with three observations, it added. "There is no data integrity observation. This pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observations," the company said. As per USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Sun Pharma's Mohali plant in Punjab receives OAI status from USFDA

The plant was inspected in August and had received a form 483 with six observations earlier

Zydus Lifesciences gets USFDA's nod for generic hypertension drug

Zydus Lifesciences on Tuesday said it has received approval from the US health regulator to market blood pressure lowering drug Bisoprolol Fumarate and Hydrochlorothiazide tablets in the American market. The company has received approval from the US Food and Drug Administration (USFDA) to market the generic medication in multiple strengths, the Ahmedabad-based drug maker said in a statement. Bisoprolol Fumarate and hydrochlorothiazide combination is indicated to treat high blood pressure (hypertension). The drug will be manufactured at the company's formulation manufacturing facility at Ahmedabad SEZ, the company said. As per IQVIA MAT September 2022 data, Bisoprolol Fumarate and Hydrochlorothiazide tablets had annual sales of USD 27.1 million in the United States.

Zydus gets establishment inspection report from USFDA for Moraiya plant

Zydus Lifesciences on Monday said it has received an establishment inspection report from the US health regulator for its formulations manufacturing facility in Moraiya near Ahmedabad. The US Food and Drug Administration (USFDA) inspected the facility from July 26 to August 5, 2022, which concluded with four observations. "The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)," it added. The USFDA issues an establishment inspection report (EIR) to an establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection. Shares of Zydus Lifesciences were trading 2.51 per cent up at Rs 450.85 apiece on the BSE.

USFDA issues warning letter to Lupin for Maharashtra-based API plant

The US health regulator has pulled up drug maker Lupin for manufacturing lapses, including failure to establish adequate written procedures for cleaning equipment, at its Maharashtra-based plant. In a warning letter, the US Food and Drug Administration (USFDA) has pointed out various lapses at the Tarapur (Thane) plant which produces active pharmaceutical ingredients (API). "This warning letter summarises significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API)," the US health regulator said. It further said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API is adulterated..." The USFDA inspected the manufacturing facility from March 22 to April 4, 2022. A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. In the warning letter the health regulator pointed out the company

Glenmark Pharma gets US health regulator nod for generic medication

Glenmark Pharmaceuticals on Wednesday said it has received approval from the US health regulator to market Sodium Phenylbutyrate tablets, used in treating urea cycle disorders, in America. The company has received final approval from the US Food and Drug Administration (USFDA) for the product which is a generic version of Horizon Therapeutics' Buphenyl, the Mumbai-based drug maker said in a statement. According to IQVIA sales data for 12-month period ended September 2022, Buphenyl had annual sales of around USD 8.7 million. Glenmark's current portfolio consists of 177 products authorised for distribution in the US marketplace and 46 abbreviated new drug applications (ANDAs) pending approval with the USFDA.

USFDA issues import alert on Glenmark Pharma's Baddi manufacturing plant

Glenmark Pharmaceuticals on Wednesday said the US health regulator has put its manufacturing plant at Baddi under import alert. The drugs produced at the Baddi unit can now be detained without physical examination. The US Food and Drug Administration inspected the facility in June 2022 and subsequently placed it under "Official Action Indicated" status. The OAI classification implied that the USFDA may withhold approval of any pending product applications or supplements filed from such facility till the outstanding observations related to non-compliance with manufacturing norms laid down by the regulator. "We now wish to inform you that the US FDA has placed the Baddi (India) facility under import alert 66-40," Glenmark Pharmaceuticals said in a regulatory filing. As per the USFDA, import alert 66-40 implies detention without physical examination of drugs from firms which have not met drug GMPs. "The US revenues from products supplied from this facility contributed to 1-2 per cen

Dr Reddy's, Cipla, and Aurobindo units recall products in US market

Leading drug firms Dr Reddy's Laboratories, Cipla and Aurobindo Pharma are recalling different products in the US market for various issues, according to the US Food and Drug Administration. As per the enforcement report by the US Food and Drug Administration (USFDA), the US-based unit of Dr Reddy's Laboratories is recalling 2,838 ampules of vitamin K deficiency treatment drug Phytonadione Injectable Emulsion. According to the USFDA, Dr Reddy's Laboratories is recalling the affected lot due to "failed stability specifications". "Out of specification results reported at 12-month stability testing for aluminum content," it stated. Dr Reddy's initiated the Class III voluntary recall on September 14 this year. As per USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences". USFDA further said the US-based arm of domestic drug major Cipla is recalling 9,041 cartons of Arformoterol ..