Page 15 - Usfda

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 ..

Wockhardt likely to sell India business to cut debt, focus on UK: Analysts

Company left with low-margin brands in India after selling profitable ones

Aurobindo slips 6% in a week after arm receives EIR from USFDA

In the past six months, Aurobindo has underperformed the market by falling 31 per cent, as compared to a marginal 0.07 per cent decline in the S&P BSE Sensex.

Growth forecast in US market set to drive gains for Cipla stock

Street remains bullish on India prospects, regulatory headwinds for Goa site continue

Zydus Lifesciences US arm gets tentative USFDA nod for Sugammadex injection

Zydus Lifesciences Ltd on Friday said its US-arm has received tentative approval from the country's health regulator to market its generic version of Sugammadex injection. The injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. The tentative approval granted by the US Food and Drug Administration (USFDA) to Zydus Pharmaceuticals (USA) Inc is for Sugammadex Injection of strengths 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), single-dose vial, the company said in a regulatory filing. The drug will be manufactured at the group's injectables manufacturing facility at Jarod (Gujarat), India, it added. Sugammadex Injection had annual sales of USD 772 million in the US, the company said citing IQVIA MAT July 2022.

SEBI asks pharma companies to disclose details that can impact stock prices

The details that need to be disclosed are new drugs, pending patents, source of raw materials, and new partnerships, among others

USFDA asks Panacea Biotec to take corrective measures at Himachal unit

Panacea Biotec Ltd on Thursday said the US health regulator has asked for further corrective actions at the manufacturing unit of its wholly-owned arm at Baddi in Himachal Pradesh otherwise approval of any pending product applications from the facility may be withheld. The US Food and Drug Administration (USFDA) had inspected the Baddi unit of its subsidiary, Panacea Biotec Pharma Ltd (PBPL) from May 30 to June 8, 2022. Subsequently, the USFDA issued Form 483 with eight observations which are related to improvements in existing procedures and are addressable, Panacea Biotec said in a regulatory filing. According to the US Food and Drug Administration (USFDA), 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. The company said it has "now received a communication from the USFDA indicating the inspection classification .

US FDA issues 11 observations each for two sites in Bengaluru: Biocon

Biocon Ltd on Wednesday said the US health regulator has issued Form 483s with 11 observations each for two sites in Bengaluru and six observations for a plant in Malaysia, following inspection of seven manufacturing facilities of its arm Biocon Biologics. As per US Food and Drug Administration (USFDA), 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. The USFDA conducted three on-site inspections of Biocon Biologics' seven manufacturing facilities spanning two sites in Bengaluru, India and one at Johor, Malaysia, Biocon said in a regulatory filing. The inspections started with the Bengaluru site on August 11, 2022 and concluded with the Malaysia site on August 30, 2022, it added. "At the conclusion of these inspections, the agency has issued Form 483s with 11 observations each for the two sites in Bengaluru and six .

Zydus gets USFDA nod for generic version of Venlafaxine, Pregabalin

Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to market its generic version of venlafaxine extended-release tablets used to treat depression. The company also said the US Food and Drug Administration (USFDA) has granted final approval for pregabalin extended-release tablets used to treat pain caused by nerve damage due to diabetes or shingles (herpes zoster) infection. The approval granted by the USFDA for venlafaxine extended-release tablets is for strengths of 37.5 mg, 75 mg, 150 mg and 225 mg, Zydus Lifesciences said in a regulatory filing. Venlafaxine is used to treat depression, anxiety, panic attacks and social anxiety disorder. It had annual sales of USD 46 million in the US, the company said citing IQVIA MAT July 2022. Further, Zydus Lifesciences said the final approval granted by the USFDA to market pregabalin extended-release tablets is for strengths of 82.5 mg, 165 mg and 330 mg. The drug had annual sales of USD 3 ..