Page 14 - Usfda

Nifty Pharma dips to 7-mth low; bears may gain control if breaks 52-wk low

Barring Sun Pharmaceutical Industries, which is anticipated to rally up to 10 per cent; other stocks indicate weak bias, as per technical charts

Cipla shares fall over 6% after its unit gets 8 observations from USFDA

Shares of Cipla on Monday ended over 6 per cent lower after the company received 'Form 483' with eight observations for its Pithampur-based manufacturing facility. The stock declined 6.02 per cent to settle at Rs 964.05 apiece on the BSE. During the day, it tumbled 6.78 per cent to Rs 956.20. On the NSE, it tanked 6.11 per cent to end at Rs 963 per share. In volume terms, 2.38 lakh shares were traded on the BSE and over 58.29 lakh shares on the NSE during the day. The US Food and Drug Administration (USFDA) conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility from February 6-17, the Mumbai-based drug firm said in a regulatory filing on Saturday. On conclusion of the inspection, the company has received eight inspectional observations in Form 483, it added. The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time, it said. As per USFDA, Form 483 is issued to a firm's managemen

Drug firm Glenmark gets USFDA nod for generic diabetes drug to market in US

Drug firm Glenmark said it has received approval from the US health regulator to market a generic medication to treat diabetes in the American market. Glenmark Pharmaceuticals Inc, USA, a unit of the company, has received tentative approval from the US Food & Drug Administration (US FDA) for Saxagliptin Tablets in strengths of 2.5 mg and 5 mg, the Mumbai-based drug maker said in a statement. The company's product is the generic version of AstraZeneca AB's Onglyza tablets (2.5 mg and 5 mg), it added. According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza tablets (2.5 mg and 5 mg) achieved annual sales of around USD 122.3 million. Glenmark said its current portfolio consists of 179 products authorised for distribution in the US marketplace. The drug firm has 46 abbreviated new drug applications (ANDAs) pending approval with the USFDA, it added. In addition to these internal filings, Glenmark continues to identify and explore external development ...

Natco Pharma jumps 4% on filing generic version of oncology drug in US

The drug major filed an abbreviated new drug application (ANDA) for generic versions of Olaparib tablets - 100 mg and 150 mg with the US Food and Drug Administration (USFDA)

Sun Pharma gets US health regulator nod to market generic medication

Sun Pharmaceutical Industries on Friday said its subsidiary has received approval from the US health regulator to market a generic medication used in the treatment of multiple myeloma. The company has received final approval from the US Food and Drug Administration (USFDA) for the generic lenalidomide capsules in multiple strengths, Sun Pharma said in a statement. In June 2021, Sun Pharma entered into a settlement with Celgene Corporation (Celgene) to resolve the patent litigation regarding its generic lenalidomide capsules. Under the terms of this settlement, Celgene granted Sun Pharma a license to patents required to manufacture and sell certain limited quantities of generic lenalidomide capsules in the US, beginning sometime after March 2022. In addition, the license allows Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026. Shares of Sun Pharma were trading 0.48 per cent down at Rs 1,002 apiece on the

Lupin bags gets approval from USFDA to market generic product in America

Drug maker Lupin on Thursday said it has received approval from the US health regulator to market a generic medication, used before a surgery to decrease the volume of secretions from mouth, lungs and stomach, in the American market. The company has received approval from the US Food and Drug Administration (USFDA) for Glycopyrrolate Injection, a generic equivalent of Hikma Pharmaceuticals' Robinul Injection, the Mumbai-based drug maker said in a statement. The product marks the first approval from the company's new injectable facility in Nagpur, it added. "We are committed to building a strong injectable business as part of our growth strategy," Lupin CEO Vinita Gupta said. With the approval of the product from the Nagpur facility, the company can now fast-track its injectable portfolio rollout and build on R&D capabilities in complex products, she added. The approval for Glycopyrrolate clears the path for more internally manufactured injectable products, Gupta stated. As per ..

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