Page 5 - Usfda

Granules down 7% after USFDA issues warning letter or Gagillapur facility

"On February 26, 2025, the US FDA issued a Warning Letter to Granules' Gagillapur facility based on its inspection conducted in August 2024," the filing read

Indian pharma sector's regulatory violation instances fell 11% in '24

In 2014, the share of OAI status globally stood at 6 per cent which has now more than doubled standing at 14 per cent

USFDA pulls up Jagsonpal Pharma for manufacturing lapses at API plant

The US health regulator has pulled up Jagsonpal Pharmaceuticals for significant manufacturing lapses at its Rajasthan-based active pharmaceutical ingredients (APIs) plant. In a warning letter issued to the company's Managing Director Manish Gupta, the US Food and Drug Administration (USFDA) noted that the correspondence summarizes significant deviations from Current Good Manufacturing Practice for APIs. The US health regulator stated that it inspected the company's Bhiwadi- based plant in Rajasthan on March 20, March 27, and April 3, 2024. "This warning letter summarises significant deviations from Current Good Manufacturing Practice (CGMP) for APIs. Because the methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API is adulterated," the USFDA stated in the warning letter. A warning letter issued by the USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product ca

Glenmark, FDC recall products from US market on manufacturing issues: USFDA

Drug firms Glenmark Pharmaceuticals and FDC Ltd are recalling products in the US market due to manufacturing issues, according to the US Food and Drug Administration (USFDA). In its latest Enforcement Report, the US health regulator said a US-based subsidiary of Mumbai-headquartered Glenmark Pharmaceuticals is recalling a certain number of a generic hypertension medication in the US market. New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling Carvediol tablets in strengths of 25 mg and 12.5 mg in the US, the US health regulator stated. The company is recalling the product as "N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit". The company initiated the Class II recall on January 22 this year. USFDA said FDC Ltd is recalling 1,18,104 bottles of a medication for the treatment of glaucoma. The drug firm is recalling the affected lot of Timolol Maleate ophthalmic solution USP produced at its Aurangabad-based plant, it added

Biocon Biologics investors are more confident after revenue growth: Mittal

There is market share gain compared to last year. Any biosimilar might be able to take on a four-five or six player market, said Siddharth Mittal, CEO and MD, Biocon

Lupin receives USFDA approval to market its generic HIV medications

Drug firm Lupin on Friday said it has received approval from the US health regulator to market a generic HIV medication in the US market. The company has received tentative approval from the US Food and Drug Administration (USFDA) under the US President's Emergency Plan for AIDS Relief (PEPFAR) for Abacavir, Dolutegravir and Lamivudine tablets, the Mumbai-base drug maker said in a statement. The company's product is a generic equivalent of ViiV Healthcare Company's Triumeq PD tablets for oral suspension, it added. This product would be manufactured at the drug firm's Nagpur facility and will be supplied to low-and middle-income countries, it said. The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen, indicated for the treatment of HIV-1 infection in pediatric patients aged at least 3 months and weighing at least 6 kg. "The tentative approval from the USFDA for our Abacavir, Dolutegravir and

Zydus Life up 2% on USFDA nod for Phase II(b) clinical trial for Usnoflast

Zydus Life share rose after it received approval from USFDA to conduct Phase II(b) clinical trial for Usnoflast, a novel oral NLRP3 inflammasome inhibitor in patients with ALS

USFDA issues Establishment Inspection Report to Gland Pharma; stock up 3%

The pharmaceutical company's shares were quoted at an all-time high of Rs 4,350 on August 21, 2021, while they touched their all-time low of Rs 861.50 on May 22, 2023

Indian pharma improves compliance with USFDA; fewer OAI cases in 2024

Recent USFDA data reveals a decline in the number of adverse classification outcomes of inspections

USFDA restricts imports of certain Viatris drugs made at India facility

The FDA has issued a warning letter to Viatris related to its drug manufacturing facility in Indore in the central Indian state of Madhya Pradesh

Granules India gets US regulator FDA's approval for generic ADHD drug

Drug firm Granules India on Tuesday said its subsidiary has received approval from the US health regulator for a generic medication used to treat attention-deficit hyperactivity disorder. Granules Pharmaceuticals, Inc (GPI) has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate chewable tablets, the drug firm said in a statement. The approved drug is available in multiple strengths; 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg, it added. The company's product is the generic equivalent to Takeda Pharmaceuticals' Vyvanse chewable tablets, the company said. The medication is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged six years and older, as well as moderate to severe binge eating disorder (BED) in adults. Lisdexamfetamine dimesylate chewable tablets are currently published on the FDA Drug Shortages List, emphasising ..

Aurobindo Pharma, Glenmark, and Zydus recall products in US over mfg issues

Drug makers Aurobindo Pharma, Glenmark and Zydus are recalling products in the US market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report of US Food and Drug Administration (USFDA), Aurobindo Pharma USA Inc, a subsidiary of Hyderabad-based drug maker, is recalling over 1 lakh bottles of Cinacalcet tablets in multiple strengths. The New Jersey-based firm is recalling the product due to "GMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit," the US health regulator said. The company initiated the Class II recall on November 7 this year. Cinacalcet tablets are used to treat hyperparathyroidism. Similarly, a US-based subsidiary of Glenmark Pharmaceuticals is recalling around 90,000 bottles of Diltiazem Hydrochloride extended-release capsules (multiple strengths) in the US market. New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling the affected lot of Diltiazem Hydrochloride ...

Bajaj Healthcare rises 6% as Gujarat API site gets nod from TGA, Australia

The mentioned site has already received approval from the US FDA (US Food and Drug Administration) and EU, as per the filing

Biocon share falls 4% after USFDA issues VAI tag for Bengaluru's API unit

Biocon's Bengaluru API facility was inspected between September 23 to September 27, 2024

USFDA approves Biocon Biologics' biosimilar for Crohn's disease, psoriasis

YESINTEK, a monoclonal antibody, is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis

Lupin recalls over 600,000 bottles of hypertension drug in US: USFDA

Drug firm Lupin is recalling over six lakh bottles of a medication indicated for high blood pressure in the US due to deviation from current good manufacturing practices (CGMP), according to the US health regulator. As per its latest Enforcement Report, US Food and Drug Administration (USFDA), stated that Dr Reddy's Laboratoties is also recalling a product in the US due to a manufacturing issue. Baltimore-based Lupin Pharmaceuticals Inc, a subsidiary of Mumbai-based Lupin, is recalling 6,16,506 bottles of Ramipril capsules in strengths of 2.5 mg, 5 mg and 10 mg, the US health regulator said. The affected lot is manufactured at Lupin's Goa-based manufacturing facility, it stated. The company is recalling 1,12,770 bottles of 2.5 mg tablets; 1,46,322 bottles of 5 mg tablets and 3,57,414 bottles of 10 mg tablets, it said. The US health regulator noted that the company is undertaking Class II voluntary recall due to "CGMP Deviations: Active pharmaceutical ingredient was sourced from an

USFDA issues seven observations to Dr Reddy's Hyderabad manufacturing plant

Dr Reddy's Laboratories Ltd on Tuesday said the US health regulator has issued a Form 483 with seven observations to its active pharmaceutical ingredient manufacturing facility in Bollaram, Hyderabad. "The US Food & Drug Administration (USFDA) today completed a GMP inspection at our API manufacturing facility (CTO-2) in Bollaram, Hyderabad," Dr Reddy's Laboratories Ltd (DRL) said in a regulatory filing. The inspection was conducted from November 13-19, 2024, it added. "We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline," the company said. 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.

Drug maker Cipla gets 8 observations from USFDA for Bengaluru facility

Drug maker Cipla on Wednesday said the US health regulator has issued eight observations after inspecting its Bengaluru-based plant. The US Food and Drugs Administration (USFDA) conducted an inspection at the company's manufacturing facility in Virgonagar, Bengaluru from November 7- 13, the Mumbai-based based drug maker said in a filing to BSE. On conclusion of the inspection, the company received eight observations in Form 483, it added. The company said it will work closely with the USFDA and remain committed to addressing these observations comprehensively within stipulated time.

Alembic Pharmaceuticals gets USFDA nod for hypertension treatment capsules

Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic Diltiazem Hydrochloride extended-release capsules indicated for the treatment of hypertension. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules of strengths 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, Alembic Pharmaceuticals Ltd (Alembic) said in a statement. These capsules are indicated for the treatment of hypertension. These capsules may be used alone or in combination with other antihypertensive medications. Moreover, Diltiazem Hydrochloride is also indicated for the management of chronic stable angina and angina due to coronary artery spasm, the company said. Diltiazem Hydrochloride extended-release capsules 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg have an estimated market size of USD 105.3 million for the 12 months ended June 2024, the company ...

McDonald's E coli case count rises as officials inspect onion grower

Federal officials have reported more cases of E. coli poisoning among people who ate at McDonald's, as government investigators seeking the outbreak's source identified an onion grower of interest in Washington state. The Food and Drug Administration said 90 people across 13 states have fallen ill in the outbreak, up from 75 at the end of last week. The number of people hospitalised increased by five, to 27 people. One death has been tied to the outbreak. Officials have said raw, slivered onions on McDonald's Quarter Pounder hamburgers are the likely source of the E. coli. McDonald's said the onions came from a single supplier, the California-based Taylor Farms. The company has since recalled the yellow onions it sent to McDonald's and other restaurant chains. The FDA said Wednesday it has begun inspecting Taylor Farm's processing centre in Colorado Springs as well as an onion grower of interest in Washington state. It did not name the grower. More than 80 per cent of people with E