Page 4 - Usfda

Cipla gets USFDA nod to market generic version of cancer drug Abraxane

Drug major Cipla on Friday said it has received approval from the US health regulator to market a generic cancer treatment drug. The company has received the final approval from the US Food and Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) submitted for paclitaxel protein-bound particles for injectable suspension (albumin-bound), 100 mg/vial, single-dose vial, Cipla said in a regulatory filing. Cipla's protein-bound paclitaxel is a generic therapeutic equivalent version of Bristol Myers Squibb's Abraxane for injectable suspension 100 mg/vial. Protein-bound paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas. The product is expected to be launched in the first half of the current fiscal year in the US, the Mumbai-based drugmaker said. Shares of the company were trading 2.73 per cent up at Rs 1,454.90 apiece on the BSE.

Strides Pharma initiates Class-II recall of Testosterone Gel in US

The recall was voluntarily initiated by Strides Pharma on March 5, 2025, and remains ongoing. Consignees have been informed about this recall formerly, although public press release has not been issue

US FDA workers brace for mass layoffs amid health services job cuts

As they readied to leave work Monday, some workers at the Food and Drug Administration were told to pack their laptops and prepare for the possibility that they wouldn't be back, according to an email obtained by The Associated Press. Nervous employees roughly 82,000 across the nation's public health agencies waited to see whether pink slips would arrive in their inboxes. The mass dismissals have been expected since Secretary Robert F. Kennedy Jr. announced last week a massive reorganization that will result in 20,000 fewer jobs at the Department of Health and Human Services. About 10,000 will be eliminated through layoffs. The email sent to some at the FDA said staffers should check their email for a possible notice that their jobs would be eliminated, which would also halt their access to government buildings. An FDA employee shared the email with AP on condition of anonymity, because they weren't authorized to disclose internal agency matters. Kennedy has criticized the ...

Sun Pharma, Zydus recall medicines in US over quality concerns: USFDA

Sun Pharma and Zydus Pharmaceuticals are recalling products in the US market due to manufacturing issues, according to the US Food and Drug Administration (USFDA). The New Jersey-based Sun Pharmaceutical Industries, Inc is recalling 9,840 bottles of Morphine Sulfate extended-release tablets for "Failed Dissolution Specifications", the US health regulator stated in its latest Enforcement Report. The company initiated the Class II nationwide (US) recall on February 6, 2025. USFDA stated that Zydus Pharmaceuticals (USA) Inc is recalling a lot of Nelarabine Injection, used in the treatment of certain cancers, in the US. The company is recalling 36,978 vials of Nelarabine Injection in strength of 250mg/50mL, (5mg/mL) for "Failed Impurities/ Degradation Specifications," USFDA stated. The company initiated the Class II recall in February. Zydus is also recalling 1,893 vials of the drug in strength of 250mg/50mL, (5mg/mL). The company initiated the Class II nationwide recall on February

Here's why Indoco Remedies shares were under pressure on March 11; details

The fall in the share price came after the company announced that its Clinical Research Organisation, AnaCipher, located at Hyderabad, has received one Form 483 at the end of the inspection by USFDA

USFDA flags Granules India for storage, equipment lapses at Telangana plant

The US health regulator has pulled up Granules India for failing to maintain buildings for drug storage and avoiding adequate procedures regarding cleaning and maintenance of equipment at its Telangana-based formulations plant. In a warning letter to the company's Chairman and Managing Director Krishna Prasad Chigurupati, the US Food and Drug Administration (USFDA) stated that the company failed to establish and follow adequate written procedures for maintaining equipment at the Medchal-Malkajgiri-based manufacturing facility. The USFDA inspected the facility from August 26 to September 6, 2024. "Our investigators observed significant contamination in multiple ducts of non-dedicated use in the preparation of finished drug products manufactured at your facility," the USFDA stated. While filters were installed to prevent contamination, inadequate cleaning and maintenance processes rendered them ineffective, it added. "Swab samples collected from the ducts by your firm during the ...

Glenmark recalls 1.5 million bottles of ADHD medication in US: USFDA

Glenmark Pharmaceuticals is recalling close to 15 lakh bottles of a generic medication used in the treatment of attention deficit hyperactivity disorder in the US market, according to the US health regulator. Glenmark Pharmaceuticals Inc, USA, a subsidiary of the Mumbai-based drug maker, is recalling around 14.76 lakh bottles of Atomoxetine Capsules in multiple strengths. The company is recalling the affected lot due to "CGMP Deviations", the US Food and Drug Administration (USFDA) said in its latest Enforcement Report. The recall is due to "presence of N-Nitroso Atomoxetine impurity above the FDA recommended limit," it added. New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling the made-in-India product in strengths ranging from 10 mg to 100 mg, USFDA stated. The company initiated the Class II recall on January 29 this year. As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medic

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