Page 4 - Usfda

Sun Pharma's Halol plant gets 8 USFDA observations post inspection

Drug major Sun Pharma on Saturday said the US health regulator has issued a Form 483 with 8 observations after inspecting its Halol (Gujarat) manufacturing plant. The US Food and Drug Administration (USFDA) conducted a good manufacturing practices (GMP) inspection at the Halol facility from June 2-13 2025, the Mumbai-based drug maker said in a regulatory filing. At the conclusion of the inspection, the USFDA issued a Form-483 with 8 observations, it added. As per the 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.

Lupin signs licensing deal with SteinCares for ranibizumab in LatAm

Lupin will manufacture biosimilar ranibizumab while SteinCares handles registration and marketing in Latin America, excluding Mexico and Argentina

Alembic Pharma receives USFDA approval for generic hypertension drug

Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for its generic version of amlodipine and atorvastatin tablets, used to treat high blood pressure. The final approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Amlodipine and Atorvastatin tablets of strengths 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, the company said in a statement. These are therapeutically equivalent to the reference-listed drug product, Caduet tablets of corresponding strengths of Pharmacia and Upjohn Co LLC, it added. Alembic said it has a cumulative total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from the USFDA.

What drove Indoco Remedies share price 6% higher today? Top details inside

Indoco Remedies' share price rose after the company received final USFDA approval for its ANDA to market Allopurinol tablets USP, 200 mg - a generic version of Zyloprim 200 mg by Casper Pharma LLC.

US FDA approves Novavax Covid vaccine with added conditions for use

According to the approval letter, the license restricts the use of the vaccine called Nuvaxovid to individuals aged 65 and older, and those between 12 and 64

Zydus gets USFDA approval for generic drug to treat multiple sclerosis

Zydus Lifesciences on Friday said it has received approval from the US health regulator to market a generic medication to treat multiple sclerosis. The company has received approval from the US Food and Drug Administration (USFDA) for Glatiramer Acetate Injection, 20 mg/mL and 40 mg/mL, single-dose prefilled syringes. The company's product is the generic version of Copaxone which is indicated for the treatment of relapsing forms of Multiple Sclerosis (MS). Zydus said the product, developed in collaboration with Chemi S.p.A., will be manufactured entirely in Europe. "This approval underscores Zydus' leadership in bringing complex, differentiated generics to market, reinforcing our commitment to providing a comprehensive range of therapeutic choices for patients," Zydus Lifesciences MD Sharvil Patel said. As per IQVIA MAT data, Glatiramer Acetate Injection had annual sales of USD 719 million in the US market. Shares of Zydus Lifesciences were trading 0.48 per cent up at Rs 876 apie

Gland Pharma gets USFDA nod for Vyzulta generic with 180-day exclusivity

Gland Pharma on Wednesday said it has received approval from the US health regulator for a generic medication to treat conditions related to high pressure in the eye. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Latanoprostene Bunod Ophthalmic Solution, (0.024 per cent), the drug firm said in a statement. The company's product is bioequivalent and therapeutically equivalent to Bausch and Lomb, Inc's Vyzulta ophthalmic solution, it added. The product is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The company is the exclusive first-to-file and is eligible for 180 days of generic drug exclusivity, Gland Pharma said. According to IQVIA, the product had sales of around USD 171 million in the US for the 12 months ending February 2025. Shares of Gland Pharma on Wednesday ended 1.04 per cent down at Rs 1,398.35 apiece on the BSE.

FDA review of Novavax Covid-19 vaccine sparks uncertainty about other shots

The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine -- the nation's only traditional protein-based option for the coronavirus -- is sowing uncertainty about updates to other vaccines, too. Novavax said on Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine after the agency grants full approval. The company said it had responded and that it believed its shot remains "approvable". But a weekend post on social media by FDA Commissioner Marty Makary suggested the prospect of needing a new trial before the shots' yearly strain update -- something unlikely to be possible before fall. That's raised questions about whether other vaccines will be caught in the turmoil. "I don't think because there's a strain change that this is a new product," said Dr Jesse Goodman of Georgetown University, a former FDA vaccine chief. If that's the new policy, "you'd always be doing clinical trials and you'd nev

SS Innovations lists on Nasdaq; shares trade under 'SSII' ticker

The trading commences on April 25, with the company's shares listed under the ticker symbol 'SSII'

Lupin gets USFDA nod for generic kidney disease treatment drug Tolvaptan

Pharma major Lupin Ltd on Thursday said it has received approval from the US health regulator for its generic version of Tolvaptan tablets indicated for a certain type of kidney disease. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Tolvaptan tablets of strengths 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, Lupin said in a regulatory filing. These are bioequivalent to Jynarque tablets in the same strengths of Otsuka Pharmaceutical Company Ltd, it added. "Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. This product will be manufactured at Lupin's Nagpur facility and will be launched soon," the company said. Commenting on the approval, Lupin CEO Vinita Gupta said,"This marks a significant entry into the nephrology segment and demonstrates our commitment to addressing the unmet needs of patients globally." Tolvaptan is indicated to slow kidney function decline in .

Aurobindo Pharma in focus: Why has the stock gained 3% in trade today?

Aurobindo Pharma Ltd share price: The up move in the stock came after the company arm Eugia Pharma Specialities, received final approval from USFDA to manufacture and market Dasatinib tablets

Dr Reddy's, Lupin recall products in US due to manufacturing errors: USFDA

Dr Reddy's Laboratories and Lupin are recalling products in the US market due to labelling and manufacturing errors, respectively, according to the US health regulator. As per its latest Enforcement Report, US Food and Drug Administration (USFDA) said a US-based subsidiary of the Hyderabad-based drug major is recalling certain batches of a generic antiepileptic drug in the US market. Princeton-based Dr Reddy's Laboratories, Inc is recalling 4,010 bags of Levetiracetam 0.75 pc in Sodium Chloride Injection (1,000 mg/100 mL) in the US due to labelling mix up, USFDA said. "The infusion bag is incorrectly labelled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL," it added. The company has issued the Class 1 nationwide (US) recall on March 13 this year, the US health regulator noted. As per the USFDA, a Class I recall pertains to .

Glenmark, Sun Pharma, Zydus recall products in US over manufacturing issues

Drug makers Glenmark, Sun Pharma and Zydus are recalling products in the US for manufacturing issues, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report. As per the US health regulator, Mumbai-based Glenmark is recalling over 25 products in the US market due to Current Good Manufacturing Practice (CGMP) deviations. New Jersey-based Glenmark Pharmaceuticals Inc is recalling affected lots of medications like Propafenone Hydrochloride extended-release capsules and Solifenacin Succinate Tablets in America, the USFDA said. It is also recalling products like Voriconazole Tablets, Lacosamide Tablets, Frovatriptan Succinate Tablets and Rufinamide Tablets. The company initiated the Class II recall on March 13 this year. As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal. A .

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