Page 8 - Usfda

Zydus Life stock sheds 5% as USFDA issues 10 observations for Vadodara unit

Zydus Lifesciences share price update: The USFDA conducted an inspection at the Injectable Manufacturing site situated at Jarod, near Vadodara, between April 15 and April 23, 2024

USFDA pulls up Natco Pharma for several violations at Telangana plant

Natco Pharma failed to maintain cleanliness, sterilise equipment and utensils at appropriate intervals at its Telangana-based plant, as per the US health regulator. In the warning letter to the company, US Food and Drug Administration said its investigators observed various violations at the finished pharmaceuticals plant located at Kothur Village in Telangana. The USFDA inspected the facility from October 9 to 18, 2023. "Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements," the US health regulator noted. It further said: "Your cleaning procedure for your non-dedicated equipment is inadequate." Cross-contamination is not uniform, and the testing of control samples and placebo batches failed to ...

Glenmark Pharma recalls 6,528 bottles of blood pressure drug in US

Glenmark Pharmaceuticals is recalling 6,528 bottles of a medication used to treat high blood pressure in the American market due to failed dissolution specifications, the US health regulator said. The US-based arm of the Mumbai-headquartered drug firm is recalling the affected lot of Diltiazem Hydrochloride extended-release capsules, the US Food and Drug Administration said in its latest Enforcement Report. The affected lot has been produced in India and is being recalled by New Jersey-based Glenmark Pharmaceuticals Inc for "failed dissolution specifications", the USFDA said. "Out of Specification (OOS) was reported in a test of dissolution at the 12th month time point in long-term stability study," it noted. Glenmark initiated Class II recall of the drug across the US on March 26 this year. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences

USFDA issues 'warning letter' to Kilitch Healthcare over GMP violation

The FDA questioned Kilitch's quality system, citing concerns about its ability to ensure data accuracy and integrity for drug safety

Natco Pharma receives warning letter from USFDA for Telangana plant

Natco Pharma on Tuesday said it has received a warning letter from the US health regulator for its Telangana-based manufacturing plant. The US Food and Drug Administration (USFDA) had issued eight observations under Form 483 after inspecting the company's Kothur-based formulation facility. The inspection was conducted by USFDA from October 9 to October 18, 2023. "We wish to inform you that the company has received a warning letter dated April 8, 2024 from the USFDA," the drug firm said in a regulatory filing. The company does not believe that the warning letter will have an impact on supplies or the existing revenues from this facility, it added. "It may cause delay/withholding of pending product approvals from this site," Natco Pharma said. The drug firm will respond to the letter within the stipulated timelines and work closely with the USFDA to address the concerns in a holistic and timely manner to ensure sustained compliance, it said. A warning letter is issued when the US

Wardwizard Foods & Beverages to enters US mkt as it gets USFDA registration

Wardwizard Foods and Beverages, maker of frozen and ready-to-eat foods, on Monday announced its foray into the US market following the USFDA registration. The Vadodara, Gujarat-based company will commence exporting to US market in the first quarter of this fiscal, according to a statement from the company. "The initial phase will focus on key cities including Chicago, New Jersey and Texas, where consumers will have the chance to indulge in the rich and authentic tastes of India's culinary offerings," it said. The firm offers convenient RTE (ready-to-eat) meals to frozen products, spices, savory sauces, condiments, and beverages. Chairperson and Managing Director Sheetal Bhalerao said: "The attainment of USFDA registration stands as a validation to our product quality and regulatory compliance.

Zydus Lifesciences gets 4 observations from USFDA for Gujarat plant

Zydus Lifesciences on Wednesday said the US health regulator has issued a Form-483 with four observations following the inspection of its Ahmedabad-based SEZ Onco Injectable manufacturing plant. The US Food and Drug Administration (USFDA) conducted the cGMP (Current Good Manufacturing Practice) inspection at the facility from March 18-27, 2024, the company said in a regulatory filing. The inspection closed with four observations, it added. There were no data integrity-related observations, the drug firm said. Zydus will closely work with the USFDA to address the observations, it added. Shares of the company ended 1.82 per cent lower at Rs 999.60 apiece on BSE.

Lupin gets USFDA nod to market a generic drug to treat bacterial infections

Drug maker Lupin on Friday said it has received approval from the US health regulator to market a generic medication to treat bacterial infections, in America. The company has received approval from the USFDA for Doxycycline for Injection USP, the Mumbai-based drug maker said in a statement. The company's product is the generic equivalent of Pfizer Inc's Vibramycin for injection, it added. The product will be manufactured at its Nagpur facility, Lupin said. Doxycycline for Injection USP is indicated to reduce the development of drug-resistant bacteria. As per the IQVIA MAT January 2024 data, Doxycycline for Injection USP had estimated annual sales of USD 47 million in the US market.

Sun Pharma recalls around 55,000 bottles of generic medication in US

Sun Pharma is recalling about 55,000 bottles of a generic medication to treat bowel disease in the American market, according to the US Food & Drug Administration (USFDA). As per the latest Enforcement Report by the US health regulator, New Jersey-based Sun Pharmaceutical Industries Inc, a unit of the Mumbai-headquartered drug major, is recalling 54,960 bottles of Mesalamine extended-release capsules in the American market. Mesalamine delayed-release capsules are indicated for the treatment of mild to moderate ulcerative colitis. The affected lot of capsules have been manufactured by Sun Pharmaceutical Industries at its Mohali-based manufacturing plant and distributed in the US market by Sun Pharmaceutical Industries Inc. As per the USFDA, the company has initiated the Class II recall due to "Failed Dissolution Specifications". The company initiated the Class II recall on February 5 this year. As per the USFDA, a class II recall is initiated in a situation in which the use of, or

Strides Pharma receives USFDA approval for neurology medication Gabapentin

Gabapentin is widely used in managing neuropathic pain associated with diabetic neuropathy, postherpetic neuralgia, and central pain

US FDA approves Eyenovia's eye drops to reduce pain: Formosa Pharma

Eyenovia acquired US commercial rights of the drug last August from Formosa

Biocon Biologics signs agreement with Janssen Biotech for psoriasis drug

Biocon said that the U.S. FDA has accepted the Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway

Zydus Lifesciences gets USFDA nod for generic drug to prevent chest pain

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator to manufacture and market its generic Isosorbide Mononitrate extended-release tablets used to prevent chest pain in patients with a certain heart condition. The approval by the US Food and Drug Administration (USFDA) is to manufacture and market Isosorbide Mononitrate Extended-Release, of strengths 30 mg, 60 mg, and 120 mg, Zydus Lifesciences said in a regulatory filing. Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition, coronary artery disease, it added. The product will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, the company said. Isosorbide Mononitrate extended-release tablets 30 mg, 60 mg, and 120 mg had annual sales of USD 47 million in the US, Zydus said citing IQVIA December 2023 data. PTI RKL.

Lupin gets approval from USFDA for pregnancy prevention drug 'Minzoya'

Pharma major Lupin Ltd on Friday said it has received approval from the US health regulator to market its generic 'Minzoya' tablets used to prevent pregnancy. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Minzoya (Levonorgestrel and Ethinyl Estradiol tablets, and Ferrous Bisglycinate tablets) of strengths 0.1 mg/0.02 mg and 36.5 mg, Lupin said in a regulatory filing. The drug is a generic equivalent of Balcoltra (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets) 0.1 mg/0.02 mg and 36.5 mg, of Avion Pharmaceuticals LLC, it added. The product will be manufactured at Lupin's Pithampur facility in India, the company said. Minzoya tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and Ethinyl Estradiol tablets, and Ferrous Bisglycinate tablets had estimated annual sales of USD 42 million in the US, the company said citing IQVIA MAT

Dr Reddy's Laboratories R&D facility gets VAI status in USFDA inspection

Last year in December, during the Good Manufacturing Practice (GMP) and Pre-Approval Inspection at the same facility concluded with three observations

Biocon gets USFDA approval to market generic anti-cancer medication

Biocon Ltd on Tuesday said it has received approval from the US health regulator for a generic anti-cancer medication. The company has received approval from the US Food and Drug Administration (USFDA) for Dasatinib tablets to market in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, Biocon said in a regulatory filing. The approval will further strengthen the company's portfolio of vertically integrated, complex drug products, it added. Shares of Biocon settled 4.97 per cent higher at Rs 298.75 apiece on the BSE.

Lupin secures a tentative USFDA approval for Rivaroxaban tablets

Lupin boasts 15 manufacturing sites, 7 research centres, and a global team of more than 20,000 professionals

USFDA finds new manufacturing lapses at pharma co Eli Lilly's plant: Report

Lilly said in a statement to Reuters that the inspection followed a company request to the FDA to make a change to its manufacture of migraine treatment Emgality

Lupin gets USFDA nod to market generic hyperuricemia treatment drug

Pharma major Lupin Ltd on Thursday said it has received approval from the US health regulator to market its generic Febuxostat tablets, indicated for the chronic management of hyperuricemia in adult patients with gout. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Febuxostat tablets of strengths 40 mg and 80 mg, a generic equivalent of Uloric tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals USA, Inc, Lupin said in a regulatory filing. The product will be manufactured at the company's Pithampur facility in India, it added. The company said Febuxostat tablets of strengths 40 mg and 80 mg are indicated for the chronic management of hyperuricemia (elevated serum uric acid level) in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol; who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Febuxostat tablets had estimated annual sales of U

Lupin receives USFDA approval to market generic hypertension drug

Drug maker Lupin on Sunday said it has received approval from the US health regulator to market a generic hypertension drug in America. The company has received approval from the US Food and Drug Administration (USFDA) for Propranolol Hydrochloride extended-release capsules in multiple strengths, Lupin Ltd said in a regulatory filing. The company's product is the generic version of ANI Pharmaceuticals' Inderal LA extended-release capsules, it added. The product will be manufactured at the company's Pithampur-based manufacturing plant, the drug firm stated. Propranolol Hydrochloride extended-release capsules USP are indicated in the management of hypertension. They may be used alone or in combination with other antihypertensive agents, particularly a thiazide diuretic. As per IQVIA MAT November 2023 data, Propranolol Hydrochloride extended-release capsules had estimated annual sales of USD 71 million in the US.