Page 2 - Usfda

Alembic Pharma shares jump 5% after USFDA approval; check details here

Alembic Pharma share price surged up to 5 per cent at Rs 1,170.60 per share on the BSE in Thursday's intraday trade

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

Dr Reddy's Laboratories and Lupin are recalling products in the US due to manufacturing issues, as per the US Food and Drug Administration (USFDA). Dr Reddy's Laboratories Inc, a subsidiary of Hyderabad-based drug firm, is recalling Ibuprofen tablets in multiple strengths, the US health regulator said in its latest enforcement report. Ibuprofen tablets are indicated for pain relief and fever. New Jersey-based Dr Reddy's Laboratories Inc. is recalling 1,03,298 bottles (800 mg); 31,802 bottles (600 mg); and 14,940 bottles (400 mg) of Ibuprofen tablets in the US market, USFDA said. The company is recalling the affected lot due to "Failed impurities/degradation specifications," it added. "Results for unknown impurity were 0.13 per cent and 0.11 per cent, respectively, exceeding the 0.10 per cent specification limit," USFDA noted. The company initiated the Class II nationwide recall on August 6 this year. USFDA stated that Lupin is recalling 4,554 bottles of Cefixime for Oral Suspen

Zydus Lifesciences gets USFDA nod to mkt Scopolamine transdermal system

Zydus Lifesciences Ltd on Friday said it has received the final approval from the US Health regulator to market its Scopolamine transdermal system indicated to prevent nausea and vomiting under different circumstances. The approval granted by the US Food and Drug Administration (USFDA) is to market the Scopolamine transdermal system of dosage 1 mg/3 days, Zydus Lifesciences said in a regulatory filing. The Scopolamine transdermal system will be produced at the group's transdermal manufacturing site at SEZ, Matoda, Ahmedabad, it added. Scopolamine transdermal System is indicated to prevent nausea and vomiting after anaesthesia, narcotic pain medicines, and surgery. It is also used to prevent nausea and vomiting caused by motion sickness. "This is the fifth abbreviated new drug application (ANDA) approval for Zydus in the transdermal portfolio, leveraging the group's strengths in the manufacturing of complex drug device dosage forms," the company said. Scopolamine Transdermal System

Aurobindo, others recall products in US market over production issue: USFDA

Drug makers Aurobindo Pharma, Glenmark and FDC are recalling products in the US due to manufacturing issues, as per the US Food and Drug Administration (USFDA). Aurobindo Pharma USA Inc -- a unit of Hyderabad-based drug major -- is recalling 240 bottles of pain-relieving medication Healthy Living Acetaminophen, Aspirin (NSAID) and caffeine tablets. As per the latest enforcement report of USFDA, the company is recalling the affected lot due to "Missing Label". Some bottles are missing the manufacturer's label that includes the drug facts information, the US health regulator said. The New Jersey-based Aurobindo Pharma USA Inc initiated the Class 1 recall on July 11, it said. As per the US health regulator, a Class I recall pertains to defective products that can cause serious health problems. Similarly, a US-based subsidiary of Glenmark Pharmaceuticals is recalling 2,404 bottles of Indomethacin Extended-Release Capsules, produced at a Madhya Pradesh plant, due to "Failed Dissolutio

USFDA pulls up Eugia for manufacturing lapses at its Telangana plant

The US health regulator has pulled up Aurobindo Pharma's subsidiary Eugia for manufacturing lapses at its Telangana-based plant. In a warning letter to Eugia Pharma Specialities CEO Yugandhar Puvvala, the US Food and Drug Administration (USFDA) pointed out that the company failed to ensure the accuracy of data for production and process simulation. "Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards," USFDA stated. The US health regulator said it inspected the Patancheru (Mandal), Sangareddy, Hyderabad-based plant from January 22 to February 2, 2024. "You failed to ensure the accuracy of data in records for both production and process simulations (media fills)," USFDA noted. Besides, the operators also falsified environmental monitoring records for the multiple aseptic filling lines, including for viable active air samples and non-viable particle counts which

Indoco Remedies stock soars over 5% on USFDA approval for opioids drug

Indoco Remedies stock surged up to 5.53 per cent at Rs 358.60 per share on the BSE in Wednesday's intraday deals

US FDA declines to approve Regeneron's therapy for common blood cancer

FDA, in a so-called 'complete response letter', said that the sole issue identified for approval is related to findings from a pre-approval inspection at a third-party manufacturer

Alembic Pharma gets approval from US FDA to market generic medication

Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic product indicated for prophylaxis of deep vein thrombosis. The company has received approval from the US Food and Drug Administration (USFDA) to market Dabigatran Etexilate Capsules (110 mg), the drug firm said in a regulatory filing. Dabigatran Etexilate Capsules are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. The approved product is therapeutically equivalent to Boehringer Ingelheim Pharmaceuticals Inc's Pradaxa Capsules (110 mg). The company said it now has a cumulative total of 211 ANDA (abbreviated new drug application) approvals from the USFDA. Shares of the company on Tuesday closed 3.17 per cent down at Rs 1,076 apiece on the BSE.

Dr Reddy's Labs shares drop after US FDA gives VIA tag to Vizag facilities

Shares of Dr Reddy's Laboratories slipped up to 2 per cent at Rs 6,875.05 per share on the BSE in Monday's intraday trade

USFDA scrutiny delays generic drug approvals for major Indian pharma firms

Big Pharma companies Cipla, Sun Pharma, Aurobindo Pharma, Dr Reddy's, and Lupin face intense scrutiny from the US Food and Drug Administration (USFDA)

Sun Pharma receives US FDA approval for drug to treat alopecia areata

Autoimmune disorder characterised by hair loss affects some 700,000 people in the US

Sun Pharma hits all time high on US FDA nod for alopecia drug 'Leqselvi'

This came after Sun Pharmaceuticals announced that the US Food and Drug Administration (USFDA) has approved its new drug application for Deuruxolitinib, a new treatment for Alopecia Areata

Gland Pharma, Zydus Lifesciences secure USFDA approvals for key medications

Gland Pharma, a Hyderabad-based generic injectable-focused company, received tentative approval for Latanoprostene Bunod Ophthalmic Solution, 0.024 per cent

USFDA classifies inspection of Zydus unit as 'official action indicated'

Zydus Lifesciences on Thursday said the US health regulator has cautioned that its Gujarat-based injectables plant may be subject to regulatory actions. The company said it has received a report from the US Food and Drug Administration (USFDA) for the inspection conducted at its injectables manufacturing facility located at Jarod, near Vadodara, Gujarat between April 15-23, 2024. The USFDA has determined that the inspection classification of this facility is Official Action Indicated (OAI), it added. According to FDA, OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during the inspection. "The company will work closely with the agency to resolve the regulatory status of this facility expeditiously," the drug maker said. Shares of Zydus Lifesciences settled marginally up at Rs 1,185.30 apiece on the BSE.

Glenmark Pharma receives USFDA approval for seizure treatment drug

The approval by the US Food & Drug Administration (USFDA) is for Topiramate capsules of strengths 15 mg and 25 mg, Glenmark Pharmaceuticals said in a statement

Zydus Lifesciences hits all time high on USFDA nod for multiple drugs

Shares of Zydus Lifesciences zoomed up to 1.93 per cent, hitting its all time high at Rs 1203.20 per share on the BSE in Thursday's intraday trade

Zydus Life gets USFDA approval to market heart failure treatment drug

Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to market its generic Sacubitril and Valsartan tablets combination used to treat chronic heart failure in adults. The approval by the US Food and Drug Administration (USFDA) is to market Sacubitril and Valsartan tablets of strengths 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, Zydus Lifesciences said in a regulatory filing. Sacubitril and Valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalisation. The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, the company added.

Alembic Pharma receives USFDA nod for Bromfenac Ophthalmic Solution

The drug is expected to be manufactured in Alembic's manufacturing facilities in Gujarat, according to sources close to the company

Dr Reddy's, Sun Pharma recall drugs in US due to production issues: USFDA

Dr Reddy's Laboratories and Sun Pharma are recalling products in the US due to manufacturing issues, as per the latest Enforcement Report by the US Food and Drug Administration (USFDA). According to the report, Dr Reddy's Laboratories is recalling drugs to treat insomnia and gout in the American market. New Jersey-based Dr Reddy's Laboratories, Inc., a unit of Hyderabad-based drug major, is recalling 13,752 bottles of Eszopiclone tablets, the USFDA stated. The affected lot has been produced at Dr Reddy's Bachupally plant in Telangana. As per the USFDA, the drug firm is recalling the affected lot due to "Failed Impurities/Degradation Specifications". The company issued the Class III nationwide recall on June 4 this year. As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences". Dr Reddy's Laboratories, Inc. is also recalling 20,520 units of Allopurinol tablets in the

USFDA pulls up Sun Pharma for manufacturing issues at Dadra facility

Sun Pharma failed to adequately clean and maintain equipment used for drug manufacturing at its Dadra-based manufacturing plant, as per the US Food and Drug Administration (USFDA). In a warning letter issued to company's Managing Director Dilip Shanghvi on June 18, the US health regulator stated it inspected the plant in the Union Territory of Dadra and Nagar Haveli and Daman and Diu from December 4-15, 2023. "Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitise 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 USFDA said. The warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals at the facility, it stated. USFDA further noted that the company's investigations