USFDA
India pharma units fare better in US checks in 2023
The drug regulator United States Food and Drug Administration (USFDA) has classified 13%, or 19 out of 145 inspections it carried out against Indian facilities, as Official Action Indication (OAI) in 2023, which is lower than the global average of 15% OAIs, according to a report by Indian Pharmaceutical Alliance and McKinsey & Company said.
Norms soon on disposing of expired medicines
The document is in the final stages of completion. It will include procedures to be followed for disposal, collection, storage and transportation of expired and unused drugs. Improper disposal of medications that have crossed the expiry date mentioned on the label or not used by the individual for whom they were prescribed and purchased may be hazardous to public health, animal health and environment, officials said.
Lupin, Eugia recall products from US market: USFDA
Drugmakers Lupin and Aurobindo Pharma are recalling products from the American market due to manufacturing issues, as reported by the US Food and Drug Administration (USFDA). Lupin Pharmaceuticals Inc, a US-based unit of Lupin, is specifically recalling 3,552 bottles of Cefixime for Oral Suspension (USP 200 mg/5 mL) because of "failed content uniformity specifications."
Biocon gets 4 observations from USFDA for Andhra Pradesh facility
Biocon received four observations from the US health regulator after a GMP inspection at its API facility in Andhra Pradesh.
Alembic Pharma gets USFDA nod for Dabigatran Etexilate capsules
Alembic Pharmaceuticals Ltd received final approval from the US health regulator for generic Dabigatran Etexilate capsules 75 mg and 150 mg to reduce stroke and blood clots in adults with a specific medical condition.
Alembic Pharma gets USFDA nod for generic injection to treat hereditary angioedema
The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) for Icatibant injection of strengths 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe, Alembic Pharmaceuticals said in a regulatory filing.
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USFDA issues Form 483 with five observations to Torrent Pharma unit
Torrent Pharmaceuticals announced that the US Food and Drug Administration (USFDA) issued a Form 483 with five observations after inspecting its manufacturing plant in Indrad, Gujarat, from June 3 to June 12. The inspection included a pre-approval inspection (PAI) and a Good Manufacturing Practice (GMP) inspection. The company stated that there were no observations related to data integrity. Torrent Pharma plans to respond to the USFDA within the prescribed time frame and work closely with the agency to address the observations promptly.
Glenmark gets USFDA nod to market generic drug
Glenmark Pharmaceuticals announced that it has received USFDA approval to market its generic Esomeprazole Magnesium delayed-release capsules, used to treat excess stomach acid conditions. This generic version of Haleon US Holdings LLC's Nexium is expected to compete in a market where Nexium24 HR 20 mg capsules have annual sales of approximately $259.2 million
Indoco Remedies gets USFDA nod to market generic diabetes drug
Indoco Remedies on Thursday said it has received approval from the US health regulator to market a generic diabetes medication. The company has received tentative approval from the US Food and Drug Administration (USFDA) for abbreviated new drug application (ANDA) for Canagliflozin and Metformin Hydrochloride tablets in various strengths, Indoco Remedies said in a regulatory filing.
Zydus Lifesciences gets USFDA nod for asthma treatment drug
Zydus Lifesciences Ltd receives final USFDA approval to market generic Theophylline extended-release tablets of strengths 300 mg and 450 mg for asthma and COPD treatment. The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ, India, with annual sales of USD 12.6 million citing IQVIA MAT March 2024 data.
Strides Pharma unit gets USFDA nod for generic drug to treat gastrointestinal diseases
Strides Pharma Science on Wednesday said its unit has received approval from the US health regulator to market a generic medication used in the treatment of gastrointestinal diseases. Singapore-based Strides Pharma Global Pte. Ltd, has received approval for the generic version of Sucralfate Oral Suspension, 1gm/10 mL, from the US Food & Drug Administration (USFDA), the drug firm said in a statement.
USFDA approves Biocon Biologics' biosimilar product to treat ophthalmology conditions
Biocon Biologics received US Food and Drug Administration (USFDA) approval for biosimilar Yesafili, a vascular endothelial growth factor inhibitor for various ophthalmology conditions, including age-related macular degeneration. Yesafili is similar to Eylea. CEO Shreehas Tambe highlighted the company's milestone in bringing interchangeable insulin and biosimilars to patients. The approval comes as 19.8 million Americans live with macular degeneration, with aflibercept sales reaching $5.89 billion in 2023.
Dr Reddy's, Sun Pharma, Aurobindo recall products in US
The company is also recalling another lot of sapropterin dihydrochloride for the same reason, it added. The USFDA said the drug maker initiated the Class I recall in the US on April 8 this year. As per the US health regulator, a Class I recall pertains to defective products that can cause serious health problems.
Zydus Lifesciences gets USFDA approval for generic acne treatment gel
Zydus Lifesciences Ltd received final approval from the US Food and Drug Administration (USFDA) to market its generic version of Dapsone gel 7.5% for acne treatment. The gel is manufactured at their facility in Ahmedabad. Dapsone gel 7.5% had annual sales of $35.8 million in the US, according to IQVIA MAT March 2024 data, as reported in a regulatory filing.
USFDA issues Form 483 with 1 inspectional observation to Cipla's Kurkumbh unit
A routine current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at the company's manufacturing facility at Kurkumbh, Maharashtra from April 29, 2024, to May 8, 2024, Cipla said in a regulatory filing.
Maiva Pharma raises Rs 1,000 cr from Morgan Stanley PE and India Life Sciences Fund
Maiva Pharma has raised Rs 1,000 crore from Morgan Stanley Private Equity Asia and India Life Sciences Fund, including both primary and secondary funding. The funds will be used to set up a new manufacturing facility near Karnataka's Hosur, with capabilities in sterile dosage forms, including pre-filled syringes, bags, oncology, and hormonal injectables. Maiva's complex injectables development and manufacturing capability, strong compliance and regulatory standards, and transparency differentiate the company from competitors.
Glenmark Pharma gets USFDA nod for generic anti-inflammatory drug
Glenmark Pharmaceuticals received USFDA approval for generic Acetaminophen and Ibuprofen tablets. The product, a version of Advil Dual Action, will be distributed by Glenmark Therapeutics Inc, USA. Advil Dual Action achieved annual sales of around USD 84.1 million. Glenmark has 195 products authorized for distribution and 52 ANDAs pending approval.
Zydus Lifesciences launches generic drug for overactive bladder in US market
Zydus is among the first suppliers to launch the generic version of Mirabegron extended-release tablets (USP 25 mg) in the US market. The company is also preparing to launch the 50 mg tablets in the market. Mirabegron is indicated for the treatment of Overactive Bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.
USFDA pulls up Natco Pharma for manufacturing lapses at Telangana plant
Natco Pharma's Telangana plant violated cleanliness and sterilisation standards at Kothur Village facility per USFDA. The warning letter mentioned cross-contamination, inadequate cleaning procedures, and the need for comprehensive investigations and corrective actions.
Jubilant gets VAI classification from USFDA for Roorkee unit
As per the USFDA, a VAI inspection classification indicates that although investigators found and documented objectionable conditions during the inspection, FDA will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action at this time.
ChrysCap buys small stake in generics company La Renon for Rs 600 cr
Incorporated in 2007 by Pankaj Singh, La Renon is engaged in the manufacturing and marketing of branded generic formulations. ChrysCapital is close to acquiring a minority stake in La Renon Healthcare via secondary sale of shares, at a valuation of Rs 6,500 crore ($800 million), ET first reported on February 12.
India's pharma exports to US surge 15% in 11 months of FY24
The pace of exports has more than doubled from the 6.18% growth in the same period of FY23, according to estimates by Pharmaceutical Export Promotion Council (Pharmexcil).
USFDA issues warning letter to Kilitch Healthcare for Navi-Mumbai plant
The US Food and Drug Administration (USFDA) has issued a warning letter to Kilitch Healthcare India for manufacturing lapses at its plant in Maharashtra. The letter highlights various violations of current good manufacturing practice (CGMP) regulations, including packing drugs in insanitary conditions and failing to establish proper procedures to prevent contamination. The USFDA observed that the facility was poorly cleaned and maintained, posing risks of contamination. Kilitch Healthcare has committed to suspending production of all drugs for the US market. The company must address the violations and provide a plan for corrective action.
Dr Reddy's launches migraine management device in Europe
The launch marks the company's entry into digital therapeutics in Europe, the Hyderabad-based drug major said in a statement. Nerivio is approved by the US Food and Drug Administration (USFDA), and is CE-mark certified in Europe. Dr Reddy's launched Nerivio in India last year.
Natco Pharma gets warning letter from USFDA for Telangana plant
Natco Pharma, a pharmaceutical company, received a warning letter from the USFDA regarding its manufacturing plant in Telangana. This came after the FDA conducted an inspection of the company's facility in Kothur last October, issuing eight observations under Form 483.
Strides Pharma gets USFDA nod for antidepressant medication
As per IMS, Fluoxetine tablets have a market size of USD 23.9 million. This approval further strengthens the company's presence in the Fluoxetine portfolio, complementing the existing approval of Fluoxetine capsules, which has a market size of USD106 million, the Bengaluru based firm said.
Gland Pharma gets USFDA nod for generic breast cancer drug
Gland Pharma has received approval from the USFDA to market a generic medication for breast cancer treatment, Eribulin Mesylate Injection. It's expected to be the first generic approval in the market, with sales of around USD 92 million in the US.
Lupin gets USFDA nod to market generic medication
Lupin has gained approval from the USFDA to market generic Valbenazine Capsules, used to treat tardive dyskinesia. This medication is equivalent to Neurocrine Biosciences, Inc's Ingrezza Capsules. Lupin is among the first applicants for this generic drug, entitling them to 180 days of shared exclusivity.
Piramal Alternatives invests Rs 110 crore in Biodeal Pharmaceuticals
Piramal Alternatives invested Rs 110 crore in Noida-based Biodeal Pharmaceuticals through convertible instruments. The funding will enhance infrastructure, technology, and a nutraceuticals manufacturing facility. Biodeal is a key contract manufacturing player, specializing in nasal sprays and achieving PIC/S approval.
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