STRIDES PHARMA USFDA
Strides Pharma Science shares jump 9% after USFDA EIR for Bengaluru facility
Strides Pharma Science shares rise sharply on Thursday after the USFDA issued an Establishment Inspection Report (EIR) for its Bengaluru facility, concluding a recent cGMP inspection. The inspection ended with five observations, which the company addressed through corrective actions. The regulatory closure offers relief after the stock’s recent weakness.
Strides Pharma's Chestnut Ridge unit in New York classified as voluntary action indicated by USFDA
Strides Pharma Science announced its US subsidiary, Strides Pharma Inc, has received a Voluntary Action Indicated classification from the USFDA. This follows an inspection of its formulations unit in Chestnut Ridge, New York. The inspection covered Good Manufacturing Practices and drug-device combination capabilities. The facility supports the US market with various product types.
Strides Pharma Science gets USFDA nod for generic capsule to control triglyceride level
The product is bioequivalent and therapeutically equivalent to the reference listed drug Vascepa of Amarin. It will be manufactured at the company's facility in Bengaluru, it added. The Icosapent Ethyl capsules have a market size of around USD 1.3 billion, Strides said, citing IQVIA.
Strides Pharma arm gets USFDA tentative nod for generic HIV treatment drug
Strides Pharma Global, a subsidiary of Strides Pharma Science, has received tentative approval from the US FDA for its generic Dolutegravir tablets used in HIV treatment. The approval allows the company to participate in global donor-funded programs that procure the medicine.
Stelis Biopharma receives establishment inspection report from USFDA
This follows the abbreviated quality system inspection technique drug pre-approval on-site inspection specifically conducted by the US Food and Drug Administration (USFDA) for the drug-device combination products that are to be manufactured and commercialised at the site for the partner products by Stelis, it said in a regulatory filing.
Glenmark, Strides Pharma, Cipla recall products in the US
The USFDA noted in its report that the company, a subsidiary of Mumbai-based drug firm, is recalling the affected lot due to "blister package issues." The lot was produced at Glenmark's Pithampur (Madhya Pradesh) based manufacturing facility. The USFDA stated that Glenmark initiated the Class II nationwide (US) recall on June 29 this year.
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Strides Pharma recalls over 6 lakh bottles of blood pressure treatment tablets in US
As per the latest enforcement report by the US Food and Drug Administration (USFDA), the company, which is a unit of Bengaluru-headquartered Strides Pharma Science, is recalling 6,78,829 bottles of the blood pressure lowering drug in the US market.
Strides Pharma arm receives USFDA nod for potassium chloride oral solution
Strides Pharma Global, Singapore, has received approval for Potassium Chloride for Oral Solution USP, 20 mEq from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing.
Strides Pharma Science arm gets American drug regulator's nod for pain relieving drug
Strides Pharma Global Pte. Limited, Singapore, has received approval for Ibuprofen Oral Suspension USP, 100 mg/5 mL from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing.
Strides Pharma receives USFDA approval for Prednisone tablets
Strides Pharma Global Pte Limited, Singapore, has received approval for Prednisone tablets USP in the strengths of 10 mg and 20 mg from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing.
Strides Pharma gets USFDA nod for generic drug
Bengaluru-based Strides Pharma has 127 cumulative abbreviated new drug applications (ANDA) filings with USFDA of which 96 have been approved and 31 are pending approval.
Strides Pharma Science arm gets USFDA nod for HIV treatment drug
Drug firm Strides Pharma Science on Friday said its step-down wholly-owned subsidiary, Strides Pharma Global, has received approval from the US health regulator for Emtricitabine and Tenofovir Disoproxil Fumarate tablets, used to treat HIV.
Strides gets USFDA nod for generic Oxybutynin Chloride tablets
Company's step-down wholly owned subsidiary Strides Pharma Global Pte Ltd, Singapore, has received approval for Oxybutynin Chloride Tablets USP, 5 mg from the United States Food & Drug Administration (USFDA), Strides said in a filing to BSE.
Strides Pharma Science gets USFDA nod for Prednisone tablets
Strides Pharma Science Ltd on Monday said it has received approval from the US health regulator for its generic version of Prednisone tablets, prescribed for a variety of conditions, including allergies, respiratory illness and arthritis.
Strides Pharma Science arm gets USFDA nod for tension headache tablets
Strides Pharma Global Pte Ltd, Singapore, has received approval for Butalbital, Acetaminophen, and Caffeine tablets USP in the strengths of 50 mg/325 mg/40 mg from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing.
Strides Pharma gets USFDA nod for Ursodiol tablets, a liver disease treatment drug
Strides Pharma Science gets an approval from the USFDA to market Ursodiol tablets used for treating primary biliary cirrhosis, a progressive disease of the liver caused by a buildup of bile within the liver.
Strides Pharma gets USFDA nod to market generic headache drug
The product, which will be marketed by Singapore-based Strides Pharma Inc in the US market, is a generic version of Teva's Fioricet with Codeine capsules, it added.
Strides Pharma gets USFDA nod for generic ointment to treat skin conditions
Strides Pharma Science on Tuesday said it has received US health regulator's approval for its generic version of triamcinolone acetonide ointment used for treatment of various skin conditions.
Strides receives USFDA approval for Flucytosine Capsules
The product is a generic version of Ancobon Capsules, 250 mg and 500 mg, of Bausch Health US, LLC, the Bengaluru- headquartered pharmaceutical company said in a statement.
USFDA in active mode, issues obersvations to 4 drug makers in 3 days!
SMS Pharma today informed exchanges that the United States Food and Drug Administration (USFDA) conducted a cGMP inspection at Kandivalasa, Vipanagaram, Andhra Pradesh API manufacturing facility from January 13-17.
Strides arm receives EIR for its US facility
The facility is one of the very few manufacturing facilities in the US with a soft gel capsule (SGC) manufacturing suite for formulations with containment needs, the company said. Strides has a portfolio of approved SGCs in the US and other regulated markets.
Strides Pharma shares plunge 8% as company suspends sales of ranitidine tablets in US
On the National Stock Exchange, it cracked 7.94 per cent to close at Rs 302.60.
Strides Pharma suspends sale of Ranitidine tab in US
In a regulatory filing, the company said it has received an Information Request from the USFDA to provide test data related to NDMA impurities in ranitidine tablets.
USFDA recommends action against Strides Pharma Science Puducherry unit
The company believes that the classification will not have an impact on the current supplies and revenues from the facility," Strides Pharma said.
Strides gets USFDA nod to market laxative drug in US
The product will be manufactured at Strides' facility in Bengaluru and will be marketed by Strides Pharma in the US market.
Strides Pharma drops 3% on USFDA observation for Bengaluru plant
The observations are not material in nature, the company said.
Strides Shasun up over 3% on USFDA clearance
Strides Shasun is a vertically integrated global pharmaceutical company headquartered in Bengaluru.
Strides Shasun gets USFDA nod for HIV treatment drug
The product will be manufactured at the company's oral dosage facility at Bangalore and will be marketed by Strides Pharma Inc in the US market, it added.
Strides Shasun rallies 2% on USFDA drug approval
The company has 74 cumulative ANDA filings with the USFDA.
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