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Usfda

Zydus Gets Establishment Inspection Report From USFDA For Moraiya plant

The US Food and Drug Administration (USFDA) inspected the facility from July 26 to August 5, 2022, which concluded with four observations

07 November 2022

Lupin Gets USFDA Nod For Generic Drug To Treat Seizures

The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of rufinamide tablets of strengths 100 mg, 200 mg, and 400 mg


Zydus Gets USFDA Nod To Market Generic Antifungal Medication

Efinaconazole is an antifungal used for the topical treatment of Onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes


Cipla Q2 Net Profit Up 12% At Rs 797 Crore

The Mumbai-based drug maker had reported a consolidated net profit of Rs 709 crore in the July-September period of the previous fiscal

04 November 2022

Lupin Gets USFDA Nod For Generic Blood Pressure Lowering Drug

The Mumbai-based company said it has received the nod from the US Food and Drug Administration (FDA) to market Azilsartan Medoxomil tablets


Indian Pharma Industry May Rebound To 8-11% Growth Rate: Alkem

On the outlook for the US business, the world's largest pharmaceutical market, Alkem said led by new product launches and USFDA compliant manufacturing facilities, it is positive about its growth prospects there despite the...

11 July 2022

Glenmark Pharma

USFDA Issues Import Alert On Glenmark Pharma's Baddi Plant

The US Food and Drug Administration inspected the facility in June 2022 and subsequently placed it under "Official Action Indicated" status. 

27 October 2022

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Lupin Gets USFDA Nod For Generic Drug

The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Ivacaftor tablets, 150 mg strength.

08 June 2022

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06 June 2022
Zydus Gets USFDA Nod For Generic Antacid

Zydus Gets USFDA Nod For Generic Antacid

The company has received approval from the US Food and Drug Administration to market the drug in the strengths of 20mg and 40mg, the company said in a...


10 May 2022
Sun Pharma Gets Form 483 From USFDA For Regulatory Violations At Halol Plant

Sun Pharma Gets Form 483 From USFDA For Regulatory Violations At Halol Plant

The US Food and Drug Administration conducted a Good Manufacturing Practices (GMP) inspection of the Halol facility from April 26 to May 9, 2022, the...


09 May 2022
Glenmark Gets Tentative Approval From USFDA For Generic Psoriasis Foam

Glenmark Gets Tentative Approval From USFDA For Generic Psoriasis Foam

The tentative approval granted to Glenmark Pharmaceuticals Inc, USA (Glenmark) by the US Food & Drug Administration (USFDA) is for Calcipotriene and...


25 April 2022
Alembic Subsidiary Gets USFDA Nod For Plaque Psoriasis Treatment Foam 

Alembic Subsidiary Gets USFDA Nod For Plaque Psoriasis Treatment Foam 

The approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Clobetasol Propionate foam, 0.05 per...


24 April 2022
Aurobindo, Sun Pharma Recall Products In US Market

Aurobindo, Sun Pharma Recall Products In US Market

While Aurobindo Pharma is recalling Cyanocobalamin Injection, which is used to treat and prevent lack of vitamin B12, Mumbai-based Sun Pharma is recalling a...


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18 April 2022
Lupin Gets USFDA Nod To Market Generic Drug

Lupin Gets USFDA Nod To Market Generic Drug

The company has received tentative approval from the United States Food and Drug Administration for its abbreviated new drug application for Tenofovir...


07 April 2022
Lupin Launches Generic Contraceptive Drug In US

Lupin Launches Generic Contraceptive Drug In US

The Mumbai-based drug maker has launched the product in the US market under exclusive license, marketing and distribution agreement with Slayback Pharma LLC


24 March 2022
Lupin Gets USFDA Nod For Generic Product

Lupin Gets USFDA Nod For Generic Product

The Mumbai-based company's product is the generic version of Viatris Specialty LLC's Revatio


21 March 2022
Alembic Pharma Gets USFDA Nod For Lacosamide Tablet

Alembic Pharma Gets USFDA Nod For Lacosamide Tablet

The approval by the USFDA is for the abbreviated new drug application (ANDA) for Lacosamide Tablets of strengths 50 mg, 100 mg, 150mg, and 200 mg.


21 March 2022
Glenmark Pharmaceuticals Gets USFDA Nod For Lacosamide Tablet

Glenmark Pharmaceuticals Gets USFDA Nod For Lacosamide Tablet

The approval granted by the USFDA to the company's arm Glenmark Pharmaceuticals Inc, USA, is for Lacosamide tablets of strengths 50 mg, 100 mg, 150 mg, and 200...


11 March 2022
Strides Pharma Unit Gets USFDA For Generic Product

Strides Pharma Unit Gets USFDA For Generic Product

Singapore-based Strides Pharma Global Pte, a step-down wholly-owned subsidiary of the company, has received approval from the USFDA to market the product.


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08 February 2022
Lupin Gets USFDA Nod For Generic Version Of Arformoterol Tartrate Inhalation Solution

Lupin Gets USFDA Nod For Generic Version Of Arformoterol Tartrate Inhalation Solution

The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of arformoterol tartrate inhalation solution 15...


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