USFDA
Realisation there in pharma industry to become self reliant in API production: IPA"Reliance on China for APIs is there...We had the technology of making all kinds of APIs but over a period of time we lost that advantage. ...
- Dr Reddy's launches stomach, esophagus problems treatment drug in the US
Quoting IQVIA Health data, Dr Reddy's said the Prevacid brand and generic had US sales of approximately USD 87 million for the most recent ...
- Lupin gets USFDA nod for generic drug
Drugmaker Lupin on Friday said it has received approval from the US health regulator to market Droxidopa capsules, used to treat dizziness....
- Aurobindo Pharma gets USFDA nod for generic Droxidopa capsules
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Droxidopa capsules in th...
- Zydus Cadila gets USFDA nod for low blood pressure drug
Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Droxidopa capsules in the st...
- Unichem Laboratories gets USFDA nod for plaque psoriasis treatment drug
Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for photot...
- Lupin, Aurobindo units recall products in US market
The drug is used to relieve mild to moderate pain and reduce fever. USFDA noted that Lupin has initiated the recall of the affected lot due...
- 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...
- Glenmark gets USFDA nod for acne treatment drug
Glenmark Pharmaceuticals has received final approval by the United States Food and Drug Administration (USFDA) for Clindamycin Phosphate Ge...
- Lupin gets USFDA to market generic anti-fungal cream in US market
The company has received approval from the US Food and Drug Administration (USFDA) to market its product, which is a generic version of Ana...
- Rhizen's cancer drug Umbralisib gets USFDA nod: Alembic Pharma
Alembic Pharma on Tuesday said its associate company Rhizen Pharmaceuticals AG's product Umbralisib, which was licensed to TG Therapeutics,...
- Alembic Pharma gets five observations from USFDA for Gujarat facility
As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any cond...
- Granules arm gets American health regulator's nod for Potassium Chloride Oral Solution
In a BSE filing, Granules said the US Food and Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed b...
- USFDA grants orphan drug designation to Zydus Cadila's Saroglitazar Mg
Zydus Cadila, which is a part of Cadila Group, said orphan drug designation provides eligibility for certain development incentives, includ...
- Unichem Labs gets USFDA nod to market generic capsules
The company has received abbreviated new drug application (ANDA) approval to market its Zonisamide capsules, USP 25 mg, 50 mg and 100 mg fr...
- Lupin gets USFDA nod to market generic Sevelamer Carbonate tablets
The product is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on...
- Zydus Cadila gets USFDA nod for thyroid drug
Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Liothyronine Sodium tablets USP, 5 mcg,...
- Rhizen receives USFDA orphan drug designation for cancer drug
The US Food and Drug Administration (USFDA) has granted orphan drug designation for Tenalisib (RP6530) for the treatment of patients with p...
- 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 th...
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