usfda
Pharma Firm Ipca Labs' Plant Gets 3 Observations From US Drugs Regulator
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The observations were followed by the USFDA inspection at the site from April 18 to April 26 Read more
Zydus Lifesciences Gets Nod From USFDA For Metronidazole Topical Cream
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The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad Read more
Booster Dose: Zydus Likely To Arm India With Single-dose Malaria Drug
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In Phase-2 trials now, pill also works against drug-resistant malaria strains Read more
Global Pharma Recalls 50,000 Tubes Of Contaminated Eye Drops In US: USFDA
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Global Pharma Healthcare is recalling 50,000 tubes of eye drops in the US market due to bacterial contamination, accordi... Read more
Glenmark Gets USFDA Nod For Generic Drug With 180-day Exclusivity
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Glenmark Pharmaceuticals on Thursday said it has received an approval from the US health regulator to market a generic m... Read more
Glenmark Gets USFDA Nod To Market Generic Medication To Treat Schizophrenia
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Glenmark Pharmaceuticals on Monday said it has received approval from the US health regulator to market a generic produc... Read more
USFDA Issues Form-483 With 1 Observation To Torrent Pharma
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USFDA conducted the pre-approval inspection of the Torrent Pharma Bileshwarpura-based plant from March 13-March 17. Read more
Marksans Pharma Gets USFDA Nod For Generic Version Of Famotidine Tablets
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Marksans Pharma Ltd on Friday said it has received final approval from the US health regulator for its generic version o... Read more
USFDA Issues 8 Observations For Cipla's Pithampur Manufacturing Facility
World - Published date: .
USFDA conducted a Good Manufacturing Practices (cGMP) inspection at Cipla's Pithampur manufacturing facility from 6-17 F... Read more
Sun Pharma Gets US Health Regulator Nod To Market Generic Medication
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Sun Pharmaceutical Industries on Friday said its subsidiary has received approval from the US health regulator to market... Read more
Alkem Launches Novel Antibiotic Combination For Drug-resistant Infections
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The formulation, to be sold under the Zidavi brans for Rs 2,700 a vial, has been approved by US FDA, European Medicines ... Read more
USFDA Issues Warning Letter To Lupin For Maharashtra-based API Plant
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The US health regulator has pulled up drug maker Lupin for manufacturing lapses, including failure to establish adequate... Read more
Glenmark Pharma Gets US Health Regulator Nod For Generic Medication
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Glenmark Pharmaceuticals on Wednesday said it has received approval from the US health regulator to market Sodium Phenyl... Read more
USFDA Issues Import Alert On Glenmark Pharma's Baddi Manufacturing Plant
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Glenmark Pharmaceuticals on Wednesday said the US health regulator has put its manufacturing plant at Baddi under import... Read more
Alembic Pharma Gets USFDA Approval To Market Pirfenidone Tablets
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Alembic Pharmaceuticals said it has received approval from the US health regulator to market Pirfenidone tablets used to... Read more
Sun Pharma's Halol Unit Gets 10 Observations Under USFDA's Form 483
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Plant's OAI status is unchanged, hinting at status quo; Sun Pharma says will respond to observations within 15 days Read more
Lupin's Goa Plant Gets 7 Observations From USFDA, Firm Unperturbed
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Says confident of resolving matter, does not share nature of observations Read more
Zydus Cadila Gets USFDA Nod To Market Depression Treatment Drug In US
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Drug firm Zydus Cadila on Saturday said it has received approval from the US health regulator to market Vortioxetine Tab... Read more
Zydus Cadila Gets USFDA Nod For Arthritis Drug With 180-days Exclusivity
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Drug firm Zydus Cadila said it has received final approval from the US health regulator to market Tofacitinib extended-r... Read more
Zydus Cadila Gets USFDA Final Nod For Low Blood Pressure Drug Droxidopa
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The newly approved medication will be manufactured at the group''s formulation manufacturing facility at SEZ, Ahmedabad Read more