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Omnicure-1 - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
Omnicure-1
Approved
STANDARD
Omnicure-1
Atlanta Biologicals Pvt. Ltd.
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
e15e72a7154c8754
Company
Atlanta Biologicals Pvt. Ltd.
Type
Standard
Approval Details
Approval Id
e15e72a7154c8754
Drug Approval Philippines Name
Omnicure-1
Product Name
Omnicure-1
Registration Number
DRP-6013
Brand Name
Omnicure-1
Generic Name
Gemcitabine (as hydrochloride)
Dosage Form
Powder For Solution For Injection (I.V.)
Dosage Strength
1 g
Manufacturer
Atlanta Biologicals Pvt. Ltd.
Importer
Suhitas Pharmaceuticals, Inc.
Distributor
Suhitas Pharmaceuticals, Inc.
Issuance Date
25 May 2025
Expiry Date
24 February 2031
Pharmacologic Category
Antineoplastic
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
e15e72a7154c8754
Type
Standard
Back to Philippines FDA Approvals