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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