Skip to main content

MedPath Trial Home

Organizations News Research

Data Sources:ClinicalTrials.govEU CTRFDAEMANMPATGAHealth CanadaWHO ICTRP

MedPath Trial Home

Search trials. Track pipelines. Understand approvals. With AI-powered intelligence for clinical research.

Product

Clinical Trials
Drug Intelligence
Global Approvals
AI Research
Pricing

Resources

FAQ
Search

Company

News
About
Contact

Legal

Privacy Policy
Terms of Service

Disclaimer: This website provides information retrieval and data analysis services. The content does not constitute medical advice. Eligibility assessments are for reference only and should not replace consultation with qualified healthcare professionals. Data is sourced from public registries and regulatory agencies; MedPath does not guarantee completeness or accuracy. Always verify information with primary sources.

© 2026 MedPath Trial. All rights reserved.

We value your privacy

We use cookies to analyze site traffic and improve your experience. See our Privacy Policy.

Approvals/Philippines FDA/Zitabin-1000

Approved

STANDARD

Zitabin-1000

Bruck Pharma Private Limited🇵🇭 Food and Drug Administration - Philippines

Approval Date: Jul 14, 2025
Approval ID: f3a4648ea25075a2
Company: Bruck Pharma Private Limited
Type: Standard

Approval Details

Approval Id: f3a4648ea25075a2
Drug Approval Philippines Name: Zitabin-1000
Product Name: Zitabin-1000
Registration Number: DRP-13074-01
Brand Name: Zitabin-1000
Generic Name: Gemcitabine (as Hydrochloride)
Dosage Form: Lyophilized Powder for Injection (IV Infusion)
Dosage Strength: 1 g
Manufacturer: Bruck Pharma Private Limited
Importer: Nelpa Lifesciences, Inc.
Distributor: Kaufmann Pharma Inc
Issuance Date: 24 January 2023
Expiry Date: 28 November 2027
Classification: Prescription Drug (Rx)

Active Ingredients

Approved

Quick Info

Agency

Philippines FDA

Country

🇵🇭

Approval Date

Jul 14, 2025

Approval ID

f3a4648ea25075a2

Type

Standard

Back to Philippines FDA Approvals

Zitabin-1000 - Philippines FDA Drug Approval Details