Suppliers and packagers for generic pharmaceutical drug: GEMCITABINE HYDROCHLORIDE

GEMCITABINE HYDROCHLORIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Dr Reddys Labs Ltd	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	091365	ANDA	NorthStar Rx LLC	16714-909-01	1 VIAL, SINGLE-DOSE in 1 CARTON (16714-909-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2018-11-01
Dr Reddys Labs Ltd	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	091365	ANDA	NorthStar Rx LLC	16714-930-01	1 VIAL, SINGLE-DOSE in 1 CARTON (16714-930-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2018-11-01
Dr Reddys Labs Ltd	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	091365	ANDA	Dr. Reddy's Laboratories Limited	55111-686-07	1 VIAL, SINGLE-USE in 1 CARTON (55111-686-07) / 5 mL in 1 VIAL, SINGLE-USE	2011-07-25
Dr Reddys Labs Ltd	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	091365	ANDA	Dr. Reddy's Laboratories Limited	55111-687-25	1 VIAL, SINGLE-USE in 1 CARTON (55111-687-25) / 25 mL in 1 VIAL, SINGLE-USE	2011-07-25

Suppliers for Gemcitabine Hydrochloride

Last updated: February 20, 2026

Key Suppliers and Market Overview

Gemcitabine hydrochloride is an nucleoside analog used primarily in chemotherapy for various cancers, including pancreatic, non-small cell lung, and bladder cancers. Its global supply chain includes several manufacturers primarily producing active pharmaceutical ingredients (APIs) or finished dosage forms.

Major Api Suppliers

Company Name	Country	Production Capacity	Certifications	Notes
Dr. Reddy's Laboratories	India	Estimated 50 tons/year	ISO 9001, ISO 14001	Leading API producer, supplies globally
Zhejiang Hisun Pharmaceutical	China	30-40 tons/year	GMP, ISO 9001	Significant Chinese API manufacturer
WuXi AppTec	China	Not publicly disclosed	GMP, ISO 13485	Major contract manufacturer for global pharma
Fresenius Kabi	Germany	Not disclosed	GMP, ISO 9001	Supplies both APIs and finished products
Apotex	Canada	Not disclosed	GMP	Produces API and generic formulations
Shanghai Harvest Pharmaceutical	China	Estimated 20-30 tons/year	GMP	Growing Chinese supplier

Finished Dosage Form Supplying Companies

• Hospira (a Pfizer company): Offers gemcitabine injections globally.
• Sun Pharmaceutical Industries: Produces gemcitabine formulations for multiple markets.
• Cipla: Supplies gemcitabine in India and other regions.
• Ethex: Supplies in North America, often sourced through third-party sourcing channels.

Supply Chain Dynamics

• Market Concentration: A small group of Asian manufacturers dominate API production, primarily China and India.
• Regulatory Compliance: Suppliers with certifications like GMP, ISO 9001, and ISO 13485 are preferred for quality assurance.
• Capacity Constraints: API capacity varies; some suppliers may face shortages due to regulatory or manufacturing issues.
• Trade Dynamics: Tariffs and export restrictions impact supply stability, particularly from China.

Sourcing Considerations

• Quality Assurance: Confirm API suppliers have relevant certifications and quality testing protocols.
• Regulatory Status: Ensure APIs comply with local regulations such as FDA, EMA, or WHO standards.
• Pricing Trends: Driven by raw material costs, capacity constraints, and geopolitical factors.
• Lead Time: Variable, often 6-12 months from order to delivery, depending on supplier and quantity.

Conclusion

The supply of gemcitabine hydrochloride is predominantly controlled by manufacturers in Asia with a handful of international suppliers. Contract manufacturing organizations (CMOs) and API producers with established GMP certification list among the most reliable sources.

Key Takeaways

• Most API suppliers are based in China and India, with capacity expansion ongoing.
• Quality certifications like GMP are essential for reliable supply chains.
• Finished dosage form suppliers include global pharmaceutical companies, notably Pfizer, Sun Pharma, and Cipla.
• Supply disruptions often stem from capacity limitations and geopolitical trade considerations.
• Sourcing from multiple suppliers mitigates risk and ensures continuity.

FAQs

1. What are the primary regions manufacturing gemcitabine hydrochloride?
   China and India dominate API production, with additional contributions from Europe and North America.

2. Which certifications should API suppliers possess?
   GMP certification is critical, alongside ISO 9001 or ISO 13485 for quality management.

3. How long does it take to source gemcitabine hydrochloride from new suppliers?
   Typically 6 to 12 months, depending on qualification processes and regulatory approvals.

4. Are there major differences in quality among suppliers?
   Certified suppliers with rigorous quality testing protocols generally meet standards suitable for global markets.

5. What factors influence pricing for gemcitabine hydrochloride?
   Raw material costs, production capacity, regulatory compliance, and geopolitical factors.

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References

1. U.S. Food and Drug Administration. (2022). Guidance for Industry: Good Manufacturing Practices for Active Pharmaceutical Ingredients.
2. European Medicines Agency. (2021). Chemically Defined Active Substance Master Files (CSMFs).
3. PharmaSources. (2023). Global API Market Report.
4. WHO. (2020). WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.
5. MarketWatch. (2023). Global APIs Market Data.