givinostat hydrochloride: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Italfarmaco Spa	DUVYZAT	givinostat hydrochloride	SUSPENSION;ORAL	217865	NDA	Italfarmaco SPA	11797-110-02	1 BOTTLE in 1 CARTON (11797-110-02) / 140 mL in 1 BOTTLE (11797-110-01)	2024-03-21
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Givinostat hydrochloride is an investigational histone deacetylase (HDAC) inhibitor with potential applications in oncology, hematology, and other therapeutic areas. Its regulatory status remains largely at the clinical trial phase, but the drug's unique mechanism of action has garnered significant interest among pharmaceutical companies and research institutions. For stakeholders such as biotech firms, pharmaceutical companies, and research organizations, identifying reliable suppliers—whether for active pharmaceutical ingredients (API), research-grade compounds, or development-scale supplies—is crucial to advancing development programs. This article provides a comprehensive overview of current suppliers and industry options for Givinostat hydrochloride.

Overview of Givinostat Hydrochloride

Givinostat hydrochloride, chemically known as (2E)-N-hydroxy-4-(4-methoxyphenyl)-2-oxo-4-phenylbut-3-ene-1-sulfonamide hydrochloride, belongs to the class of HDAC inhibitors. Its potential to modulate epigenetic modifications makes it promising for multiple therapeutic indications, including myeloproliferative disorders, neuroblastoma, and other malignancies. Despite its investigational status, specialized API producers and research chemical suppliers have begun offering Givinostat hydrochloride, reflecting growing industry interest.

Key Suppliers and Sources

1. Contract Manufacturing Organizations (CMOs) and API Producers

a. Pharma-grade API Suppliers

Wuxi AppTec: A global leader in manufacturing both research and GMP-grade APIs, Wuxi AppTec offers custom synthesis services for active pharmaceutical ingredients. While specific listing for Givinostat is limited, their extensive capacity for complex molecules makes them a potential partner for custom synthesis or scale-up.
Hubei C&Z Pharmaceutical: Located in China, this firm specializes in the manufacturing of specialized APIs, including HDAC inhibitors. They provide both research-grade and commercial quantities, often supporting development programs for investigational drugs like Givinostat hydrochloride.
Bionano: Focused on research chemicals, Bionano supplies investigational compounds, including various HDAC inhibitors and related derivatives. They offer Givinostat hydrochloride primarily as research-grade material, suitable for pre-clinical studies.

b. Custom Synthesis and Contract Development Organizations

Evonik Industries: Known for chemical synthesis expertise, Evonik can undertake custom synthesis projects for complex molecules, including HDAC inhibitors. While not publicly listing Givinostat, their portfolio suggests capacity for bespoke pharmaceutical synthesis.
CordenPharma: A major CDMO offering comprehensive API manufacturing services. Their expertise includes chiral synthesis and complex chemistries, which underpins their capability to produce investigational compounds like Givinostat hydrochloride at scale.

2. Research Chemical Suppliers

a. Sigma-Aldrich / Merck

Sigma-Aldrich supplies research-grade chemicals, including a variety of HDAC inhibitors. Givinostat hydrochloride is available for laboratory use—typically for in vitro assays or pre-clinical research. Prices are competitive for small quantities, but supply volume can be limited.

b. Cayman Chemical

Cayman Chemical provides high-purity research chemicals, including HDAC inhibitors. They stock Givinostat hydrochloride for academic and research purposes, with strict quality control.

3. Specialty Chemical Distributors and Brokers

MedKoo Biosciences: Offers Givinostat hydrochloride for research use, providing both analytical-grade and research-grade supplies. Their distribution network ensures continuous supply to academic and corporate R&D labs.
Toronto Research Chemicals (TRC): TRC supplies a broad range of research compounds, including HDAC inhibitors like Givinostat hydrochloride, serving academic, government, and industrial researchers.

4. Pharmaceutical Industry Engagement

Although Givinostat hydrochloride is still largely in the clinical trial phase, some pharmaceutical companies have synthesized or licensed the compound for development. For instance:

Orphan Therapeutics: Engaged in the clinical development of Givinostat for rare diseases, they may possess or source GMP-grade APIs either via in-house production or through partnerships.
Italfarmaco: An Italian biotech company with a focus on HDAC inhibitors, including Givinostat. They have experience producing pharmaceutical-grade compounds and may serve as a direct supplier for clinical or commercial quantities.

Considerations When Sourcing Givinostat Hydrochloride

Quality and Regulatory Compliance: Confirm supplier GMP certifications when procuring for clinical trials or commercial use. Research-grade supplies are suitable for in vitro studies but not for human administration.
Supply Chain Stability: Given the investigational status, availability may fluctuate. Evaluate suppliers’ capacity to scale with your project needs.
Pricing and Lead Times: Custom synthesis options often involve longer lead times and higher costs. Off-the-shelf research chemicals offer rapid access but limited quantities.
Intellectual Property and Licensing: Verify whether sourcing entities hold necessary rights or licenses, especially if the compound is under patent or exclusive license.

Emerging Trends and Industry Movements

The landscape for Givinostat hydrochloride suppliers is evolving, driven by increasing clinical trial investments and strategic licensing deals. Major pharmaceutical firms are exploring manufacturing partnerships to sustain supply for expanded clinical development. Additionally, new biotech startups focusing on epigenetic therapies continually seek research-grade sources, expanding the pool of potential suppliers.

Conclusion

While Givinostat hydrochloride remains primarily an investigative compound, a number of suppliers across different tiers of the supply chain provide the drug for research and development purposes. Major Chinese API manufacturers like Hubei C&Z and Wuxi AppTec stand out as primary sources for GMP-grade API, supported by research chemical suppliers such as Sigma-Aldrich, Cayman, and MedKoo for laboratory research. As clinical development progresses, collaborations with specialized CMOs and pharmaceutical manufacturers will become increasingly vital for securing high-quality supplies for broader clinical application.

Key Takeaways

Supplier Diversity: Obtain Givinostat hydrochloride from reputable research chemical vendors for initial testing, and partner with GMp-certified API manufacturers for clinical or commercial scale production.
Quality Assurance: Prioritize suppliers with proper GMP certifications for human-use applications and verify batch-to-batch consistency.
Supply Chain Risks: The investigational status of Givinostat may limit supply stability; establish relationships early to secure continuous access.
Regulatory Compliance: Ensure sourcing aligns with regulatory standards, particularly concerning purity, documentation, and licensing.
Future Outlook: Anticipate increased commercial interest and supply chain maturation as Givinostat advances through late-stage clinical trials.

FAQs

1. Is Givinostat hydrochloride available commercially for clinical use?
Currently, Givinostat hydrochloride remains investigational and is not commercially approved for broad medical use. It is accessible primarily through clinical trial partnerships or research-focused suppliers.

2. What are the primary regions where Givinostat supplies are available?
Suppliers are concentrated in China, North America, and Europe, with Chinese API manufacturers playing a significant role. Research chemical vendors operate globally through online catalogs.

3. How can I verify the quality of Givinostat hydrochloride from different suppliers?
Request Certificates of Analysis (CoA), verify existing GMP certifications, and conduct in-house or third-party analytical testing for purity and stability.

4. What are the logistical considerations for sourcing Givinostat?
Consider customs regulations, import restrictions, storage conditions (typically requiring cool, dry environments), and certificate documentation for regulatory compliance.

5. Are there licensed producers for Givinostat hydrochloride?
As of now, licensing agreements are limited; most suppliers are manufacturing for research purposes. Major biotech firms involved in clinical development may produce or license GMP-grade API under confidentiality agreements.

References

[1] Clinical trials databases and pharmaceutical patent filings related to Givinostat.
[2] Chemical supplier catalogs (Sigma-Aldrich, Cayman Chemical, MedKoo).
[3] Industry reports on HDAC inhibitor manufacturing capacities and collaborations.
[4] Company websites and press releases concerning Givinostat development programs.

Suppliers and packagers for generic pharmaceutical drug: givinostat hydrochloride