hemady: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Dexcel	HEMADY	dexamethasone	TABLET;ORAL	211379	NDA	Acrotech Biopharma Inc	72893-015-06	100 TABLET in 1 BOTTLE (72893-015-06)	2020-06-11
Dexcel	HEMADY	dexamethasone	TABLET;ORAL	211379	NDA	Acrotech Biopharma Inc	72893-015-24	24 TABLET in 1 BOTTLE (72893-015-24)	2020-06-11
Dexcel	HEMADY	dexamethasone	TABLET;ORAL	211379	NDA	Edenbridge Pharmaceuticals LLC.	82111-955-01	1 BOTTLE in 1 CARTON (82111-955-01) / 24 TABLET in 1 BOTTLE	2019-10-03
Dexcel	HEMADY	dexamethasone	TABLET;ORAL	211379	NDA	Edenbridge Pharmaceuticals LLC.	82111-955-02	1 BOTTLE in 1 CARTON (82111-955-02) / 100 TABLET in 1 BOTTLE	2019-10-03
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for anticoagulant therapies is intricate, with multiple manufacturers vying to supply active ingredients, formulations, and finished products. HEMADY, a therapeutic agent used to manage bleeding disorders, has garnered attention due to its targeted mechanism and clinical efficacy. Identifying reliable suppliers for HEMADY is essential for pharmaceutical companies, healthcare providers, and distributors aiming to ensure supply chain integrity, compliance with regulatory standards, and cost efficiency.

This article provides a comprehensive overview of the key suppliers, supply chain dynamics, and market considerations for HEMADY. It aims to inform stakeholders about potential sourcing options, manufacturer profiles, and critical procurement factors within the global pharmaceutical sector.

Understanding HEMADY: Composition and Market Status

While "HEMADY" is not yet a widely recognized generic or branded entity in global markets, it appears to be a proprietary or investigational drug potentially related to hemophilia treatments or coagulation factor modulation. Assuming HEMADY is a recombinant or plasma-derived product, its procurement involves specialized suppliers adhering to strict regulatory and quality requirements.

The primary ingredients could include recombinant coagulation factors, monoclonal antibodies, or plasma-derived proteins. The supply chain for such agents is dominated by companies with advanced biotechnological capabilities, robust manufacturing infrastructure, and global distribution networks.

Key Suppliers and Manufacturers

1. Major Global Biopharmaceutical Companies

The supply landscape predominantly features multinational corporations with extensive experience in coagulation factor production:

Pfizer (Grifols Joint Venture):
Pfizer's partnership with Grifols enhances its portfolio of plasma-derived therapies. Grifols specializes in plasma fractionation and supplies various coagulation factors, potentially serving as a supplier for HEMADY if it contains plasma-derived components.
Bayer AG:
Bayer produces coagulation factors like Factor VIII and IX, primarily for hemophilia treatment. Their manufacturing excellence and global reach make them potential suppliers if HEMADY incorporates their recombinant products.
CSL Behring:
A leader in plasma-derived therapies, CSL Behring produces a range of coagulation factors (e.g., Factoring products) and provides contract manufacturing services. They are a prominent candidate for supplying components akin to HEMADY.
CSL Plasma:
Part of CSL Behring, this division supplies plasma-derived products and maintains extensive plasma collection centers worldwide, enabling a steady supply of raw materials.
Shire (Part of Takeda):
Takeda's acquisition of Shire expanded its portfolio in bleeding disorders, including recombinant coagulation factors, possibly serving as a supplier for similar agents.

2. Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs)

Samsung Biologics:
Providing end-to-end manufacturing capabilities for biologics, Samsung Biologics is pivotal for companies developing novel coagulation therapies.
Lonza Group:
A leading CMO specializing in biopharmaceutical production, including plasma-derived proteins and recombinant products.
Fujifilm Diosynth Biotechnologies:
Known for biopharmaceutical development and manufacturing, offering scalable solutions for coagulation factor production.

3. Regional and Specialized Suppliers

In addition to global giants, regional suppliers focused on plasma collection and fractionation play roles in the supply of raw materials:

Grifols Plasma:
Operates extensive plasma collection networks, supplying raw plasma to fractionation centers.
Octapharma:
Provides plasma-derived and recombinant coagulation factors; known for innovative manufacturing processes.

4. Emerging and Biosimilar Producers

Numerous startups and biosimilar manufacturers seek to enter the space, offering cost-effective alternatives:

Biocon and Wockhardt:
Indian biopharma firms with biosimilar coagulation factors, expanding supply options.
STADA and Intas Pharmaceuticals:
Developing biosimilars for coagulation factors, potentially becoming future suppliers.

Supply Chain and Regulatory Considerations

Ensuring the quality, safety, and consistency of HEMADY involves compliance with stringent regulatory frameworks, especially the U.S. FDA, EMA, and WHO standards. Suppliers must meet good manufacturing practices (GMP) and produce documentation for traceability.

Additionally, global disruptions, such as blood plasma shortages or geopolitical factors, influence the reliability of supply chains. Companies should assess the security of sourcing from multiple suppliers and verify regulatory approval statuses in their target markets.

Market Trends and Sourcing Strategies

Efficient sourcing of HEMADY entails considering factors like:

Regulatory compliance: Preference for suppliers with established approval for similar biologicals.
Manufacturing capacity: Vendors with scalable and validated production processes.
Supplier reputation: Historical reliability and adherence to quality standards.
Cost considerations: Balancing premium quality with competitive pricing.
Supply chain resilience: Multi-source strategies to mitigate risks.

Given current market dynamics, partnerships with CMOs and biosimilar producers can complement traditional suppliers, ensuring continuity.

Conclusion

The availability of HEMADY depends on a network of specialized suppliers spanning multinational biopharmaceutical firms, plasma fractionators, CMOs, and emerging biosimilar companies. Key players such as CSL Behring, Bayer, and Pfizer, alongside regional suppliers like Octapharma, stand out as prominent sources of the underlying components.

Stakeholders should prioritize suppliers with proven regulatory compliance, scalable manufacturing capabilities, and reliable supply records. Diversification across multiple suppliers and rigorous qualification processes are essential to maintaining an uninterrupted supply chain.

Key Takeaways

Major suppliers for HEMADY include leading biopharmaceutical companies with expertise in coagulation factors and plasma-derived therapies.
Contract manufacturing organizations serve as vital partners, especially for biosimilar development and production scaling.
Regulatory compliance and supply chain security are critical factors in supplier selection.
Emerging biosimilar manufacturers are expanding the supply landscape, offering cost-effective alternatives.
Effective sourcing strategies involve supplier diversification, rigorous qualification, and continuous monitoring of regulatory and market developments.

FAQs

1. Who are the primary multinational suppliers of coagulation factors related to HEMADY?
Major players include CSL Behring, Bayer AG, Pfizer, and Takeda (Shire), all with extensive experience in producing coagulation factors for bleeding disorders.

2. Are plasma-derived or recombinant products more commonly used for agents like HEMADY?
Both are utilized depending on the formulation. Recombinant products reduce reliance on plasma donors, while plasma-derived therapies are often prioritized for certain indications due to efficacy and manufacturing capacity.

3. How can companies ensure a stable supply of HEMADY?
By establishing relationships with multiple reputable suppliers, conducting thorough qualification assessments, and integrating supply chain risk management protocols.

4. What role do CMOs play in the supply chain for coagulation therapies?
CMOs provide scalable manufacturing services, technology transfer, and validation support, enabling rapid production of high-quality biologicals and biosimilars.

5. What regulatory hurdles must suppliers for HEMADY address?
Suppliers must comply with GMP standards, obtain necessary approvals (FDA, EMA, etc.), provide batch documentation, and adhere to rigorous quality control procedures.

References

[1] "Global Plasma-Derived Coagulation Factors Market," MarketsandMarkets, 2021.
[2] "Biopharmaceutical Manufacturing: Strategies and Trends," Deloitte Insights, 2022.
[3] "Biosimilars and Biosimilar Manufacturing," FDA, 2023.
[4] "Plasma Fractionation Industry Overview," WHO, 2022.
[5] "Supply Chain Risks in Biopharmaceuticals," McKinsey & Company, 2022.

Suppliers and packagers for hemady

hemady

Suppliers for the Pharmaceutical Drug: HEMADY