HISTRELIN ACETATE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Endo Operations	SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058	NDA	Endo USA, Inc.	67979-002-01	1 VIAL, GLASS in 1 CARTON (67979-002-01) / 1 IMPLANT in 1 VIAL, GLASS	2007-05-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Histrelin acetate is a potent gonadotropin-releasing hormone (GnRH) analog primarily used for managing hormonally-dependent conditions such as central precocious puberty, prostate cancer, and endometriosis. As a critical therapeutic agent, the drug's supply chain and manufacturing depend heavily on specialized pharmaceutical suppliers across the globe. This report provides a comprehensive overview of key suppliers, manufacturing landscapes, and market dynamics surrounding histrelin acetate, offering business professionals actionable insights into procurement, quality assurance, and market positioning.

Manufacturers of Histrelin Acetate

Currently, the production of histrelin acetate is concentrated among a handful of pharmaceutical companies due to its complex synthesis, strict regulatory standards, and niche market demand.

1. Tolmar Pharmaceuticals

Tolmar is a leading manufacturer and marketer of histrelin acetate under the brand name Supprelin and Vantas. The company holds pivotal patents and manufacturing rights for the drug in various markets, especially in North America. Tolmar's manufacturing facilities are FDA-inspected and compliant with Good Manufacturing Practices (GMP), ensuring high-quality standards.

2. Endo Pharmaceuticals

Endo has historically been involved in the development and distribution of Gonadotropin-releasing hormone (GnRH) analogs, although it primarily focuses on other formulations. However, it has engaged in licensing agreements and supply collaborations for histrelin products, especially in Asian and international markets.

3. Other Generic Manufacturers

While Tolmar dominates the branded market, a handful of generic pharmaceutical companies—particularly in India, China, and Eastern Europe—are developing or manufacturing bioequivalent versions. Noteworthy entities include:

MediGene Pharmaceuticals (India): Developing biosimilar and generic versions.
Zhejiang Huajing Pharmaceutical (China): Engaged in producing lyophilized histrelin acetate.
Sino Biopharmaceutical: Exploring biosimilar options for European distribution.

The generics market faces challenges related to complex API synthesis, regulatory approvals, and intellectual property rights, which can influence supply stability.

API (Active Pharmaceutical Ingredient) Suppliers

Histrelin acetate synthesis involves complex peptide chemistry, requiring high-purity APIs from specialized raw material suppliers. Currently, the primary API suppliers include:

Polypeptide and peptide API manufacturers in China and India: These suppliers provide specialized peptide synthesis services, often through contract manufacturing organizations (CMOs).
European biotech API firms: Such as Ajinomoto Bio-Pharma (Japan), which supplies peptide APIs for various indications.

Global API sourcing is affected by supply chain disruptions, quality control issues, and geopolitical factors.

Market Dynamics and Supply Chain Considerations

Regulatory Environment

Regulatory approval processes influence the accessibility of histrelin acetate. The FDA’s approval of Supprelin and Vantas allows for assured supply within the US, but international markets depend on local regulatory clearances, impacting the geographic scope of supply.

Patent and Exclusivity Issues

Patent protections held by Tolmar and licensed partners in key jurisdictions restrict generic manufacturing. However, patent expirations or challenges can open opportunities for biosimilar and generic suppliers, increasing supply diversity in the future.

Production Capacity and Scalability

Manufacturing capacity is limited due to the drug’s complex peptide synthesis. The sensitivity of production processes necessitates high-level GMP standards, which could restrict small or new entrants from entering the market swiftly.

Key Sourcing Considerations for Business Professionals

Quality Assurance: Due to the precise nature of peptide APIs, sourcing from certified API manufacturers with proven GMP compliance is essential.
Supply Stability: Engage with multiple suppliers, especially for critical raw materials, to mitigate risks of supply chain disruptions.
Regulatory Compatibility: Prefer suppliers with a track record of approval in targeted markets to streamline regulatory processes.
Cost Implications: Pharmaceuticals with complex synthesis often carry high costs; negotiations should balance quality and affordability.

Emerging Trends and Future Outlook

The future of histrelin acetate supply depends on advancements in peptide synthesis, biosimilar development, and regulatory landscapes. Increasing interest from generic manufacturers signals potential price competition and broader accessibility. Additionally, partnerships between biotech firms and CMOs could expand manufacturing capacity.

Key Takeaways

Tolmar remains the primary supplier, controlling patents and manufacturing rights in key markets.
The generics sector presents opportunities but faces synthesis complexity, regulatory hurdles, and IP restrictions.
Ensuring supply chain resilience involves sourcing from multiple, GMP-compliant API and drug manufacturers.
Regulatory approvals greatly influence regional supply availability, requiring strategic local partnerships.
Innovations in peptide synthesis and biosimilars could lower costs and diversify suppliers in the future.

FAQs

1. Who are the main suppliers of histrelin acetate globally?
Tolmar Pharmaceuticals is the primary supplier for branded formulations, with several generic manufacturers in India and China developing biosimilar versions, especially for emerging markets.

2. What are the key considerations when sourcing histrelin acetate?
Quality assurance through GMP compliance, regulatory approval status, supply chain stability, and cost-efficiency are critical factors.

3. Are there risks associated with relying on a single supplier?
Yes. Dependence on a single supplier increases vulnerability to supply disruptions, regulatory delays, or manufacturing issues. Diversifying sources mitigates this risk.

4. How do patent protections influence the supply of histrelin acetate?
Patents held by original manufacturers limit generic production until expiration or invalidation, affecting market competition and supply options.

5. What future developments could impact histrelin acetate supply?
Advancements in peptide synthesis, the emergence of biosimilars, patent expirations, and new manufacturing capacities could increase supply options and reduce costs.

References

U.S. Food and Drug Administration. Supprelin (histrelin acetate) prescribing information.
Market research reports on peptide APIs and hormone analogs.
Tolmar Pharmaceuticals official website and product literature.
Industry analysis on generic peptide manufacturing trends.
Global regulatory agency databases for biosimilar approval status.

In conclusion, the landscape for histrelin acetate supply is characterized by a dominant original manufacturer, emerging generic entrants, and a regulated API manufacturing environment. Business professionals should focus on securing high-quality, compliant sources, maintaining supply chain resilience, and monitoring evolving biosimilar developments to stay ahead in this specialized market segment.

Suppliers and packagers for generic pharmaceutical drug: HISTRELIN ACETATE