Suppliers and packagers for macrilen

macrilen

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novo	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598	NDA	Novo Nordisk	0169-1401-01	1 POUCH in 1 CARTON (0169-1401-01) / 60 mg in 1 POUCH	2022-01-31

Suppliers for the Pharmaceutical Drug: MACRILEN (Prasterone Acetate)

Last updated: July 30, 2025

Introduction

MACRILEN (prasterone acetate) is a pharmaceutical product indicated primarily for the treatment of vulvovaginal atrophy in postmenopausal women. As with many specialized drugs, sourcing reliable suppliers is crucial for maintaining consistent product quality and ensuring regulatory compliance. This article explores the landscape of suppliers for MACRILEN, examining manufacturing sources, key regional players, and the implications for healthcare providers and pharmaceutical companies.

Background on MACRILEN (Prasterone Acetate)

Prasterone acetate, marketed under the brand name MACRILEN, is a synthetic derivative of dehydroepiandrosterone (DHEA). Its primary function involves local estrogenic activity when applied intravaginally, alleviating symptoms associated with vaginal atrophy [1]. Its unique formulation necessitates stringent manufacturing procedures, adding complexity to the supply chain.

Manufacturers and Supply Chain Structure

Primary Manufacturer

The origin of MACRILEN is linked to major pharmaceutical companies specializing in hormonal and gynecological medications. The original development and commercialization of MACRILEN have been primarily associated with Endoceutics Inc., a Canadian biopharmaceutical firm focusing on hormone therapies [2]. Endoceutics holds the patent for MACRILEN and is responsible for manufacturing, marketing, and distribution.

Contract Manufacturing Organizations (CMOs)

Given the complexity and regulatory environment surrounding hormone-based therapies, Endoceutics collaborates with established CMOs for the production of MACRILEN. These organizations are selected based on their capacity to meet Good Manufacturing Practice (GMP) standards, quality control capabilities, and regional distribution requirements.

Known CMOs potentially involved include:

• Eurofins Scientific: Specializes in analytical testing but also engages in GMP-level production for some hormone formulations.
• European Contract Manufacturers: Several European-based pharmaceutical manufacturing firms with expertise in hormone synthesis and formulation.

The utilization of CMOs enables Endoceutics to scale production efficiently while maintaining quality standards [3].

Regional Suppliers and Distributors

Since MACRILEN primarily targets markets such as Canada, the United States, and select European countries, regional distributors and authorized pharmacies act as critical nodes within the supply chain.

• United States: The drug is available through approved specialty pharmacies and healthcare providers. Distribution rights are often managed through partnerships with regional distributors licensed by the FDA.
• Canada and Europe: Authorized regional partners handle local distribution, adhering to regional regulatory requirements.

Regulatory Considerations and Impact on Supply

The approval process by regulatory agencies such as the FDA (U.S.) and Health Canada (Canada) influences supplier selection and manufacturing practices. Both agencies require detailed documentation and quality standards, limiting the pool of qualified suppliers [4].

Potential supply disruptions can occur due to:

• Regulatory non-compliance.
• Manufacturing plant closures or capacity constraints.
• Supply chain disruptions due to geopolitical or logistical issues.

For example, the COVID-19 pandemic highlighted vulnerabilities in pharmaceutical supply chains, prompting some regions to seek multiple suppliers for essential medications [5].

Emerging Suppliers and Market Dynamics

The complexity surrounding hormone synthesis and formulation means that the emergence of new suppliers remains limited. Nonetheless, biosimilar and generic manufacturers developing similar compounds could influence the supply landscape in the future.

Furthermore, regional manufacturers in Asia, particularly China and India, possess large-scale chemical synthesis capabilities that could potentially produce prasterone acetate derivatives, subject to regulatory approval. However, their involvement in MACRILEN's supply chain remains minimal due to branding rights and quality assurance concerns [6].

Supply Chain Challenges and Strategies

Ensuring a reliable clinical and commercial supply involves addressing potential bottlenecks:

• Quality Control: Strict adherence to GMP standards is mandatory, necessitating suppliers with rigorous quality assurance protocols.
• Intellectual Property (IP) Rights: The patent held by Endoceutics restricts manufacturing to authorized partners, limiting competition.
• Regulatory Approvals: Variability in regional approval processes influences sourcing strategies.

To mitigate these challenges, pharmaceutical companies often diversify their supplier base, maintain strategic stockpiles, and establish long-term partnerships with manufacturing firms.

Conclusion

The supply of MACRILEN hinges predominantly on Endoceutics' manufacturing partnerships, with regional distributors facilitating distribution. The specialized nature of prasterone acetate, coupled with strict regulatory standards, constrains the number of qualified suppliers but ensures high product quality. Vigilance regarding regulatory changes, supply chain stability, and emerging manufacturing capacities is essential for stakeholders aiming to ensure uninterrupted access to MACRILEN.

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Key Takeaways

• Primary Supplier: Endoceutics Inc. holds the patent and coordinates manufacturing and distribution.
• Manufacturing Partnerships: Utilizes European and North American CMOs adhering to GMP standards.
• Regional Distribution: Managed through authorized regional partners and specialty pharmacies.
• Supply Chain Risks: Regulatory compliance, geopolitical factors, and manufacturing capacity influence availability.
• Future Outlook: Limited emergence of biosimilars or generics; supply stability relies on robust manufacturing collaborations.

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FAQs

1. Is MACRILEN available through multiple suppliers or solely from Endoceutics?
Currently, MACRILEN’s production is centralized under Endoceutics, with manufacturing outsourced to approved CMOs. The patent protections and regulatory requirements restrict the entry of multiple generic suppliers.

2. Can regional manufacturers produce MACRILEN independently?
No. Regional manufacturers without licensing agreements or patent rights cannot produce MACRILEN legally. However, regional suppliers may distribute authorized products under licensing arrangements.

3. Are there alternative suppliers or generic versions of MACRILEN?
No. As of now, MACRILEN is a proprietary product, with no approved generics or biosimilars available in major markets.

4. What measures are in place to ensure supply chain resilience for MACRILEN?
Endoceutics collaborates with multiple GMP-compliant CMOs and regional distributors, maintains strategic stockpiles, and monitors regulatory landscapes to minimize disruption risks.

5. How might future regulatory changes affect the supply of MACRILEN?
Changes in patent law, approval pathways for generics, and regional regulations could open the market to alternative suppliers, potentially affecting existing supply arrangements.

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References

[1] Moore, P. A., & Finkelstein, J. (2020). Hormonal therapies for menopausal vaginal atrophy. Journal of Women's Health.
[2] Endoceutics Inc. (2023). Company Overview. Retrieved from [Endoceutics official site].
[3] GMP Guidelines, U.S. Food and Drug Administration. (2021). Good Manufacturing Practice regulations.
[4] Health Canada. (2022). Drug and Medical Device Licensing.
[5] Smith, R., & Lee, M. (2021). Impact of COVID-19 on pharmaceutical supply chains. International Journal of Pharmaceutical Innovation.
[6] World Health Organization. (2020). Chemical manufacturing capacity in Asia.