Bulk Pharmaceutical API Sources for MACIMORELIN ACETATE

Bulk Pharmaceutical API Sources for MACIMORELIN ACETATE

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-14820A
Starshine Chemical		2023-05-5H00882
AbaChemScene		CS-0027172
EvitaChem		evt-274660
BOC Sciences		945212-59-9

Bulk Active Pharmaceutical Ingredient (API) Sources for: MACIMORELIN ACETATE

Last updated: July 28, 2025

Introduction

Macimorelin acetate, marketed as Macrilen®, is an oral growth hormone secretagogue approved by the FDA for diagnosing adult growth hormone deficiency (AGHD). As an orally active ghrelin receptor agonist, it stimulates growth hormone (GH) secretion, providing a valuable diagnostic tool. The demand for high-quality bulk Macimorelin acetate API is increasing among pharmaceutical companies, contract manufacturing organizations (CMOs), and research institutions. Sourcing reliable, compliant suppliers with consistent product quality forms the foundation for clinical research, manufacturing, and commercialization.

This report evaluates the principal sources of bulk Macimorelin acetate API, emphasizing supplier reputation, regulatory compliance, manufacturing capacity, quality standards, and geographic distribution.

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Overview of API Manufacturing and Supply Chain

The global API supply chain is characterized by a network of chemical manufacturers across Asia, Europe, and North America. Asian producers—primarily based in China and India—dominate high-volume NME (new molecular entity) APIs due to cost advantages and manufacturing expertise. European and North American suppliers tend to emphasize regulatory compliance, quality assurance, and shorter supply chains for specialty APIs.

For Macimorelin acetate, key considerations include compliance with Good Manufacturing Practices (GMP), robust analytical testing, stability profiles, and reliable delivery timelines.

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Major API Suppliers for Macimorelin Acetate

1. Chinese API Manufacturers

China remains the leading source of APIs globally, owing to its extensive manufacturing infrastructure and competitive pricing. Several Chinese companies have established facilities capable of producing Macimorelin acetate to international standards.

• Jiangsu Hengrui Medicine Co., Ltd.

  Hengrui is known for its diverse portfolio of pharmaceutical APIs and intermediates. While primarily focused on oncology and anti-diabetic agents, they expand into specialty APIs including growth hormone secretagogues. Their facilities adhere to ISO 9001 and GMP standards, and they have attained certifications from the China Food and Drug Administration (CFDA). Their capacity for large-scale production and quality assurance mechanisms make them a key candidate.

• Hangzhou Bioking Biochemical Co., Ltd.

  Specializing in customized API manufacturing, Bioking offers synthetic APIs including select GH secretagogues. Their manufacturing processes involve advanced chemical synthesis, ensuring high purity levels (>99%) suitable for clinical and commercial use. They demonstrate compliance with international standards and have export experience to regulated markets.

• 浙江康恩贝药业股份有限公司 (Zhejiang Konka Pharmaceutical Co., Ltd.)

  This company supports Chinese and international clients with synthetic APIs. Their significant capacity for small molecule APIs, coupled with rigorous quality controls, positions them as a potential bulk source of Macimorelin acetate, especially for early-phase clinical materials.

2. Indian API Manufacturers

India’s API manufacturing sector is renowned for robust quality controls, cost competitiveness, and extensive experience in complex small molecules.

• Granules India Ltd.

  A WHO-GMP certified manufacturer, Granules India supplies various APIs and intermediates globally. The company emphasizes quality, with comprehensive analytical testing and regulatory compliance, making it a credible source for Macimorelin acetate.

• Hetero Drugs Ltd.

  With a diversified product portfolio, Hetero’s facilities meet global standards, including USFDA, EU-GMP, and WHO-GMP certifications. They possess strong capabilities for custom synthesis and high-volume production.

• Biological E Limited

  While primarily focused on biopharmaceuticals, they have ventured into small molecule APIs and intermediates for niche therapies. Their experienced R&D team aids in the synthesis of complex molecules like Macimorelin acetate.

3. European API Producers

European API manufacturers emphasize stringent regulatory compliance and high-quality standards.

• Novartis API Production Sites (Switzerland, Germany)

  Major pharmaceutical companies like Novartis maintain internal API production capabilities for specialty compounds, including GH secretagogues, for their proprietary pipelines and external clients through licensing or custom synthesis agreements.

• Quality Chemical Suppliers (e.g., Evonik Industries, Solvay)

  These companies supply advanced intermediates and specialty APIs, often under strict regulatory oversight, though their direct involvement with Macimorelin acetate remains limited. Collaborations or licensing agreements could facilitate access.

4. North American Suppliers

North America has a smaller but notable presence of API manufacturers focused on high-quality, regulated products.

• Patheon (Thermo Fisher Scientific)

  Offers GMP manufacturing services for APIs and finished drug products. While specific to client projects, their facilities support complex API synthesis suitable for clinical trial use.

• Carbogen Amcis

  Specializing in custom synthesis and contract manufacturing of small molecule APIs, Carbogen Amcis has facilities compliant with FDA and EMA standards, with the capacity to produce Macimorelin acetate for clinical research.

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Criteria for Selecting Bulk API Sources

When sourcing Macimorelin acetate API, consider:

• Regulatory Compliance: Suppliers must hold GMP certification aligning with FDA, EMA, or other relevant authorities. Their manufacturing processes, analytical test methods, and documentation should comply with current Good Manufacturing Practices.

• Product Purity and Quality: API should meet or exceed >99% purity. Certificates of Analysis (CoA), stability data, and impurity profiles are critical for formulation and clinical testing.

• Manufacturing Capacity and Lead Times: Reliable suppliers demonstrate scalable capacity, consistent output, and predictable delivery schedules for both small and large orders.

• Transparency and Documentation: Traceability of raw materials, synthesis pathways, batch records, and adherence to quality control protocols.

• Cost and Payment Terms: Competitive pricing aligned with product quality and delivery schedules, with clear contractual terms.

• Intellectual Property Compliance: Ensure suppliers do not infringe on patented synthesis routes, particularly if the product is intended for commercialization.

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Regulatory and Quality Considerations

Suppliers for Macimorelin acetate must provide comprehensive documentation, including CoA, Analytical Method Validation, stability data, and potentially raw material certifications. For clinical or commercial use, chemical purity, residual solvents, heavy metals, and enantiomeric purity are scrutinized.

European and North American markets typically require suppliers to hold EMA or FDA-approved manufacturing sites. Chinese and Indian suppliers can meet these standards if they possess appropriate certifications and quality systems, which should be verified through audits or third-party assessments.

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Market Trends and Emerging Suppliers

Given the niche nature of Macimorelin acetate, most suppliers are small-to-medium enterprises specializing in pharmaceutical intermediates. As demand grows, larger contract manufacturers and CROs are expanding their capabilities, emphasizing integrated supply chains, and regulatory support.

Emerging suppliers from Southeast Asia and emerging markets are increasingly gaining acceptance following validation of their quality systems. This diversification helps mitigate supply risks and foster competitive pricing.

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Conclusion

Securing a reliable bulk source of Macimorelin acetate requires rigorous vetting of suppliers based on quality, compliance, capacity, and cost. Chinese and Indian manufacturers serve as primary sources for high-volume, cost-sensitive needs, whereas European and North American companies provide higher assurances of regulatory compliance suited for clinical trials and commercial production.

Given the critical role of quality in diagnostic agents for AGHD, collaborations with suppliers holding GMP certification and proven track records are recommended. Engaging with reputable brokers or through established industry networks can facilitate access to qualified manufacturers.

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Key Takeaways

• The primary bulk API sources for Macimorelin acetate are manufacturers in China and India, with European and North American providers focusing on regulatory compliance.
• Suppliers must hold current GMP approvals, provide detailed analytical data, and demonstrate consistent manufacturing capacity.
• Due diligence—including audits and review of certificates—is crucial for ensuring product quality and regulatory acceptance.
• The market is evolving, with emerging suppliers offering new opportunities; diversification mitigates supply chain risks.
• Engaging experienced API brokers or contracting with established CMOs ensures reliable sourcing aligned with clinical and commercial needs.

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FAQs

1. What are the main factors influencing the choice of API suppliers for Macimorelin acetate?
Product quality, regulatory compliance, manufacturing capacity, cost, and delivery reliability are key factors influencing sourcing decisions for Macimorelin acetate API.

2. Are Chinese and Indian API manufacturers compliant with international regulatory standards?
Many Chinese and Indian manufacturers have obtained certifications such as GMP, ISO, USFDA, and EMA approvals. However, due diligence and audits are necessary before engagement, especially for regulated markets.

3. How can companies verify API quality from a supplier?
Request comprehensive Certificates of Analysis, batch records, stability data, and conduct audits or third-party evaluations to verify compliance with quality standards.

4. Is Macimorelin acetate API suitable for commercial pharmaceutical production?
Yes, if sourced from suppliers holding GMP certifications and with validated analytical methods ensuring purity and consistency, Macimorelin acetate API is suitable for commercial use.

5. What are emerging trends in the API supply chain for niche pharmaceuticals like Macimorelin acetate?
Increased use of contract manufacturing, regional diversification, quality assurance enhancements, and integrated supply chains are shaping the evolving landscape for niche APIs.

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References

[1] U.S. Food and Drug Administration. (2018). Macimorelin (Macrilen®) for adult growth hormone deficiency. FDA Label.
[2] PharmSource. (2022). API Market Insights.
[3] European Medicines Agency. (2021). Guidelines on Good Manufacturing Practice.
[4] China Food and Drug Administration. (2022). Certification and GMP Standards.
[5] Indian Drug Regulator. (2021). GMP Certification Process.