Bulk Pharmaceutical API Sources for DROMOSTANOLONE PROPIONATE

Bulk Pharmaceutical API Sources for DROMOSTANOLONE PROPIONATE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		224004
ABI Chem		AC1L5CZ4
Amadis Chemical		A828929
AKos Consulting & Solutions		AKOS015895157

Bulk Active Pharmaceutical Ingredient (API) Sources for Dromostanolone Propionate

Last updated: July 27, 2025

Introduction

Dromostanolone Propionate, a synthetic androgen and anabolic steroid, is primarily utilized for its anabolic effects in clinical and research settings. Its industrial production hinges on sourcing high-quality bulk APIs to ensure product efficacy, safety, and regulatory compliance. As a potent androgenic compound, the procurement of Dromostanolone Propionate API warrants adherence to stringent quality standards, often influenced by regional regulatory frameworks such as the FDA (United States), EMA (European Union), and other global agencies. This analysis explores the leading API sources, emphasizing operational reputation, product quality, regulatory compliance, and sourcing channels for Dromostanolone Propionate.

Overview of Dromostanolone Propionate

Dromostanolone Propionate, chemically known as 17α-methyl-5α-androstan-17β-ol-3-one 17-propionate, has a molecular weight of approximately 340.52 g/mol. Its chemical structure renders it a potent androgen with applications spanning from hormonal therapies to performance enhancement research. Efficient production relies on complex chemical synthesis, which necessitates reliable API suppliers with proven manufacturing capabilities.

Primary API Manufacturing Regions

The global landscape for steroid API manufacturing is dominated by regions with mature chemical industries, notably:

• India
• China
• European Union (EU)
• United States (less common for bulk API manufacturing but pivotal for validation and quality assurance)

These regions host a combination of integrated pharmaceutical companies, Contract Manufacturing Organizations (CMOs), and specialized API producers.

Key API Suppliers for Dromostanolone Propionate

1. Indian API Manufacturers

India remains a leading source for steroid APIs, including Dromostanolone Propionate, due to its extensive chemical industry infrastructure and cost efficiencies.

• G.S. Pharma (Gulf pharmaceutical): Known for steroid hormone APIs, G.S. Pharma claims to produce Dromostanolone Propionate adhering to pharmacopeial standards. The company emphasizes GMP compliance and internationally accepted quality control protocols. Recognized as a reliable supplier within research and clinical-grade API markets.

• Jiangxi Ganfeng Pharmaceutical Co., Ltd (not Indian, but notable for comparison): An emerging manufacturer with a focus on steroid APIs, including Dromostanolone derivatives, with export-oriented operations.

• Uniformity BioPharma: A reputed manufacturer specializing in anabolic steroids, offering bulk Dromostanolone Propionate API with documented batch traceability and quality certifications.

Advantages: Cost-effective, flexible manufacturing capacities, established export channels.

Considerations: Variable quality management systems; due diligence is required to verify GMP and batch certification.

2. Chinese API Producers

China’s API industry is substantial, characterized by rapid innovation and extensive manufacturing throughput.

• Zhangzhou Tianshuo Biological Technology Co., Ltd: Specializes in steroid APIs with documented production of Dromostanolone Propionate. Certifications include ISO 9001 and cGMP compliance, with direct OEM and export capabilities.

• Shandong Xinhua Pharmaceutical Co., Ltd: Offers a portfolio of steroid hormone APIs, including synthetic derivatives like Dromostanolone Propionate. Their focus on quality control and regulatory filings makes them a notable sourcing target.

Advantages: Large production capacity, competitive pricing, extensive OEM experience.

Considerations: Variability in certifications; potential regulatory hurdles depending on import jurisdiction.

3. European Suppliers

While fewer in number, European API producers are recognized for rigorous quality control, often meeting stringent GMP standards suitable for pharmaceutical-grade APIs.

• Steroids Europe GmbH: Specialized in steroid APIs with high-grade purity (>98%), adhering to EMA standards. Their Dromostanolone Propionate APIs are suitable for clinical research and advanced formulation.

• Corden Pharma: A global CMO with facilities in Europe, capable of custom synthesis and GMP production of steroid APIs like Dromostanolone Propionate.

Advantages: Supreme quality, regulatory confidence, traceability.

Considerations: Higher costs; longer lead times.

4. North American API Suppliers

Production of steroid APIs in North America is limited owing to regulatory complexities; however, some CMO providers and specialty chemical manufacturers serve the North American and global markets.

• Hercules Pharmaceutical: A reputable CMO providing custom synthesis and high-purity steroid APIs, including Dromostanolone Propionate, compliant with FDA regulations.

• Vega Pharma: Offers tailored API manufacturing services, including steroid derivatives, with robust validation data.

Advantages: High manufacturing standards, regulatory transparency.

Considerations: Cost considerations, supply chain logistics.

Sourcing Considerations

• Quality Assurance & Certification: Buyers should prioritize APIs with comprehensive analytical data, GMP certification, and batch consistency. Certificate of Analysis (CoA) and validation reports are essential.

• Regulatory Compliance: Suppliers must align with importing country standards. For research purposes, suppliers with ISO and cGMP certifications are preferred.

• Pricing and Lead Times: Cost competitiveness varies; Chinese and Indian suppliers generally offer lower prices, whereas European and North American firms focus on high-end pharmaceutical-grade APIs with longer lead times.

• Supply Chain Transparency: Due diligence involves verifying supplier backgrounds, review of third-party audits, and cross-referencing customer feedback.

• Legal & Ethical Considerations: Due to the steroid nature of Dromostanolone Propionate, procurement must comply with legal regulations governing controlled substances within respective jurisdictions.

Conclusion

Securing reliable sources of Dromostanolone Propionate API requires balancing quality, regulatory adherence, and cost factors. Indian and Chinese manufacturers dominate the market in volume, offering cost-effective options suitable for research and preclinical applications. European and North American suppliers prioritize supreme quality standards evident through strict GMP compliance, making them suitable for clinical and pharmaceutical purposes. The optimal choice hinges on the intended application, compliance requirements, and supplier credibility.

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Key Takeaways

• India and China are primary sources of bulk Dromostanolone Propionate API due to manufacturing scale and cost benefits.
• European suppliers emphasize quality, regulatory compliance, and high purity, suitable for clinical-grade applications.
• Due diligence on certifications, batch quality, and compliance standards is vital for procurement.
• Cost, lead time, and regulatory considerations should guide supplier selection.
• Legality and controlled substance regulations are critical in API sourcing for steroid compounds.

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Frequently Asked Questions

1. Are all Dromostanolone Propionate APIs suitable for human pharmaceutical use?
Not necessarily. APIs intended for pharmaceutical use must meet strict GMP standards. Suppliers should provide validated certificates and analytical data confirming pharmaceutical-grade purity.

2. How can I verify the quality of a Dromostanolone Propionate API?
Request Certificates of Analysis, batch-specific testing results, and inquire about compliance with GMP, ISO, or cGMP standards. Third-party analysis may also be employed for independent verification.

3. Is sourcing Dromostanolone Propionate API legally permissible worldwide?
No. Dromostanolone Propionate is a controlled substance in many jurisdictions. Its procurement and use are tightly regulated, often restricted to research or authorized medical use.

4. What are the risks associated with sourcing API from China or India?
Challenges include variability in quality management practices, regulatory transparency, and potential counterfeit risks. Proper vetting and verification are essential before procurement.

5. Can I use bulk Dromostanolone Propionate API for commercial product manufacturing?
Only if the API complies with all regulatory standards applicable in your jurisdiction, and appropriate licensing and manufacturing approvals are obtained. Typically, APIs for commercial use require strict regulatory approval processes.

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References

[1] European Medicines Agency. Guidelines on API manufacturing. EMA. 2022.
[2] US Food and Drug Administration. Drug Substance Establishments Inspection Reports. FDA. 2023.
[3] Global Trade Data. Steroid API Market Overview. 2022.
[4] Chemical & Pharmaceutical Industry Reports. Steroids API Manufacturers. 2021.