Bulk Pharmaceutical API Sources for ESTRONE

Bulk Pharmaceutical API Sources for ESTRONE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		E9750_SIGMA
Sigma-Aldrich		E1274_SIGMA
Vitas-M Laboratory		STK801833

Bulk Active Pharmaceutical Ingredient (API) Sources for: Estrone

Last updated: July 27, 2025

Overview of Estrone as an API

Estrone (E1) is a naturally occurring estrogen used widely in hormone replacement therapy (HRT), contraceptives, and as a research chemical. Precise sourcing of bulk estrone API is essential for pharmaceutical manufacturers aiming for product quality, regulatory compliance, and cost efficiency. Given its regulatory classifications, sourcing reliable suppliers with compliance to Good Manufacturing Practices (GMP) is paramount.

Global Market for Estrone API

The market for estrone API remains concentrated among a handful of manufacturers primarily based in China, India, and select European facilities. These regions dominate the supply chain due to cost advantages and technological capabilities. The primary considerations for sourcing include chemical purity, supply stability, regulatory approval, and adherence to global standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and internal GMP certifications.

Key Suppliers of Estrone API

1. Chinese Manufacturers

China remains the principal producer of estrone API, accounting for a significant portion of global supply. Major Chinese API producers offer competitive pricing, high-volume manufacturing capacity, and extensive export networks.

• Weifang Sunflower Pharmaceutical Co., Ltd.
  Offers estrone API in high purity (>99%) suitable for pharmaceutical formulations. The company maintains GMP certification and provides detailed COAs (Certificates of Analysis).

• Shandong Xinhua Pharmaceutical Co., Ltd.
  This firm supplies estrone with verified compliance to international standards and consistent quality. Their production facilities are certified according to ISO standards, and they serve global clients.

• Dongying City Lianhang Pharmaceutical Co., Ltd.
  Known for bulk API production, including estrone, with emphasis on quality assurance and scalable supply contracts.

2. Indian Manufacturers

India's pharmaceutical industry continues to strengthen its position as a supplier of hormonal APIs including estrone, due to cost advantages and robust quality standards.

• Gufic Biosciences Ltd.
  Offers estrone APIs with GMP certification, focusing on R&D collaborations for enzyme synthesis and chemical manufacturing.

• Synthelabo (India) Pvt. Ltd.
  Supplies estrone with documented compliance to pharmacopeial standards and extensive export experience.

• Bharat Biotech
  Known for high-quality hormonal APIs, including estrone, with a focus on innovation and strict quality control.

3. European and US Suppliers

While the bulk supply predominantly resides in Asia, a few European and US-based API manufacturers specialize in high-purity estrone APIs for niche markets, often with a focus on regulatory compliance.

• BASF (Germany)
  Globally recognized for biosciences and chemical manufacturing, BASF offers high-purity estrone for research and pharmaceutical manufacturing, adhering strictly to regulatory standards.

• Sigma-Aldrich (Part of Merck KGaA, USA/Germany)
  Offers estrone for research purposes, with a focus on purity and consistency. They also serve pharmaceutical clients with custom synthesis capabilities.

• Tocris Bioscience (UK)
  Supplies research-grade estrone, primarily for laboratory applications but with potential for pharmaceutical-grade procurement upon request.

Considerations for Sourcing Estrone API

• Purity and Certification:
  Pharmaceutical-grade APIs require purity exceeding 99%, with comprehensive COAs and batch records.

• Regulatory Compliance:
  Suppliers should have GMP certifications and documentation aligning with FDA, EMA, or other relevant authorities.

• Supply Stability:
  Evaluate supplier capacity and history of on-time delivery, especially critical during epidemic or supply chain disruptions.

• Pricing and MOQ:
  Cost varies significantly between regions. Suppliers in China and India often provide competitive rates for large orders, whereas European and US suppliers may cater to specialty or high-purity needs with higher costs.

• Intellectual Property (IP) and Licensing:
  Ensure suppliers hold proper licenses and do not infringe on patents, especially for complex synthesis methods.

Regulatory and Quality Assurance

All sources must adhere to stringent quality controls, including ISO certification, GMP compliance, and adherence to pharmacopeial standards. Buyers should perform due diligence such as third-party audits, sample testing, and validation of supplier certifications. Contracts should specify quality parameters, storage conditions, and delivery timelines.

Emerging Trends in API Sourcing for Estrone

• Shift towards sustainable and green synthesis methods to reduce environmental impact and minimize impurities.
• Increased vertical integration by large pharmaceutical companies seeking supply chain independence.
• Use of advanced analytical techniques (e.g., HPLC, NMR, MS) for verifying API quality at procurement.

Conclusion

The global landscape for sourcing estrone API is characterized by a dominant Asian manufacturing presence, with European and US suppliers focusing on specialty and high-purity needs. Pharmaceutical companies should prioritize compliance and quality assurance over cost to ensure regulatory approval and consistent product performance. Strategic partnerships with reputable suppliers and rigorous qualification processes are essential to mitigate supply chain risks.

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Key Takeaways

• Asian suppliers, particularly Chinese and Indian manufacturers, dominate estrone API supply due to cost-effectiveness and capacity.
• Strict compliance with GMP, ISO, and pharmacopeial standards is critical for pharmaceutical-grade APIs.
• European and US suppliers provide high-purity estrone APIs optimized for regulatory procedures and niche markets.
• Due diligence, quality verification, and supply chain stability are pivotal in procurement decisions.
• Emerging sustainable manufacturing practices are influencing future sourcing strategies for estrone API.

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FAQs

1. What should I consider when selecting a supplier for estrone API?
Prioritize GMP certification, consistent quality, regulatory compliance, supply capacity, and cost. Conduct audits and verify certifications to mitigate risks.

2. Is there a difference between research-grade and pharmaceutical-grade estrone API?
Yes, research-grade APIs typically have lower purity and less extensive quality documentation, whereas pharmaceutical-grade APIs meet stringent purity and compliance standards (e.g., >99%, GMP-certified).

3. Are there regulatory restrictions on importing estrone API?
Yes, as a controlled substance in certain jurisdictions, estrone importation is subject to strict regulatory controls under DEA, FDA, and equivalent authorities. Ensure proper licensing and documentation.

4. How has the COVID-19 pandemic affected estrone API supply chains?
Supply chains faced disruptions due to factory shutdowns, logistical bottlenecks, and raw material shortages. Diversifying suppliers and maintaining buffer inventories are advisable strategies.

5. What are the environmental considerations in sourcing estrone API?
Green synthesis methods reduce environmental impact. Buyers should inquire about the supplier’s environmental management systems and adherence to sustainable manufacturing practices.

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Sources:

[1] Global Industry Analysts. Hormone API Market Forecast. 2022.
[2] US Food and Drug Administration. GMP Guidelines for APIs. 2021.
[3] European Pharmacopoeia. Monograph on Estrone. 2020.
[4] IQVIA. Pharmaceutical API Supply Chain Overview. 2022.
[5] McKinsey & Company. Trends in Pharmaceutical Sourcing. 2023.