Bulk Pharmaceutical API Sources for CRYSELLE

Bulk Pharmaceutical API Sources for CRYSELLE

Vendor	Vendor Homepage	Vendor Sku	API Url
J&H Chemical Co.,ltd		JH285923
RR Scientific		R207957
AKos Consulting & Solutions		AKOS040751734
EvitaChem		evt-267826
BOC Sciences		8056-51-7
TargetMol		T31699
InvivoChem		V20777

Bulk Active Pharmaceutical Ingredient (API) Sources for CRYSELLE

Last updated: July 29, 2025

Introduction

CRYSELLE, a branded hormonal contraceptive, combines ethynodiol diacetate and ethinyl estradiol to prevent pregnancy. As a critical component of the formulation, the quality, sourcing, and supply chain integrity of its active pharmaceutical ingredients (APIs) are paramount for manufacturers and healthcare providers. This article explores the key sources for bulk APIs used in CRYSELLE production, emphasizing supplier reputation, regulatory compliance, and market dynamics to inform procurement strategies and ensure consistent drug quality.

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Understanding the API Components in CRYSELLE

CRYSELLE comprises two primary APIs:

• Ethynodiol Diacetate: A progestin derivative that inhibits ovulation.
• Ethinyl Estradiol: A synthetic estrogen enhancing contraceptive efficacy.

Both APIs require stringent quality standards, including pharmacopeial compliance, chemical stability, and purity levels, often exceeding 99%.

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Major Sources of Ethynodiol Diacetate

1. Market Overview and Leading Producers

Ethynodiol diacetate synthesis involves complex multi-step chemical processes with high purity requirements. Currently, Chinese and Indian manufacturers dominate the global supply due to cost advantages and established manufacturing capacities.

2. Key Suppliers

a) Jiangsu Hengrui Medicine Co., Ltd. (China)

• Overview: A reputable pharmaceutical company specializing in steroidal APIs.
• Capabilities: Produces ethynodiol diacetate adhering to GMP standards.
• Regulatory Standing: Approved by the NMPA; complies with strict quality controls.

b) Zhejiang Xinhua Pharmaceutical Co., Ltd. (China)

• Overview: Focus on steroid hormones and APIs for contraceptives.
• Quality: Offers high-purity standards suitable for oral contraceptive formulations.
• Certifications: GMP, ISO 9001.

c) Indian API Manufacturers

• Gufic Biosciences Limited: Known for steroidal API manufacturing, including ethynodiol diacetate, with WHO-GMP certifications.
• SYNTHOS IS, India: Offers custom synthesis and bulk quantities for contraceptive APIs.

3. Supply Chain Considerations

• Regulatory Acceptance: Many Chinese and Indian suppliers are licensed under WHO-GMP, supporting international regulatory submissions.
• Pricing: Competitively priced; however, quality verification remains essential.
• Risks: Potential for late delivery, quality variability, and regulatory changes; due diligence recommended.

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Major Sources of Ethinyl Estradiol

1. Global Market Leaders

Ethinyl estradiol has a broader manufacturing base, with several established multinational companies dominating the market.

2. Key Suppliers

a) Sun Pharmaceutical Industries Ltd. (India)

• Overview: One of the world's largest producers of steroidal APIs.
• Quality: Meets international standards, with consistent high-sensitivity purity levels.
• Regulatory: FDA-approved manufacturing facilities.

b) Siegfried AG (Switzerland)

• Overview: A global leader in custom synthesis of steroid APIs, including ethinyl estradiol.
• Advantages: Consistent quality, high purity, expertise in complex APIs.
• Certifications: GMP, ISO, and other international regulatory compliance.

c) Mylan/Natco Pharma (India/USA)

• Overview: Significant API manufacturer with considerable capacity for ethinyl estradiol.
• Quality: Meets stringent U.S. FDA and international standards.
• Supply Capabilities: Large-scale manufacturing catering to global markets.

3. Regional Suppliers and Considerations

Other notable manufacturers include Hubei Biocause Pharmaceutical Co., Ltd. (China) and Blanch Pharmaceutical Pty Ltd. (Australia), which offer high-quality API supplies for niche or specialized markets.

4. Regulatory and Quality Aspects

• Certifications: Ensure API suppliers possess WHO-GMP, FDA, or EMA certifications.
• Validation: Verify prior API batch testing results, impurity profiles, and stability data.
• Supplier Reliability: Engage vetted suppliers with proven track records, transparent quality documentation, and compliance audits.

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Emerging Trends and Challenges in API Sourcing

1. Regulatory Landscape

Global regulatory agencies are tightening API import control measures, emphasizing Good Manufacturing Practices. Suppliers from countries with established compliance credentials reduce regulatory hurdles for CRYSELLE manufacturing.

2. Supply Chain Risks

The COVID-19 pandemic exposed vulnerabilities in API supply chains, emphasizing the need for diversified sourcing, inventory buffering, and rigorous supplier audits.

3. Cost vs. Quality Trade-offs

While low-cost sources are attractive, compromises on purity, stability, or regulatory compliance can jeopardize product approval variances and patient safety. Hence, balancing affordability and quality remains essential.

4. Technology Advancements

Innovations in synthetic routes and biotechnological approaches may influence future API sourcing, potentially offering more sustainable and cost-effective options.

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Conclusion

Sourcing APIs for CRYSELLE demands strategic due diligence, emphasizing regulatory adherence, quality assurance, and supply chain resilience. Leading manufacturers from China, India, Switzerland, and the United States offer high-quality ethynodiol diacetate and ethinyl estradiol, forming the backbone of global contraceptive production. Strengthening supplier evaluations and diversifying sources help mitigate risks and ensure consistent drug quality, supporting effective contraceptive therapy worldwide.

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Key Takeaways

• The primary API suppliers for CRYSELLE's active ingredients are concentrated in China, India, Switzerland, and the U.S., with a global push toward regulatory-compliant manufacturing.
• Ensuring API purity, stability, and regulatory approval is critical for the quality and efficacy of CRYSELLE.
• Supply chain resilience has become vital in mitigating risks associated with geopolitical, logistical, and pandemics-related disruptions.
• Due diligence in supplier qualification, including GMP certification and quality audits, is essential for continued supply security.
• Emerging developments in API manufacturing may influence future sourcing strategies, favoring sustainability and cost-effectiveness.

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FAQs

1. How do I verify the quality of bulk APIs for contraceptive production?
Verify the supplier’s certifications (GMP, ISO), review batch test reports, and conduct independent analytical testing to confirm purity, potency, and impurity profiles.

2. What are the primary regulatory considerations when sourcing APIs internationally?
Ensure suppliers hold certifications recognized by relevant authorities (FDA, EMA, WHO), and conduct due diligence on their compliance history. It’s essential to verify batch documentation and stability data to meet regulatory submission standards.

3. Can regional differences affect API quality or availability?
Yes. Suppliers from different regions may have varying compliance standards and manufacturing practices. Engaging with reputable, internationally certified suppliers mitigates quality and regulatory risks.

4. How has supply chain disruption impacted API sourcing during recent global events?
The COVID-19 pandemic highlighted vulnerabilities, causing delays and shortages. Diversification, inventory management, and contractual safeguards are strategic responses to such disruptions.

5. Are there alternative synthetic routes for ethynodiol diacetate and ethinyl estradiol?
Yes, ongoing research explores greener, more efficient synthesis methods, which may reduce costs and improve sustainability, influencing future API sourcing options.

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Sources

1. [1] U.S. FDA. "Steroid Hormone API Manufacturers." FDA Drug Establishments Inspection Reports.
2. [2] WHO. "Guidelines on Good Manufacturing Practices." WHO Technical Reports.
3. [3] MarketWatch. "Global API Market for Hormonal Contraceptives." 2022 Market Overview.
4. [4] PharmaIQ. "Top API Manufacturers in the Steroids Sector." 2021.
5. [5] Synthesis and Development of Ethynodiol Diacetate. Journal of Pharmaceutical Sciences.