Bulk Pharmaceutical API Sources for DEMULEN 1/50-28

Bulk Pharmaceutical API Sources for DEMULEN 1/50-28

Vendor	Vendor Homepage	Vendor Sku	API Url
BenchChem		B1198126
THE BioTek		bt-1539018
RR Scientific		R4630915

Bulk Active Pharmaceutical Ingredient (API) Sources for: DEMULEN 1/50-28

Last updated: August 16, 2025

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Introduction

Demulen 1/50-28, a combined oral contraceptive formulated with Ethinyl Estradiol 0.05 mg and Levonorgestrel 0.15 mg, necessitates sourcing high-quality Active Pharmaceutical Ingredients (APIs) to ensure efficacy, safety, and regulatory compliance. Accurate identification of reliable API suppliers is critical for pharmaceutical manufacturers aiming to produce Demulen 1/50-28, especially considering stringent quality standards and patent regulations.

This comprehensive analysis evaluates viable bulk API sources for Ethinyl Estradiol and Levonorgestrel, emphasizing supplier credibility, GMP compliance, market presence, and supply chain stability.

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1. API Specifications for Demulen 1/50-28

• Ethinyl Estradiol (EE): A synthetic estrogen, purity ≥ 99%, with appropriate impurity profiles and certificates of analysis (CoA).
• Levonorgestrel (LNG): A progestin, purity ≥ 99%, meeting pharmacopoeial standards with validated analytical methods.

Both APIs require strict adherence to compendial standards such as USP, EP, or JP, depending on target markets.

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2. Leading API Suppliers for Ethinyl Estradiol

a. Teva Pharmaceutical Industries Ltd.

• Overview: A global leader in API manufacturing, Teva supplies Ethinyl Estradiol for numerous generic and branded formulations.
• GMP Compliance: Certified under various regulatory authorities including FDA, EMA, and PMDA.
• Supply Capabilities: Large-scale production with robust quality control measures.
• Market Access: Established presence across North America, Europe, and Asia.
• Certifications: ISO 9001, ISO 14001, and active certifications in cGMP.

b. Synthesis and Custom Synthesis Providers (e.g., Jiangsu Hengrui Medicine Co., Ltd.)

• Overview: Chinese manufacturers with growing global footprints.
• GMP and Regulatory Status: Increasingly compliant with international standards; often provide coA, stability data, and validation protocols.
• Key Advantages: Competitive pricing and flexible supply arrangements.

c. Mylan (now part of Viatris)

• Overview: Major API manufacturer with a focus on oral contraceptive APIs.
• Quality Assurance: Extensive documentation, batch records, and validated manufacturing processes.
• Supply Security: Long-standing supply contracts and diverse manufacturing sites.

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3. Leading API Suppliers for Levonorgestrel

a. Gedeon Richter Plc.

• Overview: Recognized producer of hormonal APIs, including Levonorgestrel.
• Regulatory Compliance: Holds certifications from major regulatory bodies.
• Volume Capability: Large-scale capacity with dedicated facilities for hormonal APIs.
• Supply Reliability: Long-standing track record of consistent supply.

b. Piramal Healthcare

• Overview: Indian pharmaceutical company with a significant portfolio of hormonal APIs.
• Compliance: US FDA, EMA, and other authorities approved manufacturing sites.
• Product Quality: Validated analytical techniques and stability testing.

c. Watson Pharmaceuticals

• Overview: Supplies Levonorgestrel APIs to global markets with competitive pricing.
• Quality Standards: Adherence to cGMP, robust documentation, and quality control.

d. Samsung BioLogics

• Overview: Newer entrant with advanced API manufacturing capabilities.
• Specialization: Offers high-purity hormonal APIs with scalable production.

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4. Criteria for Selecting API Sources

When sourcing APIs for Demulen 1/50-28, procurement teams must prioritize:

• Regulatory Approvals: Suppliers with validated GMP compliance and drug master files (DMF) submissions.
• Quality Control: Certificates of analysis, stability data, impurity profiles, and risk assessments.
• Manufacturing Capacity: Ability to meet demand forecasts and flexible supply timelines.
• Cost and Logistics: Competitive pricing without compromising quality, along with reliable shipping and customs clearance.
• Traceability and Documentation: Full batch traceability, transparent supply chain logs, and audit readiness.

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5. Supply Chain Considerations

Given geopolitical complexities—such as trade restrictions or pandemic-related disruptions—multi-source sourcing becomes essential. Diversifying supplier portfolios across regions (Europe, India, China, North America) mitigates risk.

Additionally, maintaining vendor approval protocols, regular audits, and monitoring of supply stability are crucial for uninterrupted production of Demulen 1/50-28.

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6. Emerging Trends and Future Outlook

• Innovation in API Manufacturing: Increased investment in sustainable, cost-effective synthesis pathways to reduce environmental impact.
• Regulatory Stringency: Suppliers investing in advanced analytics and validation to meet evolving quality standards.
• Supply Chain Resilience: Emphasizing regional manufacturing hubs to decrease latency and dependency on single regions.
• Digitalization: Use of blockchain for enhanced traceability and quality assurance.

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Conclusion

Optimized sourcing of Ethinyl Estradiol and Levonorgestrel APIs forms the backbone of high-quality Demulen 1/50-28 production. Reputable suppliers such as Teva, Gedeon Richter, Piramal, and Viatris offer dependable options aligned with global regulatory demands. Ensuring supplier validation, quality assurance, and supply chain resilience is imperative for pharmaceutical manufacturers seeking operational excellence.

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Key Takeaways

• Focus on GMP-certified API suppliers with proven regulatory compliance.
• Diversify sourcing across regions to mitigate supply chain risks.
• Prioritize suppliers with robust documentation and analytical validation.
• Maintain active vendor qualification programs and ongoing audits.
• Leverage technological advancements to enhance traceability and quality assurance.

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FAQs

Q1: What are the primary regulatory standards to consider when sourcing APIs for Demulen 1/50-28?
A1: Key standards include USP, EP, JP, and ICH guidelines. Ensure suppliers possess necessary certifications (e.g., FDA approval, EMA certification) and quality documentation compliant with these standards.

Q2: How can manufacturers verify API quality from suppliers?
A2: Verification includes reviewing Certificates of Analysis, batch records, stability data, impurity profiles, and conducting audits or third-party inspections.

Q3: Are Chinese or Indian API manufacturers reliable sources for Ethinyl Estradiol and Levonorgestrel?
A3: Yes, many Chinese and Indian manufacturers have achieved WHO-GMP certification and meet international regulatory standards. However, due diligence and validation are essential.

Q4: What are the risks of relying on a single API supplier?
A4: Dependency increases vulnerability to supply disruptions, quality issues, and regulatory changes. Diversification minimizes these risks.

Q5: How does supply chain resilience impact the production of Demulen 1/50-28?
A5: A resilient supply chain ensures consistent API availability, reducing delays, compliance risks, and financial losses associated with manufacturing downtime.

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Sources

1. [1] U.S. Pharmacopeia (USP). “API Requirement Standards.”
2. [2] European Pharmacopoeia (EP). “Guidelines for API validation.”
3. [3] Global API Market Reports, 2023.
4. [4] FDA and EMA API manufacturing guidelines.
5. [5] Industry reports on API supply chain dynamics, 2022.