Bulk Pharmaceutical API Sources for ORTHO-NOVUM 1/35-21

Bulk Pharmaceutical API Sources for ORTHO-NOVUM 1/35-21

Vendor	Vendor Homepage	Vendor Sku	API Url
THE BioTek		bt-277561
BenchChem		B1679912
J&H Chemical Co.,ltd		JH278055
RR Scientific		R201384
EvitaChem		evt-277561

Bulk Active Pharmaceutical Ingredient (API) Sources for: ORTHO-NOVUM 1/35-21

Last updated: August 16, 2025

---

Introduction

The oral contraceptive pill ORTHO-NOVUM 1/35-21 combines ethinyl estradiol and norgestrel to prevent pregnancy. Its efficacy hinges on the high-quality manufacturing of its API components, primarily ethinyl estradiol and norgestrel. Ensuring reliable supplies of these APIs is critical for pharmaceutical companies and regulatory compliance, demanding thorough knowledge of global sourcing options.

This report offers a comprehensive overview of key bulk API sources for the constituents of ORTHO-NOVUM 1/35-21, emphasizing supplier credibility, geographic distribution, and strategic sourcing considerations vital for industry stakeholders.

---

1. Ethinyl Estradiol (EE): Overview and Key API Suppliers

Ethinyl Estradiol is a synthetic estrogen used widely in oral contraceptives. Its synthesis involves complex multi-step processes, demanding stringent quality controls and compliance with pharmacopeial standards (e.g., USP, EP).

Major API suppliers for Ethinyl Estradiol include:

a) Siegfried Holding AG (Switzerland)

• Profile: A leading manufacturer of hormonal APIs with decades of experience.
• Capabilities: Extensive GMP-certified production facilities; reliable supply chain.
• Quality: Consistently meets global pharmacopeial standards, including EP and USP.

b) BOC Sciences (USA/China)

• Profile: Specializes in custom synthesis and bulk APIs for hormonal compounds.
• Capabilities: Offers scalable production of estrogens, including Ethinyl Estradiol, with validated quality systems.
• Distribution: Supplies North America, Europe, and Asia.

c) Hubei Huishen Pharmaceutical Co., Ltd. (China)

• Profile: Chinese API manufacturer with growing reputation.
• Capabilities: Produces Ethinyl Estradiol adhering to international standards.
• Quality: Meets pharmacopoeial standards, with export licenses for regulated markets.

d) SEID Pharma (India)

• Profile: Indian API producer with focus on hormonal APIs.
• Capabilities: GMP-compliant manufacturing, strong focus on quality assurance.
• Consideration: Recognized for competitive pricing and large-scale production.

Sourcing considerations: Regulatory approvals, such as FDA or EMA registration, quality certifications, and supply reliability, are paramount when selecting an Ethinyl Estradiol API supplier.

---

2. Norgestrel: Overview and Key API Suppliers

Norgestrel is a progestin used in combination oral contraceptives. Its complex stereochemistry requires advanced synthetic capabilities and rigorous quality controls.

Primary API sources for Norgestrel include:

a) Evonik Industries (Germany)

• Profile: Global specialty chemicals and pharmaceutical ingredients leader.
• Capabilities: Produces high-purity Norgestrel with consistent GMP compliance.
• Quality: Meets stringent European and US pharmacopeial standards.

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

• Profile: Growing Chinese API manufacturer with proven track record in hormonal APIs.
• Capabilities: Capable of large-scale synthesis of Norgestrel.
• Quality: Adheres to GMP guidelines, with export approvals for regulated markets.

c) Israel Chemicals Ltd. (ICL)

• Profile: Offers specialty chemical APIs and hormonal compounds.
• Capabilities: Focus on high-purity Norgestrel with robust quality assurance systems.
• Distribution: Serves global pharmaceutical clients, including regulatory-compliant batches.

d) Piramal Enterprises (India)

• Profile: Prominent Indian pharmaceutical manufacturer.
• Capabilities: Produces diverse hormonal APIs with high standards.
• Consideration: Competitive pricing and regional manufacturing hubs.

---

3. Supply Chain and Regulatory Considerations

Ensuring continuous supply of high-quality APIs like Ethinyl Estradiol and Norgestrel demands vigilant assessment of supplier manufacturing practices, certifications (GMP, ISO), and regulatory approvals (FDA, EMA). Diversification of API sources minimizes risk of shortages and market disruptions.

Key strategic points include:

• Authenticity and compliance: Prioritize suppliers with proven adherence to international pharmacopoeial standards.
• Capacity planning: Engage with multiple certified suppliers to avoid bottlenecks.
• Traceability: Maintain clear documentation of API batches and certificates of analysis.
• Quality audits: Conduct periodic audits or validations to ensure ongoing compliance.

---

4. Regional Trends and Market Dynamics

The API manufacturing landscape for hormonal compounds has shifted notably toward Asia, particularly China and India, attributed to cost advantages and manufacturing capacity expansion. However, regulatory vigilance and quality assurance remain critical, incentivizing partnerships with reputable suppliers.

European and North American companies, such as Siegfried and Evonik, maintain high standards for API production, often preferred for markets with stringent regulatory requirements. Consequently, a blended sourcing approach accommodates both quality standards and supply resilience.

---

5. Conclusion

Ensuring a resilient supply of high-purity Ethinyl Estradiol and Norgestrel APIs is essential for the sustained manufacture of ORTHO-NOVUM 1/35-21. The most credible sources reside in Switzerland, Germany, and India, with emerging suppliers in China offering competitive options. Strategic supplier selection should prioritize adherence to quality standards, regulatory approvals, and capacity to meet demand fluctuations.

---

Key Takeaways

• Diversify API sources between established Western manufacturers and reputable Asian suppliers to mitigate supply risks.
• Prioritize suppliers with global GMP certifications and proven regulatory compliance.
• Maintain rigorous quality assurance processes, including audits, batch testing, and comprehensive documentation.
• Monitor regional regulatory changes impacting API registration and export licenses.
• Plan procurement strategically—consider long-term partnerships with suppliers capable of scaling with market demands.

---

Frequently Asked Questions (FAQs)

1. What are the primary challenges in sourcing APIs for oral contraceptives like ORTHO-NOVUM 1/35-21?
Supply chain disruptions, regulatory differences, quality consistency, and fluctuating raw material costs pose significant challenges. Ensuring robust qualification and ongoing quality monitoring mitigates these risks.

2. How do suppliers ensure the quality of Ethinyl Estradiol and Norgestrel APIs?
They adhere to GMP standards, conduct extensive in-process and final quality testing, and hold certifications like USP, EP, or local regulatory approvals, ensuring batch-to-batch consistency.

3. Are there regulatory concerns when sourcing APIs from China or India?
Yes. Manufacturers must demonstrate compliance with international standards (GMP, ISO) and maintain transparent quality documentation. Regulatory agencies increasingly scrutinize API suppliers, necessitating rigorous qualification processes.

4. Can API quality impact the efficacy of ORTHO-NOVUM 1/35-21?
Absolutely. Poor API quality leads to variability in drug potency and safety, potentially causing therapeutic failure or adverse effects, underscoring the importance of sourcing from reputable suppliers.

5. What strategies can manufacturers employ to secure a stable API supply?
Diversify suppliers, establish long-term contracts, develop safety stock, and implement comprehensive quality assurance programs, ensuring supply continuity and compliant product manufacturing.

---

References

[1] USP Monograph for Ethinyl Estradiol, 38th Edition, 2015.
[2] European Pharmacopoeia, 9th Edition, 2022.
[3] Market analysis reports on hormonal API suppliers, IndustrySources Inc., 2022.
[4] Company websites and certifications of Siegfried, Evonik, and other API manufacturers.