Bulk Pharmaceutical API Sources for ORTHO-NOVUM 10/11-28

Bulk Pharmaceutical API Sources for ORTHO-NOVUM 10/11-28

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 10/11-28

Last updated: August 12, 2025

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Introduction

Ortho-Novum 10/11-28 is a combined oral contraceptive pills (COCs) comprising ethinyl estradiol and norgestimate. As with all pharmaceutical products, ensuring a trusted, reliable source of high-quality API—specifically, ethinyl estradiol and norgestimate—is fundamental for manufacturing, regulatory compliance, and product efficacy. This article explores the current landscape of bulk API sources suitable for producing ORTHO-NOVUM 10/11-28, focusing on suppliers' capabilities, sourcing considerations, and quality standards.

API Components in ORTHO-NOVUM 10/11-28

1. Ethinyl Estradiol: A synthetic estrogen used for regulating the menstrual cycle and preventing ovulation.

2. Norgestimate: A progestin hormone that prevents pregnancy by inhibiting ovulation, altering cervical mucus, and affecting the endometrial lining.

The successful production of ORTHO-NOVUM 10/11-28 depends heavily on the consistent quality and supply of these APIs, necessitating leverage on global manufacturing hubs.

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Global API Manufacturing Landscape for ORTHO-NOVUM 10/11-28

1. Ethinyl Estradiol API Suppliers

Ethanol estradiol's synthesis is complex, demanding strict adherence to Good Manufacturing Practices (GMP) to assure potency, purity, and stability.

• Key Suppliers:

  • Novartis (Switzerland): Historically, a primary source for ethinyl estradiol APIs, leveraging in-house synthesis and stringent quality controls. Their APIs are compliant with major pharmacopeials, including USP, EP, and JP.

  • Jiangsu Hengrui Medicine Co., Ltd. (China): A significant producer with GMP-certified facilities; offers bulk ethinyl estradiol suitable for generics and branded products.

  • Teva Pharmaceutical Industries Ltd. (Israel): Known for API manufacturing, including steroid hormones, with a focus on high purity and supply stability.

  • Weiwei Chemical Co., Ltd. (China): Emerging supplier capable of providing competitive pricing and quality APIs.

  • Sichuan Guoda Pharmaceutical Co., Ltd. (China): A recognized manufacturer with ISO certification, supplying APIs to global markets.

2. Norgestimate API Suppliers

Norgestimate's synthesis is intricate, involving multiple stereoselective steps, making API quality crucial.

• Key Suppliers:

  • Lupin Limited (India): Provides high-quality norgestimate APIs produced under GMP conditions, compliant with international standards.

  • Watson Laboratories (USA): Offers reliable API supplies with extensive regulatory approvals, ensuring consistency.

  • Hikma Pharmaceuticals (UK): Manufactures norgestimate APIs satisfying stringent quality benchmarks.

  • Zhejiang NHU Co., Ltd. (China): Growing presence in hormone API space; offers competitive pricing with GMP certification.

  • Mitsubishi Tanabe Pharma Corporation (Japan): Premium supplier with high-quality standards, primarily serving regulated markets.

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Sources of API Quality and Regulatory Compliance

When selecting API sources for ORTHO-NOVUM 10/11-28, the following considerations are critical:

• GMP Certification: Ensures APIs meet safety, quality, and efficacy standards mandated by agencies like the FDA, EMA, and PMDA.

• Pharmacopoeial Compliance: APIs must conform to USP, EP, JP, or other relevant pharmacopeias' specifications.

• ISO Certification: Demonstrates adherence to internationally recognized quality management standards.

• Batch Certification & Stability Data: Confirming batch-to-batch consistency and long-term stability.

• Environmental and Ethical Standards: Suppliers adhering to responsible manufacturing practices mitigate supply chain risks.

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Sourcing Strategies for API Procurement

a. Direct Procurement from Manufacturers

Engaging directly with API manufacturers provides benefits of cost control, customized delivery schedules, and quality assurance. As such, multinational pharmaceutical companies often establish Long Term Agreements (LTAs) with proven suppliers.

b. Contract Manufacturing Organizations (CMOs)

Utilizing CMOs that source APIs from reputable manufacturers ensures supply flexibility, especially for large-scale production such as ORTHO-NOVUM 10/11-28.

c. API Brokers

Although brokers can offer diverse options, critical evaluation of their compliance, certifications, and supply history is essential to avoid counterfeit or substandard APIs.

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Emerging Trends and Challenges

• Supply Chain Diversification: To mitigate geopolitical and pandemic-related disruptions, sourcing from multiple regions—China, India, Europe—is advisable.

• API Storage & Stability: Proper handling and storage of APIs are essential to maintain efficacy over time.

• Regulatory Surveillance: Manufacturers must provide extensive documentation and undergo periodic audits to ensure transparency and compliance.

• Cost Considerations: Balancing price with quality remains a core challenge; cheaper APIs may jeopardize regulatory approval and efficacy.

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Conclusion

Securing reliable bulk API sources for ethinyl estradiol and norgestimate is central to manufacturing ORTHO-NOVUM 10/11-28. Major suppliers from China, India, Europe, and North America offer high-quality APIs, each with varying certifications and capacities. Strategic partnerships, rigorous supplier evaluation, and robust quality assurance protocols are essential to maintaining supply continuity and product integrity.

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Key Takeaways

• The legitimacy and quality of APIs are paramount; compliance with GMP and pharmacopeial standards is non-negotiable.

• Diversified sourcing minimizes supply chain risks, especially amid global disruptions.

• Engaging reputable manufacturers or certified CMOs ensures consistent API quality for ORTHO-NOVUM 10/11-28 production.

• Due diligence, including reviewing supplier certifications, batch records, and stability data, mitigates regulatory risks.

• Regular audits and quality assessments strengthen supply chain resilience for long-term product success.

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FAQs

1. How do I verify the authenticity of an API supplier?
Verify supplier certifications such as GMP, ISO, and pharmacopeial compliance. Request batch-specific Certificate of Analysis (CoA) and conduct audits or third-party assessments when possible.

2. Are Chinese API manufacturers suitable for producing APIs for regulated products like ORTHO-NOVUM?
Yes. Many Chinese manufacturers have obtained international GMP certifications and routinely supply APIs to global markets, including regulated ones, provided they meet stringent quality standards.

3. What are the risks of sourcing low-cost APIs?
Lower-cost APIs may pose risks related to substandard purity, contamination, variability, and regulatory non-compliance, which can compromise product safety and efficacy.

4. How often should API suppliers be audited?
Regular audits should occur at least annually, with additional unannounced inspections, especially when supplier quality or regulatory circumstances change.

5. Can emerging API suppliers fulfill the stringent quality requirements for contraceptive APIs?
Emerging suppliers can meet high-quality standards if they possess necessary certifications, robust quality systems, and transparent manufacturing practices.

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References

1. US Pharmacopeia. USP Monographs for Ethinyl Estradiol.
2. European Pharmacopoeia. Norgestimate Monographs.
3. Global API Market Reports. Smith, J. et al., "Trends in Hormone API Production," Pharmaceutical Industry Journal, 2022.
4. World Health Organization (WHO). Guidelines on Good Manufacturing Practices for Active Pharmaceutical Ingredients.
5. Company websites and official API catalogs of Novartis, Lupin, Teva, Zhejiang NHU, and others.

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