Bulk Pharmaceutical API Sources for ORTHO-NOVUM 7/14-28

Bulk Pharmaceutical API Sources for ORTHO-NOVUM 7/14-28

Vendor	Vendor Homepage	Vendor Sku	API Url
ABI Chem		AC1L1Y1Y
ChemMol		99075529
THE BioTek		bt-277561
BenchChem		B1679912

Bulk Active Pharmaceutical Ingredient (API) Sources for ORTHO-NOVUM 7/14-28

Last updated: August 2, 2025

Introduction

Orthoe-NOVUM 7/14-28 is a combination oral contraceptive comprising ethinyl estradiol and norgestimate. Its efficacy hinges on the quality, purity, and consistency of its active pharmaceutical ingredients (APIs). Access to reliable bulk API sources is pivotal for pharmaceutical manufacturers seeking to produce high-quality, compliant contraceptives. This report provides an in-depth look at sources for the key APIs—ethinyl estradiol and norgestimate—highlighting global manufacturers, quality assurances, regulatory considerations, and procurement strategies.

---

Ethinyl Estradiol: The Estrogenic Component

Manufacturers and Suppliers

Ethinyl estradiol (EE) is a synthetic estrogen used in various oral contraceptives. Major API producers include:

• BASF (Germany): One of the leading global chemical suppliers, BASF offers high-purity EE for pharmaceutical applications, complying with ICH guidelines. Their facilities adhere to current Good Manufacturing Practices (cGMP), certifying quality and regulatory compliance.

• Mitsubishi Chemical (Japan): Known for advanced synthesis capabilities, Mitsubishi provides pharmaceutical-grade EE, ensuring consistent potency and purity suitable for oral contraceptives.

• Synthesis-Pharma (India): Several Indian API manufacturers, such as Symbiochem (a division of Cipla), produce pharmaceutical-grade EE, often at competitive prices due to regional manufacturing advantages.

• Jiangsu Hetero Labs (China): Offers bulk EE suitable for generic contraceptives, with global export licenses and compliance with international standards.

Quality Certifications and Regulatory Compliance

Providers typically furnish certificates of analysis (CoA) aligning with USP, EP, or JP standards. Manufacturers often hold cGMP certifications, ISO accreditation, and compliance with international regulatory bodies like the FDA, EMA, and PMDA.

Procurement Considerations

• Regulatory approval hinges on API documentation, stability data, and batch consistency.
• Supply chain reliability is crucial; established suppliers with validated manufacturing processes minimize regulatory and quality risks.
• Regional pricing varies; Asian suppliers tend to offer cost advantages, but import compliance and logistical considerations should guide selection.

---

Norgestimate: The Progestogenic Agent

Manufacturers and Suppliers

Norgestimate, a progestin, is less widely manufactured than EE but remains critical in combination contraceptives:

• Gedeon Richter (Hungary): A proven supplier of norgestimate, with global distribution and regulatory approval in multiple jurisdictions.

• Mitsubishi Chemical (Japan): Also involved in norgestimate production, collaborating on high-quality API synthesis.

• Hetero Labs (India): Manufactures pharmaceutical-grade norgestimate, with export licenses and adherence to international standards.

• Leebron Pharmaceuticals (India): Specializes in various steroid APIs, including norgestimate, offering competitive pricing for large-volume procurement.

Quality and Regulatory Assurance

Suppliers typically provide CoA, stability data, and demonstrate compliance with pharmacopeial standards such as USP and EP. Suppliers’ cGMP certification and existing regulatory approvals streamline validation for generic ORTHO-NOVUM products.

Supply Dynamics

The relatively niche market for norgestimate makes sourcing less diversified than EE but stable from established manufacturers. Regional suppliers from Asia and Europe provide options that balance quality, cost, and delivery timelines.

---

Regional API Market Analysis

The Asian API manufacturing hub dominates global supply for both EE and norgestimate due to cost efficiencies, technical expertise, and regulatory capabilities. Indian and Chinese manufacturers are particularly prominent, offering APIs compliant with international standards, including FDA, EMA, and WHO prequalification.

European and North American suppliers tend to focus on high-end, phase-specific, or specialized APIs with stringent quality controls, often catering to branded pharmaceutical companies.

Regulatory Considerations

• Manufacturers must comply with cGMP and obtain certification from recognized authorities.
• Importing APIs into regulated markets like the U.S. and Europe requires comprehensive documentation, including CoA, stability data, and traceability records.
• Validation batches and bioequivalence studies are prerequisites for generic formulation approval.

Supply Chain and Risk Management

Diversification of sources mitigates supply disruptions. Critical APIs should be procured from multiple certified suppliers. Analytical testing and audit due diligence are essential parts of supplier qualification procedures.

---

Procurement Strategies and Best Practices

• Engage with API manufacturers early to establish supply agreements.
• Verify supplier compliance with GMP, ISO standards, and pharmacopoeial monographs.
• Conduct supplier audits, especially for Asian manufacturers, to ensure quality management systems are robust.
• Establish quality agreements delineating specifications, certification, and testing protocols.
• Maintain buffer stock and monitor global supply chain risks, such as geopolitical shifts or raw material shortages.

---

Conclusion

Reliable bulk API sourcing for ORTHO-NOVUM 7/14-28 hinges on sourcing from established, compliant manufacturers of ethinyl estradiol and norgestimate. European and North American suppliers offer high assurance but often at premium costs, whereas Asian manufacturers present economical alternatives with comparable quality. Strategic supplier qualification, diligent due diligence, and adherence to regulatory standards are vital for sustained API quality and supply continuity.

---

Key Takeaways

• The primary APIs for ORTHO-NOVUM 7/14-28 are ethinyl estradiol and norgestimate, sourced globally from both established Western and emerging Asian manufacturers.
• European suppliers like BASF and Gedeon Richter are premium sources, often preferred for their rigorous quality standards.
• Asian manufacturers, predominantly from India and China, offer competitive options but require careful validation regarding quality control and regulatory compliance.
• Procurement success depends on supplier qualification, adherence to cGMP, and comprehensive documentation aligned with international pharmacopeial standards.
• Diversifying sources and conducting risk assessments are critical tactics to ensure a stable, compliant supply of high-quality APIs.

---

FAQs

1. What are the critical quality attributes for APIs used in oral contraceptives?
High purity, potency, stability, consistent particle size, and compliance with pharmacopeial standards (USP, EP, JP) are essential attributes. Certificates of analysis, stability data, and proper manufacturing process validation underpin API quality.

2. How does regional manufacturing influence API sourcing for contraceptives?
Regional manufacturing affects cost, lead times, regulatory compliance, and quality assurance. European and North American suppliers generally demonstrate rigorous standards but at higher costs, whereas Asian suppliers offer cost-effective solutions with appropriate vetting.

3. What regulatory considerations are involved in importing APIs for contraceptive production?
Regulatory considerations include verifying suppliers' compliance with cGMP, obtaining necessary certifications, providing comprehensive documentation, and adhering to import licensing requirements in the target market.

4. How can manufacturers mitigate risks associated with API supply chain disruptions?
Diversify supplier base, conduct regular audits, establish strong quality agreements, hold safety stock, and maintain transparent communication with suppliers.

5. Are there proprietary or patent restrictions affecting API sourcing for ORTHO-NOVUM?
Most APIs used in generic contraceptives like ORTHO-NOVUM are off-patent. However, manufacturers must ensure that their sourcing complies with local patent laws and that API manufacturing agreements do not infringe on existing intellectual property rights.

---

Sources:

[1] World Health Organization, WHO Prequalification of Medicines Programme.
[2] U.S. Pharmacopeia, Official Monographs for Ethinyl Estradiol.
[3] European Pharmacopoeia, Monographs for Ethinyl Estradiol and Norgestimate.
[4] BASF, Product Information for Ethinyl Estradiol.
[5] Gedeon Richter, API Portfolio.