Bulk Pharmaceutical API Sources for ORTHO-NOVUM 10/11-21

Bulk Pharmaceutical API Sources for ORTHO-NOVUM 10/11-21

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 10/11-21

Last updated: July 28, 2025

Introduction

The pharmaceutical industry's evolution hinges on reliable, high-quality Active Pharmaceutical Ingredients (APIs). For combined oral contraceptives such as ORTHO-NOVUM 10/11-21, sourcing API components—namely norethindrone and ethinyl estradiol—is pivotal. These APIs must meet regulatory standards for purity, potency, and stability, as they form the core substances in the manufacturing process. This report provides an overview of key bulk API suppliers, highlighting their manufacturing capabilities, compliance standards, and strategic advantages pertinent to ORTHO-NOVUM 10/11-21.

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Active Pharmaceutical Ingredients in ORTHO-NOVUM 10/11-21

ORTHO-NOVUM 10/11-21 is a combined contraceptive containing:

• Norethindrone: a synthetic progestin stabilizing the hormonal cycle.
• Ethinyl Estradiol: a synthetic estrogen used to inhibit ovulation.

The efficacy of ORTHO-NOVUM 10/11-21 directly correlates with the quality and consistency of these APIs.

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Global API Manufacturers for Ethinyl Estradiol and Norethindrone

1. Pfizer Inc.

• Overview: Pfizer remains a dominant supplier of high-purity APIs, including ethinyl estradiol and norethindrone, leveraging decades of manufacturing expertise.
• Capabilities: Integrated R&D, cGMP-certified production plants, consistent quality assurance.
• Compliance: Adheres to FDA, EMA standards, and WHO GMP certifications, ensuring regulatory compliance globally ([1]).

2. Teva Pharmaceutical Industries Ltd.

• Overview: A major global generics producer, Teva supplies bulk APIs, including ethinyl estradiol, with robust manufacturing infrastructure.
• Strengths: Vertical integration allows control over quality and supply chain.
• Standards: Certified cGMP facilities compliant with international norms, with a focus on reproductive health APIs ([2]).

3. Novartis AG

• Overview: Novartis manufactures both ethinyl estradiol and norethindrone, emphasizing high-quality standards in API production.
• Manufacturing: State-of-the-art facilities with extensive process validation to ensure batch-to-batch consistency.
• Regulatory: Meets ICH, FDA, EMA regulatory requirements, making them a reliable supplier for commercial manufacturing ([3]).

4. Mylan (now part of Viatris)

• Overview: Mylan, acquired by Viatris, supplies APIs for oral contraceptives, including norethindrone and ethinyl estradiol.
• Strengths: Cost-effective manufacturing in multiple regions, including India and Europe.
• Compliance: GMP-certified plants adhering to international standards suitable for global distribution ([4]).

5. Aurobindo Pharma

• Overview: An Indian-based manufacturer recognized for high-volume API production, including hormones for contraceptive use.
• Advantages: Competitive pricing, extensive API portfolio, and compliance with USFDA, EMA, and WHO standards.
• Supply Reliability: Large-scale manufacturing ensures consistent supply for markets worldwide ([5]).

6. Zhuhai United Laboratories

• Overview: Chinese manufacturer specializing in hormonal APIs, including ethinyl estradiol.
• Strengths: Competitive pricing, flexible production scales, adherence to cGMP.
• Regulatory Status: Increasingly recognized for compliance with international standards, though regulatory acceptance varies by market ([6]).

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Emerging and Niche API Suppliers

7. GVK Biosciences

• Overview: An India-based API producer focusing on hormone APIs with validated cGMP production.
• Advantages: Cost-effective, robust quality assurance protocols, suitable for generic contraceptive products ([7]).

8. Piramal Healthcare

• Overview: Known for high-quality hormone APIs, including norethindrone, with multiple manufacturing facilities.
• Compliance: Fully compliant with global regulatory standards, with deep expertise in analytical characterization ([8]).

9. Hetero Drugs

• Overview: A major Indian pharmaceutical manufacturer supplying APIs for contraceptive formulations.
• Strengths: Competitive pricing, proven manufacturing processes, and supply chain robustness ([9]).

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Key Considerations for API Sourcing in ORTHO-NOVUM 10/11-21

• Quality Assurance: Strict adherence to cGMP, ICH guidelines, and 3rd-party audits are essential to mitigate regulatory risks.
• Regulatory Documentation: Certificates of Suitability (CEP), Drug Master Files (DMFs), and thorough analytical data support regulatory submissions.
• Supply Chain Reliability: Diversification of sources minimizes risks related to geopolitical issues, capacity constraints, or supply disruptions.
• Pricing and Flexibility: Suppliers offering flexible batch sizes, competitive pricing, and logistical support can enhance operational efficiency.

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Conclusion

Sourcing APIs for ORTHO-NOVUM 10/11-21 demands a combination of quality assurance, regulatory compliance, supply reliability, and cost-effectiveness. Leading global suppliers such as Pfizer, Teva, and Novartis offer proven quality and regulatory compliance, suitable for geopolitically sensitive markets. Indian manufacturers like Aurobindo, Hetero, and Piramal provide cost-effective options with rapidly growing regulatory acceptance. Emerging Chinese suppliers are gaining ground, providing flexible, competitively priced alternatives. Strategic diversification across these sources can help pharmaceutical firms optimize supply chains, reduce risks, and ensure uninterrupted production of this critical contraceptive.

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Key Takeaways

• Prioritize suppliers with proven compliance to international standards such as FDA, EMA, and WHO GMP.
• Maintain a diversified supplier portfolio to mitigate geopolitical, regulatory, or capacity-related risks.
• Incorporate comprehensive quality assurance and regulatory documentation checks to streamline approvals.
• Consider cost, supply stability, and market-specific regulatory acceptance when selecting API sources.
• Emerging markets like India and China are becoming central in global API supply chains, but due diligence remains essential.

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FAQs

1. What are the primary APIs in ORTHO-NOVUM 10/11-21?
The primary active ingredients are norethindrone (a progestin) and ethinyl estradiol (an estrogen).

2. Which manufacturers are considered the most reliable API sources for contraceptives?
Pfizer, Novartis, Teva, and Mylan are among the most established, providing high-quality APIs with global regulatory approvals.

3. How important is regulatory compliance in selecting API suppliers?
It is critical, as non-compliance can delay approvals, impact product efficacy, or lead to regulatory sanctions. Ensuring suppliers meet cGMP, ICH, and other standards is mandatory.

4. Can emerging API suppliers in India and China meet quality standards?
Yes, many have achieved certifications such as USFDA, EMA, and WHO GMP, but due diligence and audits are essential to validate their compliance.

5. What risks are associated with API sourcing, and how can they be mitigated?
Supply disruptions, quality variations, and regulatory non-compliance pose risks. Diversifying suppliers, conducting audits, and securing comprehensive documentation mitigate these risks.

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Sources

1. Pfizer Annual Report, 2022.
2. Teva Corporate Website, API Portfolio.
3. Novartis API manufacturing capabilities.
4. Viatris (formerly Mylan) API Certifications, 2022.
5. Aurobindo Pharma API Quality Assurance.
6. Zhuhai United Laboratories. GMP Certification Report.
7. GVK Biosciences API Quality Profile.
8. Piramal Healthcare API Approvals.
9. Hetero Drugs API Portfolio and Certifications.