Bulk Pharmaceutical API Sources for TRIVORA-28

Bulk Pharmaceutical API Sources for TRIVORA-28

Vendor	Vendor Homepage	Vendor Sku	API Url
J&H Chemical Co.,ltd		JH285923
RR Scientific		R207957
AKos Consulting & Solutions		AKOS040751734
EvitaChem		evt-267826
BOC Sciences		8056-51-7
TargetMol		T31699
InvivoChem		V20777

Bulk Active Pharmaceutical Ingredient (API) Sources for: TRIVORA-28

Last updated: July 28, 2025

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Overview of TRIVORA-28

TRIVORA-28 is a combined oral contraceptive pill composed of ethinyl estradiol and levonorgestrel. As a widely prescribed hormonal contraceptive, it relies on high-quality APIs—ethinyl estradiol and levonorgestrel—to ensure efficacy, safety, and regulatory compliance. Securing reliable bulk API sources is paramount for pharmaceutical manufacturers aiming to produce TRIVORA-28 with consistent potency, purity, and stability.

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Active Pharmaceutical Ingredients in TRIVORA-28

1. Ethinyl Estradiol (EE)

• A synthetic estrogen used in contraceptives.
• Mechanism: suppression of ovulation through feedback inhibition on the hypothalamic-pituitary-gonadal axis.

2. Levonorgestrel (LNG)

• A synthetic progestogen.
• Mechanism: prevents ovulation, modifies cervical mucus, and thins the endometrial lining.

Both APIs require strict quality standards due to their hormonal potency and potential side effects if impurities are present.

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Global API Suppliers for Ethinyl Estradiol

1. Teva Pharmaceuticals

• One of the largest API manufacturers globally.
• Offers high-grade ethinyl estradiol used in oral contraceptives, including TRIVORA-28.
• Facilities: Israel, USA, and manufacturing sites compliant with cGMP standards.

2. Zhejiang Huahai Pharmaceutical Co., Ltd.

• Major Chinese API producer.
• Supplies bulk ethinyl estradiol conforming to international pharmacopoeias.
• Recognized for cost competitiveness and reliable supply.

3. Samsung BioPharmaceuticals

• South Korean biotech company with advanced API manufacturing capabilities.
• Provides bulk ethinyl estradiol with consistent quality profiles suitable for oral contraceptive products.

4. Mylan (now part of Viatris)

• Global pharmaceutical leader.
• Supplies high-quality ethinyl estradiol APIs with comprehensive quality control and regulatory dossiers.

5. Sandoz (Novartis division)

• Reputed for quality APIs.
• Supplies ethinyl estradiol suitable for oral contraceptive formulations with global regulatory approvals.

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Global API Suppliers for Levonorgestrel

1. Sun Pharma Advanced Research Company

• A prominent Indian pharmaceutical manufacturer.
• Supplies levonorgestrel with high purity standards, validated for use in contraceptive products.

2. Fertin Pharma

• A leading manufacturer of levonorgestrel APIs.
• Known for consistent quality, compliance with ICH and pharmacopoeial standards.

3. Mylan / Viatris

• Supplies well-characterized levonorgestrel bulk APIs globally.
• Offers pipelines aligned with regulatory standards like FDA and EMA.

4. Hetero Labs

• Indian API producer with a wide portfolio including levonorgestrel.
• Provides APIs with comprehensive quality documentation.

5. Aurobindo Pharma

• Manufacturers of levonorgestrel API with strict adherence to cGMP and ISO standards.
• Serves global markets with reliable supply chains.

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Quality and Regulatory Considerations

Selecting API suppliers for TRIVORA-28 requires adherence to rigorous regulatory standards including:

• Pharmacopoeial compliance: APIs must meet USP, EP, or JP specifications.
• GMP certification: Ensuring manufacturing processes meet Good Manufacturing Practices.
• Purity and potency: APIs should exhibit purity levels >99%, with specified impurity limits.
• Characterization: Detailed analytical data, including IR, NMR, HPLC profiles, and stability data.
• Supply chain integrity: Reliable and traceable shipment pathways to mitigate risks of contamination or adulteration.

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Emerging Trends and Future Outlook

The API supply landscape for hormonal contraceptives like TRIVORA-28 is evolving owing to:

• Manufacturing diversification: To mitigate geopolitical or supply chain disruptions, companies are diversifying sources, including regional suppliers.
• Advanced synthesis methods: Improved synthetic routes are reducing impurity profiles and enhancing yield.
• Regulatory harmonization: Increasing alignment of API standards across regions simplifies approval processes and enhances global supply security.
• Sustainability initiatives: Growing emphasis on environmentally sustainable production, including reduction of hazardous waste and energy consumption.

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Conclusion

Securing high-quality bulk APIs for TRIVORA-28 hinges on selecting reputable suppliers with proven regulatory compliance, consistent supply chain reliability, and robust quality control practices. Leading manufacturers such as Teva, Mylan, Sun Pharma, and regional suppliers in China and India continue to dominate the supply of ethinyl estradiol and levonorgestrel. The dynamic regulatory environment and global health considerations necessitate continuous evaluation of suppliers to ensure supply chain integrity and product efficacy.

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Key Takeaways

• Global diversification reduces dependency on single-source suppliers for APIs used in TRIVORA-28.
• Regulatory compliance is critical—API suppliers must meet cGMP and pharmacopoeial standards.
• Quality assurance involves verifying purity, potency, and impurity profiles before sourcing bulk APIs.
• Emerging innovations in API synthesis improve supply stability, reduce costs, and enable sustainable manufacturing.
• Strategic sourcing entails balancing cost, quality, and regulatory compliance to optimize product quality and market availability.

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FAQs

1. What are the primary factors to consider when sourcing APIs for TRIVORA-28?
Quality standards, regulatory compliance, supply chain reliability, cost-effectiveness, and supplier reputation are essential considerations.

2. How do I verify the quality of bulk APIs for hormonal contraceptives?
Request comprehensive Certificate of Analysis (CoA), review analytical method validation data, ensure adherence to pharmacopoeial standards, and perform supplier audits if needed.

3. Are there regional differences in API suppliers’ regulatory acceptance?
Yes. While many suppliers meet international standards, some regions may require additional regulatory filings or approvals, emphasizing the importance of compliance with local regulatory agencies like the FDA or EMA.

4. How do supply chain disruptions affect API sourcing for TRIVORA-28?
Disruptions can lead to shortages, impacting production schedules and market availability. Diversification of suppliers and maintaining strategic stockpiles mitigate these risks.

5. What innovations are improving API manufacturing for hormonal contraceptives?
Advancements include synthetic route optimization, process intensification, greener chemistry practices, and automation, which collectively enhance purity, yield, and sustainability.

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References

1. U.S. Pharmacopeia. (2022). USP Monographs for Ethinyl Estradiol and Levonorgestrel.
2. European Pharmacopoeia. (2022). EP Standards for Hormonal APIs.
3. Global API Suppliers’ Public Disclosures and Certification Data.
4. Industry Reports on API Market Trends, 2022-2023.
5. Regulatory Agency Guidelines (FDA, EMA) on API Manufacturing Practices.