Bulk Pharmaceutical API Sources for JADELLE

Bulk Pharmaceutical API Sources for JADELLE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		284858_ALDRICH
Molport		MolPort-002-510-453
Amadis Chemical		A835065
Amadis Chemical		A839753
TCI (Tokyo Chemical Industry)		N0889
BioChemPartner		BCP9000852

Bulk Active Pharmaceutical Ingredient (API) Sources for JADELLE (Drospirenone and Ethinyl Estradiol)

Last updated: July 28, 2025

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Introduction

Jadelle, a long-acting contraceptive implant, primarily combines levonorgestrel—a synthetic progestogen. However, it appears there may be a mislabeling or confusion concerning the API involved, as Jadelle does not incorporate drospirenone or ethinyl estradiol, the components often associated with combined oral contraceptives. Instead, Jadelle comprises two silica rods releasing levonorgestrel, a progestogen used for contraception or hormone therapy.

This analysis clarifies the bulk API sourcing landscape for levonorgestrel—the key API used in Jadelle—and examines available suppliers, manufacturing considerations, and implications for pharmaceutical stakeholders. It also briefly discusses the relevance of drospirenone and ethinyl estradiol APIs within the context of combined contraceptives, which are often mistaken with Jadelle's formulation.

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Understanding Jadelle’s API Composition

Jadelle operates via subdermal implant technology, releasing levonorgestrel over a sustained period—up to five years[1]. Its core API is therefore levonorgestrel, a potent progestin with well-established pharmacokinetics and manufacturing protocols.

Drospirenone and ethinyl estradiol are APIs characteristic of combined oral contraceptives (COCs), not Jadelle. COCs typically incorporate drospirenone as the progestogen component and ethinyl estradiol as the estrogen component. However, for completeness, this report distinguishes between the API sources for levonorgestrel (Jadelle) and those for drospirenone/ethinyl estradiol COCs.

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Global API Sourcing for Levonorgestrel

Major API Manufacturers

1. Bayer AG (Germany)
   Bayer historically supplies levonorgestrel APIs, leveraging extensive R&D and manufacturing infrastructure to ensure API purity and compliance with pharmacopeial standards. Their manufacturing facilities are GMP-certified, serving both in-house production (for products like Jadelle) and external clients through licensing arrangements[2].

2. Hetero Labs Limited (India)
   A leading generic pharmaceuticals manufacturer, Hetero offers high-quality levonorgestrel APIs. Their facilities are WHO-GMP certified, and they have supply agreements with global contraceptive manufacturers. Hetero emphasizes cost competitiveness coupled with high API purity standards[3].

3. Sinochem Lunan Pharmaceutical (China)
   As a major Chinese drug intermediary-API producer, Sinochem Lunan supplies levonorgestrel of consistent quality to global markets. Their manufacturing process employs advanced chemistry and rigorous quality control to meet international standards[4].

4. Famar (Greece)
   A prominent manufacturer of sterile APIs, Famar produces levonorgestrel for both oral and implant formulations. Their facilities operate under strict GMP conditions, targeting European and international markets[5].

5. Remedica (Cyprus)
   Specializing in high-potency APIs, Remedica supplies levonorgestrel to multiple contraceptive product manufacturers. Their focus on regulatory compliance and supply chain robustness makes them a reliable source[6].

API Quality and Regulatory Considerations

Suppliers must meet standards set by pharmacopoeias such as USP, EP, or JP, ensuring API purity (>99%), low impurities, and consistent bioavailability. Additional certification, such as ISO or GMP compliance, enhances supply chain credibility—particularly critical for implantable APIs like levonorgestrel.

Supply Chain Dynamics

Global disruptions (e.g., COVID-19 pandemic, geopolitical tensions) highlight the importance of diversified sourcing strategies. Leading companies often maintain multiple API suppliers to mitigate risks and secure steady production of Jadelle implants.

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API Sourcing for Drospirenone and Ethinyl Estradiol

As per the scope of combined oral contraceptives, sourcing APIs for drospirenone and ethinyl estradiol involves distinct considerations:

1. Drospirenone is synthesized predominantly by Bayer and Synthesis, along with other specialized API producers. Bayer supplies high-purity drospirenone for both generics and proprietary formulations, complying with international regulations[7].

2. Ethinyl Estradiol APIs are produced by major manufacturers such as Dr. Reddy’s Laboratories, Mylan (now Viatris), and Sandoz. These producers operate GMP-certified facilities, ensuring high-quality estrogen APIs for contraceptive pills[8].

Note: While drospirenone and ethinyl estradiol APIs are accessible via numerous global suppliers, Jadelle’s API source remains strictly levonorgestrel.

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Manufacturing and Quality Control

The procurement of active pharmaceutical ingredients necessitates rigorous quality assessments, including:

• Identity testing: Confirming chemical structure via NMR, IR, or MS.
• Purity assessments: HPLC analysis to verify purity levels and impurity profiles compliant with pharmacopoeial standards.
• Residual solvents: Ensuring residual solvent levels remain within permissible limits.
• Batch consistency: Validating consistency across production runs.

Manufacturers often seek API suppliers with validated stability data and proven scalability, enabling consistent supply over extended periods—crucial for long-acting implant vendors like Jadelle.

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Implications for Stakeholders

• Manufacturers: Should prioritize API suppliers with a demonstrated track record of quality and regulatory compliance. Diversification across suppliers mitigates risks and secures uninterrupted production.
• Regulators: Require stringent documentation of API quality, adherence to Good Manufacturing Practices, and batch traceability.
• Distributors and Buyers: Should verify supplier certifications, audit reports, and consistency in API supply to avoid counterfeit or substandard ingredients.

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Key Takeaways

• Levonorgestrel is the primary API for Jadelle, supplied predominantly by Bayer, Hetero, Sinochem Lunan, Famar, and Remedica.
• Manufacturers demand APIs meeting international pharmacopoeial standards (USP, EP, JP) and GMP compliance for safe, effective hormone delivery.
• Diversification of API sources reduces supply chain risks, ensuring consistent Jadelle production.
• Drospirenone and ethinyl estradiol APIs are associated with combined contraceptives, not Jadelle, but are available from established global pharmaceutical manufacturers.
• Regulatory vigilance and thorough quality assurance processes are essential when sourcing APIs for implantable contraceptives.

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FAQs

1. What are the main API suppliers for levonorgestrel used in Jadelle?
Major suppliers include Bayer AG, Hetero Labs (India), Sinochem Lunan (China), Famar (Greece), and Remedica (Cyprus), all meeting strict GMP and pharmacopeial standards.

2. How does API quality impact Jadelle's safety and efficacy?
High-purity APIs with consistent batch quality ensure reliable hormone release, minimizing risks of adverse effects and ensuring contraceptive effectiveness.

3. Are there regional differences in API sourcing for Jadelle?
Yes. Leading Asian API producers (Hetero, Sinochem Lunan) offer cost-effective sourcing, while European suppliers (Bayer, Famar) emphasize higher regulatory compliance and quality standards.

4. Can API sourcing influence regulatory approval for Jadelle in different markets?
Absolutely. Authorities require documented compliance with GMP, rigorous quality testing, and supply chain transparency—all impacted by the API's origin and manufacturer.

5. Is drospirenone used in Jadelle?
No. Jadelle exclusively contains levonorgestrel. Drospirenone and ethinyl estradiol are components of combined oral contraceptives, not subdermal implants like Jadelle.

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References

[1] World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 5th ed., 2015.
[2] Bayer AG. Corporate Responsibility Report. 2022.
[3] Hetero Labs Limited. API Portfolio Overview. 2022.
[4] Sinochem Lunan Pharmaceutical. Annual Report. 2022.
[5] Famar. Manufacturing Capabilities for Hormonal APIs. 2021.
[6] Remedica. API Quality Assurance. 2022.
[7] Bayer AG. Drospirenone API Fact Sheet. 2021.
[8] Sandoz. Estrogen API Specifications. 2022.