Bulk Pharmaceutical API Sources for PREVEN EMERGENCY CONTRACEPTIVE KIT

Bulk Pharmaceutical API Sources for PREVEN EMERGENCY CONTRACEPTIVE KIT

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: PREVEN EMERGENCY CONTRACEPTIVE KIT

Last updated: August 8, 2025

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Introduction

The Preven Emergency Contraceptive Kit, primarily containing levonorgestrel, functions as a post-coital contraceptive aimed at preventing pregnancy following unprotected sex or contraceptive failure. The pharmaceutical manufacturing of such kits necessitates the procurement of high-grade Active Pharmaceutical Ingredients (APIs) that comply with stringent regulatory standards. Identifying reputable bulk API suppliers is crucial for ensuring product efficacy, safety, regulatory compliance, and cost-effectiveness.

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Overview of API Requirements for Preven Emergency Contraceptive

The core API for Preven is levonorgestrel, a progestin hormone that inhibits ovulation and fertilization. The API must adhere to strict purity, potency, and stability standards, typically described in pharmacopeial monographs such as the USP, EP, or JP. Suppliers must demonstrate Good Manufacturing Practice (GMP) compliance, reliable sourcing, and transparency in supply chain.

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Global API Suppliers for Levonorgestrel

1. Major Pharmaceutical API Manufacturers

a) Boehringer Ingelheim
Boehringer Ingelheim, based in Germany, is a leading producer of hormonal APIs, including levonorgestrel. The company maintains rigorous GMP standards and offers high-purity APIs suitable for contraceptive formulations. Their APIs are globally supplied to pharmaceutical firms meeting quality standards.

b) Pfizer Inc.
Pfizer's extensive API manufacturing division supplies levonorgestrel globally. Their APIs meet international pharmacopeial standards, with a proven track record of regulatory approval across major markets.

c) Gedeon Richter Plc.
Hungarian pharmaceutical firm Gedeon Richter produces levonorgestrel APIs with high quality and reliability, serving both generic and branded contraceptive products globally.

d) Siegfried AG
Siegfried, headquartered in Switzerland, offers a portfolio of hormonal APIs, including levonorgestrel, with an emphasis on quality control and supply chain stability.

e) Hetero Labs Ltd.
An Indian pharmaceutical company, Hetero, supplies levonorgestrel APIs to global markets. Their API manufacturing adheres to WHO-GMP standards, ensuring quality and scalability.

2. Emerging and Regional API Suppliers

a) Sun Pharmaceutical Industries Ltd.
India-based Sun Pharma produces levonorgestrel APIs, with a focus on cost competitiveness and adherence to international standards.

b) Yunnan Baiyao Group Co., Ltd.
A Chinese pharmaceutical firm offering hormone APIs, including levonorgestrel, with competitive pricing for regional and export markets.

c) Accord Healthcare
A well-established generics producer with API manufacturing capabilities, providing levonorgestrel suitable for contraceptive products.

d) Zhejiang Hisun Pharmaceutical Co., Ltd.
Chinese supplier with GMP-certified APIs, catering to the global contraceptive API market.

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Key Attributes for API Suppliers

• GMP Certification: Ensures manufacturing processes meet quality standards.
• Regulatory Compliance: APIs should be compliant with USP, EP, or JP monographs.
• Purity & Potency: Usually >99.5% purity according to pharmacopeial standards.
• Supply Stability: Ability to fulfill large-volume orders consistently.
• Transparency & Traceability: Detailed documentation and batch records.

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Supply Chain Considerations

Selecting the right API supplier extends beyond initial qualification; ongoing reliability is vital. Suppliers with vertically integrated supply chains often offer better quality assurance. Documentation, including Certificates of Analysis (CoA), stability data, and lot-specific reports, is mandatory for regulatory filings. In addition, supplier audits and third-party quality verifications enhance procurement security.

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Regulatory and Quality Assurance

APIs intended for emergency contraceptive products, particularly those available over-the-counter or via sensitive regulatory pathways, necessitate rigorous quality control. Import regulations vary, with agencies such as the FDA (USA), EMA (Europe), and PMDA (Japan) requiring comprehensive validation. Suppliers must demonstrate traceability, consistency, and adherence to current Good Manufacturing Practices.

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Cost and Procurement Dynamics

Pricing for levonorgestrel APIs varies across regions, driven by factors such as scale, manufacturing costs, and regulatory requirements. Indian and Chinese suppliers generally offer competitive pricing but must be coupled with diligent quality assurance efforts. Meanwhile, European suppliers often command premium prices but provide high assurance levels for regulated markets.

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Conclusion

The procurement of bulk APIs for Preven emergency contraceptive kits centers on high-quality levonorgestrel sources. Leading global manufacturers like Boehringer Ingelheim, Pfizer, and Gedeon Richter are preferred for their consistency and regulatory compliance. Regional suppliers offer cost-effective alternatives, especially suited for developing markets. Strategic selection hinges on quality, regulatory adherence, supply stability, and cost considerations vital for pharmaceutical companies and generic manufacturers aiming to deliver safe, effective, and compliant emergency contraceptives.

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Key Takeaways

• Prioritize GMP-certified API suppliers to ensure regulatory compliance and product quality.
• Leverage relationships with established global manufacturers like Boehringer Ingelheim and Pfizer for assured supply and consistency.
• Consider regional suppliers for cost-sensitive markets, verifying GMP adherence and consistent quality.
• Ensure rigorous documentation and traceability to facilitate regulatory approvals in target markets.
• Maintain a diversified supply chain to mitigate risks related to supply disruptions or regulatory changes.

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FAQs

1. Why is API purity critical for Preven emergency contraceptive kits?
High purity, typically >99.5%, ensures the API's safety and efficacy, minimizing the risk of adverse reactions and ensuring consistent pharmacological action.

2. What regulatory standards govern levonorgestrel APIs?
APIs must comply with pharmacopeial standards such as USP, EP, or JP, along with GMP certification. Regulatory agencies like the FDA and EMA scrutinize manufacturing practices and quality documentation.

3. How can I verify the quality of an API supplier?
Request Certificates of Analysis, conduct supplier audits, review GMP certifications, and verify compliance through third-party quality assessments or regulatory inspections.

4. Are regional API suppliers reliable for global supply chains?
Many regional suppliers, especially from India and China, are reliable if they adhere to GMP standards and provide consistent quality documentation. Long-term partnerships and supplier audits are advisable.

5. What are cost considerations when sourcing APIs for emergency contraceptives?
While cost is significant, ensuring API quality and regulatory compliance outweigh price factors. Bulk procurement, supplier negotiation, and sourcing from established manufacturers optimize costs without compromising quality.

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References

[1] United States Pharmacopeia (USP). Levonorgestrel Monograph. 2022.

[2] European Pharmacopoeia (EP). Levonorgestrel Monograph. 2022.

[3] Gedeon Richter Plc. API quality standards documentation. 2022.

[4] Pfizer Inc. API manufacturing information, regulatory filings. 2022.

[5] World Health Organization. WHO Good Manufacturing Practices (GMP) guidelines. 2022.