Bulk Pharmaceutical API Sources for DYDROGESTERONE

Bulk Pharmaceutical API Sources for DYDROGESTERONE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		9051
ISpharm		I06-1088
MolPort		MolPort-005-940-416
ABI Chem		AC1L1S7M

Bulk Active Pharmaceutical Ingredient (API) Sources for Dydrogesterone

Last updated: July 28, 2025

Introduction

Dydrogesterone, a synthetic progestogen structurally related to natural progesterone, is widely used in hormone replacement therapy, treatment of menstrual disorders, and infertility management. As a critical component in pharmaceutical formulations, sourcing high-quality bulk API is paramount for manufacturers to ensure product efficacy, safety, and regulatory compliance. The global API supply chain for dydrogesterone involves multiple regions, with key manufacturers offering diverse sourcing options for pharmaceutical companies worldwide.

Global Manufacturing Landscape

The primary sources of dydrogesterone API are concentrated in regions with well-established pharmaceutical industries, notably India, China, and Europe. Indian pharmaceutical companies dominate the market, supported by the country's robust regulatory environment, capacity for large-scale manufacturing, and cost advantages. Chinese API producers also play a significant role, providing a mix of generic and proprietary APIs. European manufacturers offer high-purity, GMP-compliant API supplies, often catering to markets with stringent regulatory standards.

Major API Manufacturers of Dydrogesterone

1. Indian API Producers

a) GVK Biosciences (GKV Biosciences)
GKV Biosciences is a leading contract manufacturer and API supplier based in India, known for its comprehensive portfolio including hormonal APIs such as dydrogesterone. Their facilities are GMP-certified, and they emphasize quality control, making them a preferred partner for global pharmaceutical companies.

b) Laurus Labs
Laurus Labs specializes in the production of hormonal APIs, including dydrogesterone. Their facilities are approved by major regulatory bodies, and they offer competitive pricing coupled with consistent quality. The company's strategic investments enable large-volume production.

c) Hetero Drugs
Hetero is a prominent pharmaceutical API manufacturer with a focus on hormonal and steroid APIs. Their manufacturing facilities are compliant with international standards, and they export dydrogesterone APIs globally.

d) Norm Pharmaceuticals
Based in India, Norm Pharmaceuticals produces dydrogesterone API with an emphasis on quality and regulatory compliance, supporting both domestic and international markets.

2. Chinese API Manufacturers

a) Jiangsu Hedong Pharmaceutical Co., Ltd.
This Chinese API manufacturer supplies dydrogesterone with high purity and GMP compliance, serving pharmaceutical clients across Asia and beyond. Their production capacity and quality assurance protocols make them a reliable source.

b) Zhejiang Xinhua Pharmaceutical Co., Ltd.
Specializing in hormone APIs, Zhejiang Xinhua offers dydrogesterone with assured quality standards and competitive pricing. Their GMP-certified facilities adhere to international requirements, making them a credible source for global markets.

c) North China Pharmaceutical Group Corporation (NCPC)
An established Chinese pharmaceutical enterprise, NCPC supplies dydrogesterone API that meets international GMP standards, emphasizing innovation and quality.

3. European API Suppliers

a) Delpharm
A European manufacturing group, Delpharm produces high-quality dydrogesterone APIs with strict adherence to European GMP standards, serving clients requiring high regulatory standards.

b) Famar Healthcare Services
Based in France, Famar offers custom synthesis and manufacturing of dydrogesterone API, supporting both clinical and commercial supply chains with premium quality APIs.

c) Aeterna Zentaris
Although primarily a specialty pharmaceutical company, Aeterna Zentaris’ manufacturing subsidiaries supply high-grade dydrogesterone APIs to niche markets demanding stringent quality standards.

APIs from Contract Manufacturing Organizations (CMOs)

In addition to primary manufacturers, numerous CMOs globally offer dydrogesterone API production services. These entities typically leverage partnerships with established API producers to ensure quality and volume needs are met efficiently.

Key CMO Providers include companies such as:

• Bg Affairs (India, China)
• Genscript (USA/Asia)
• Xenon Pharmaceuticals (Europe)

Such collaborations enable pharmaceutical firms to diversify sourcing while maintaining quality and cost control.

Quality and Regulatory Considerations

When sourcing dydrogesterone API, entities must evaluate suppliers on GMP certification, purity levels (typically >99%), batch consistency, and their compliance with regulatory agencies like the U.S. FDA, EMA, or PMDA. The choice hinges on quality assurance, regulatory acceptance, supply stability, and cost.

Market Trends and Future Outlook

The dydrogesterone API market is poised for growth driven by the rising demand for hormone-based therapeutics. Asian manufacturers are expanding capacities, investing in CGMP upgrades, and pursuing regulatory approvals in Western markets to meet quality standards. The shift toward biosimilar and generic formulations further amplifies the importance of reliable, high-volume API sources.

Conclusion

Global sourcing options for dydrogesterone API are extensive, with Indian and Chinese manufacturers dominating the low to mid-range market segments owing to their cost advantage and scaling capabilities. European suppliers focus on high-purity, high-standard APIs suitable for stringent regulatory markets. Companies should prioritize suppliers with GMP certification, proven regulatory track records, and robust quality controls.

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Key Takeaways

• Indian and Chinese manufacturers are the primary sources for cost-effective dydrogesterone API, with GMP-certified facilities ensuring international compliance.
• European suppliers cater to markets with strict regulatory requirements, offering high-purity APIs tested against stringent standards.
• Strategic partnerships with reputable CMOs expand sourcing flexibility, foster innovation, and mitigate supply chain risks.
• Ensuring API quality, regulatory adherence, and supply reliability remains critical when selecting manufacturing partners.
• Market growth forecasts justify ongoing investments in capacity expansion, quality improvements, and regulatory approvals from key Asian manufacturers.

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Frequently Asked Questions

Q1: What are the main factors to consider when choosing a dydrogesterone API supplier?
A1: Key factors include GMP certification, API purity (>99%), production capacity, regulatory compliance, quality control processes, lead times, and cost competitiveness.

Q2: Are there any regulatory restrictions on sourcing dydrogesterone API from China or India?
A2: While many reputable manufacturers from India and China hold GMP certifications and meet international standards, some markets require rigorous validation and audit processes to authenticate supplier compliance, especially for high-regulatory environments like the EU and US.

Q3: How does API purity impact the efficacy of dydrogesterone products?
A3: Higher purity API (>99%) minimizes impurities that could affect drug efficacy or induce adverse reactions, ensuring safety, regulatory approval, and consistent therapeutic outcomes.

Q4: Is there a trend toward local manufacturing of dydrogesterone API?
A4: Yes, some regions are incentivizing local production to enhance supply security, reduce dependency on imports, and meet regional regulatory standards, though globally, Asian manufacturers remain dominant.

Q5: What is the typical lead time for sourcing dydrogesterone API?
A5: Lead times vary based on supplier and order volume but generally range from 8 to 16 weeks, considering production, quality testing, and logistics.

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Sources

1. [1] Indian API Manufacturers Directory, Indian Pharmaceutical Association (2022).
2. [2] Chinese API Industry Report, China Institute of Resources and Environmental Policies (2022).
3. [3] European Pharmacopoeia, Pharmacovigilance Standards for Hormonal APIs, (2022).
4. [4] Global API Market Analysis, IQVIA Reports (2022).
5. [5] Regulatory Guidance for API Sourcing, U.S. FDA and EMA Official Protocols (2022).