Bulk Pharmaceutical API Sources for CLOMIPHENE CITRATE

Bulk Pharmaceutical API Sources for CLOMIPHENE CITRATE

Vendor	Vendor Homepage	Vendor Sku	API Url
Amadis Chemical		A826128
Finetech Industry Limited		FT-0603204
BOC Sciences		50-41-9
AKos Consulting & Solutions		AKOS030228551

Bulk Active Pharmaceutical Ingredient (API) Sources for Clomiphene Citrate

Last updated: August 5, 2025

Introduction

Clomiphene citrate is a non-steroidal fertility drug widely used in reproductive medicine to induce ovulation in women with ovulatory dysfunction. As a selective estrogen receptor modulator (SERM), it stimulates endogenous gonadotropin production, thereby promoting follicular development. The global demand for clomiphene citrate drives a complex supply chain of its active pharmaceutical ingredient (API), involving various manufacturing sources, primarily located in China, India, and established pharmaceutical hubs. Recognizing reliable API sources is crucial for pharmaceutical companies, generic drug manufacturers, and research entities seeking quality assurance, regulatory compliance, and cost-effectiveness.

This article comprehensively reviews major bulk API suppliers for clomiphene citrate, emphasizing supply chain dynamics, quality standards, regulatory statuses, and market trends.

---

Global API Manufacturing Landscape for Clomiphene Citrate

1. Dominance of Chinese API Producers

China is the primary global supplier of pharmaceutical APIs, including clomiphene citrate. The country's API manufacturing sector benefits from mature chemical industries, large-scale manufacturing infrastructure, and cost advantages. Notable Chinese companies producing clomiphene citrate API include:

• Zhejiang Haimeng Pharmaceutical Co., Ltd.
• Qingdao Zeyu Medicine Co., Ltd.
• Shandong Xinhua Pharmaceutical Co., Ltd.

These entities have invested in robust chemical synthesis processes, adhering to Good Manufacturing Practices (GMP), although regulatory oversight varies.

2. Indian API Manufacturers and Exporters

India has cultivated a significant position in the global API market, characterized by its focus on high-quality manufacturing, compliance with international standards, and a growing export footprint. Leading Indian API producers include:

• Biotec Pharmacon International Ltd.
• Glenmark Pharmaceuticals
• Micro Labs Ltd.
• Sigma-Aldrich (part of Merck KGaA)

While not all these companies produce clomiphene citrate API specifically, several Indian API exporters have the capacity or partnerships to supply the compound.

3. Other Notable Suppliers

Europe and North America have comparatively limited API manufacturing for clomiphene citrate due to higher production costs and regulatory barriers. Nonetheless, some specialty chemical firms and contract manufacturing organizations (CMOs) in these regions may produce or synthesize the API under strict quality control measures for niche markets or clinical research.

---

API Quality Standards and Regulatory Considerations

Ensuring API quality aligns with industry standards, such as Pharmacopoeias (USP, EP, BP), and compliance with GMP is critical. For regulatory approval in major markets like the United States (FDA), European Union (EMA), or Japan (PMDA), API manufacturers must provide comprehensive documentation, including:

• Certificate of Analysis (CoA)
• Batch Records and Traceability
• Stability Data
• Certificates of Good Manufacturing Practice (GMP) Compliance

Many leading Chinese and Indian suppliers have achieved certifications conforming to these standards, facilitating easier market access.

---

Key Parameters for Selecting API Suppliers

• Regulatory Compliance: GMP certifications, ISO standards
• Quality Consistency: Batch-to-batch uniformity, purity (>98%)
• Supply Capacity: Ability to meet demand fluctuations
• Pricing Structures: Cost competitiveness balanced with quality
• Supply Chain Reliability: Proven on-time delivery history
• Reputation and Customer Feedback

---

Market Trends and Future Outlook

The API supply landscape for clomiphene citrate is evolving. Increasing regulatory scrutiny, especially from agencies like the US FDA and EMA, emphasizes quality assurance, prompting manufacturers to upgrade facilities and adopt stringent standards. The rising demand for reproductive health products, driven by social factors and medical advancements, sustains steady API demand.

Moreover, the proliferation of biopharmaceutical products and generics encourages diversification of sources. However, geopolitical considerations, trade policies, and supply chain disruptions—exemplified during the COVID-19 pandemic—highlight the importance of diversified, resilient supply networks for API procurement.

---

Conclusion

Selecting a reliable bulk API source for clomiphene citrate necessitates careful assessment of quality, regulatory status, capacity, and supply chain reliability. Chinese and Indian manufacturers dominate the market, with many achieving compliance with international standards. Businesses must conduct diligent due diligence, including site audits and certification verification, to ensure supply continuity and product integrity. As regulatory landscapes tighten, API suppliers investing in quality and transparency will enjoy sustained market access and competitive advantage.

---

Key Takeaways

• Chinese and Indian API manufacturers are the primary sources for bulk clomiphene citrate, with established manufacturing capabilities and global export presence.
• Quality assurance, including GMP compliance and regulatory certifications, remains paramount in supplier selection.
• Increasing regulatory stringency and market demand drive suppliers to upgrade manufacturing processes, ensuring higher purity and consistent quality.
• Diversification of supply sources reduces risk amid geopolitical and supply chain uncertainties.
• Transparent documentation and direct verification enhance confidence in API quality and supply reliability.

---

FAQs

1. What should I look for when sourcing clomiphene citrate API?
Focus on GMP certification, purity (>98%), batch consistency, supply capacity, and supplier reputation. Ensure documentation such as CoA and compliance certificates are available and verifiable.

2. Are Chinese API manufacturers reliable for clomiphene citrate?
Many Chinese API producers meet international quality standards and possess required certifications. Due diligence, including third-party audits and certification verification, is advisable.

3. How does Indian API production compare to Chinese sources?
Indian manufacturers often emphasize high-quality standards, regulatory compliance, and export certifications, making them competitive for global markets, especially where stringent quality is mandated.

4. What regulatory challenges exist for API sources in this sector?
Regulatory agencies require detailed documentation, GMP adherence, stability data, and traceability. Non-compliance can complicate registration and distribution, demanding rigorous supplier vetting.

5. Is the API sourcing landscape for clomiphene citrate shifting?
Yes, with increased regulatory oversight and market demand, suppliers are investing in facility upgrades, certifications, and quality management systems to stay competitive and compliant.

---

References

[1] U.S. Pharmacopoeia (USP). Clomiphene Citrate Monograph. 2021.
[2] World Health Organization (WHO). Pharmaceutical Prequalification Programme. 2022.
[3] Global Industry Analysts. “API Markets and Supply Chain Dynamics.” April 2023.
[4] Chinese Pharmaceutical Industry Association Report. API Manufacturing Capabilities. 2022.
[5] Indian Drug Manufacturers Association (IDMA). API Industry Overview. 2022.