Bulk Pharmaceutical API Sources for dinoprost tromethamine

Bulk Pharmaceutical API Sources for dinoprost tromethamine

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		P0424_SIGMA
Sigma-Aldrich		P5069_SIGMA
NovoSeek		5282415
MolPort		MolPort-003-939-186
ABI Chem		AC1NR011
AKos Consulting & Solutions		AKOS015920234
Chembase.cn		1031

Bulk Active Pharmaceutical Ingredient (API) Sources for Dinoprost Tromethamine

Last updated: August 5, 2025

Introduction

Dinoprost tromethamine, a synthetic prostaglandin F2α analogue, plays a pivotal role in reproductive management within veterinary medicine and, in certain markets, human obstetrics. Its applications include inducing parturition, controlling postpartum hemorrhage, and managing certain reproductive disorders in animals. As a critical API, sourcing high-quality dinoprost tromethamine at scale is essential for pharmaceutical companies, veterinary product manufacturers, and research institutions. This review consolidates current sources, evaluates supplier credibility, and discusses factors influencing procurement strategies.

Overview of Dinoprost Tromethamine

Dinoprost tromethamine is the synthetic equivalent of naturally occurring prostaglandin F2α. Its chemical name is (Z)-7-[(1R,2E,3S,5S)-5-hydroxy-3-[(3R,4S,5S)-4-hydroxy-3,5-dimethyl-2-cyclopenten-1-yl]cyclopentyl]hept-2-enoic acid. The Tromethamine salt improves stability and solubility, facilitating formulation as injectable solutions.

Therapeutic Context

Primarily used in veterinary medicine, dinoprost tromethamine's indications include:

• Induction of parturition in cattle, horses, and swine
• Treatment for postpartum hemorrhage in livestock
• Management of pyometra in certain species

In some human applications, it remains investigational or limited due to regulatory constraints, emphasizing the importance of sourcing compliant and pharmaceutical-grade APIs.

Global API Manufacturing and Supply Landscape

The API manufacturing sector has undergone significant shifts driven by regulatory standards, regional manufacturing capacities, and supply chain dynamics. Key regions contributing to API production include:

• India: Leading the global API market, particularly with cost-effective manufacturing capabilities. Major pharmaceutical hubs include Hyderabad, Ahmedabad, and Mumbai.
• China: Increasingly significant in API production with an expanding portfolio of chemical manufacturing facilities.
• Europe: Focused on high-quality, regulated manufacturing, primarily through smaller specialized firms and CDMOs (Contract Development and Manufacturing Organizations).
• United States: Limited to certain high-quality, compliant API producers catering to domestic markets and regulated exports.

Regulatory Considerations

Manufacturers and buyers must prioritize suppliers compliant with Good Manufacturing Practices (GMP), ISO certifications, and appropriate regulatory approvals (e.g., FDA, EMA, WHO prequalification). Due diligence ensures product safety, efficacy, and traceability.

Leading Suppliers and Manufacturers

Indian API Manufacturers

1. Sandoz (Novartis Group)
Though primarily in finished dosage forms, Sandoz’s API division supplies various prostaglandins, including dinoprost tromethamine, adhering to international GMP standards. Their high-quality API is sourced globally, including markets in Latin America, Asia, and Africa.

2. Sun Pharmaceutical Industries Ltd.
Sun Pharma invests significantly in API manufacturing, offering prostaglandins as part of their reproductive health portfolio. Their facilities in Gujarat and Maharashtra are WHO-GMP certified.

3. Torrent Pharmaceuticals
Known for a broad portfolio covering reproductive APIs, Torrent maintains GMP-compliant production facilities capable of supplying dinoprost tromethamine at scale.

4. Hikal Ltd.
Specializing in complex chemical APIs, Hikal's manufacturing process aligns with international standards, targeting veterinary and human pharmaceutical markets.

Chinese API Manufacturers

5. Zhejiang Hisun Pharmaceutical Co., Ltd.
This company supplies a variety of APIs, including prostaglandins, with GMP certification. Their manufacturing facilities are compliant with international standards, serving both domestic and export markets.

6. Wuxi Jukang Pharmaceutical Co., Ltd.
With extensive experience in chemical synthesis, they produce stable, high-purity dinoprost tromethamine for API wholesale distribution primarily in Asia.

European and US-Based API Providers

European and US manufacturers tend to focus on high-value, highly regulated APIs. Although fewer in number, these providers offer superior regulatory assurances.

7. Excella GmbH
A European API producer specializing in prostaglandins with strict compliance to EU GMP standards.

8. Merck KGaA
Renowned for high-quality pharmaceuticals, Merck supplies select APIs under stringent regulatory control, including prostaglandin derivatives.

Contract Manufacturing and OEM Options

Multiple large CDMOs offer custom synthesis and contract manufacturing services for dinoprost tromethamine, including:

• Bachem AG: Specializes in peptides and complex APIs, offering custom synthesis with high purity requirements.
• UQUIFA: A solid partner for veterinary APIs, with extensive experience in prostaglandin production.

Supply Chain and Procurement Strategies

Quality Assurance

Vendors must demonstrate compliance with GMP, possess valid certifications, and provide comprehensive batch records and stability data. Lifecycle management, validation documentation, and analytical transparency are essential.

Pricing and Lead Times

Indian and Chinese manufacturers tend to offer competitive prices, but lead times may vary due to production capacity and regulatory approvals. Established relationships and supplier audits mitigate potential supply disruptions.

Regulatory and Export Considerations

Importers must confirm product registration, certificates of analysis (CoA), and compliance with regional regulations such as the US FDA, EMA, or country-specific standards. Transparent documentation streamlines approval and reduces compliance risks.

Emerging Trends and Challenges

• Regulatory Stringency: Increasing oversight, especially in the US and Europe, emphasizes quality control, making high GMP standards essential.
• Supply Chain Disruptions: Global events, such as pandemics, have impacted production and logistics, prompting diversification of supplier bases.
• Price Pressure: Competitive markets, especially from India and China, influence pricing but necessitate rigorous supplier validation.
• Biotech and Synthetic Advances: Developments in biosynthesis and alternative manufacturing processes could alter future sourcing paradigms.

Key Considerations for Buyers

• Confirm GMP compliance and relevant certification.
• Evaluate supplier capacity and quality track record.
• Ensure supply chain transparency and traceability.
• Perform due diligence regarding export permits and regional regulatory requirements.
• Consider strategic partnerships with trusted suppliers to ensure consistent supply.

Conclusion

Sourcing bulk dinoprost tromethamine involves navigating a global landscape populated predominantly by Indian, Chinese, European, and North American manufacturers. Buyers must prioritize quality, regulatory compliance, and supply reliability, balancing cost with assurance of GMP standards. As the demand for veterinary and limited human applications persists, the supplier ecosystem is expected to expand, with innovations in manufacturing and quality assurance playing a pivotal role.

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Key Takeaways

• Indian and Chinese manufacturers dominate global supplies due to cost advantages; European and US suppliers focus on high-regulatory markets.
• Regulatory compliance, especially GMP certification, is non-negotiable for safe and effective API procurement.
• Diversifying supplier sources mitigates risks associated with supply chain disruptions.
• Engaging with reputable CDMOs offers custom synthesis options aligned with specific formulation needs.
• Vigilant quality assurance and extensive due diligence streamline regulatory approvals and ensure product integrity.

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Frequently Asked Questions (FAQs)

1. What are the primary regions producing bulk dinoprost tromethamine?
The main production regions are India, China, Europe, and North America, with India and China being dominant due to cost-effective manufacturing capacities.

2. How important is GMP certification when sourcing dinoprost tromethamine?
GMP certification is critical, ensuring the API meets safety, quality, and efficacy standards required by regulatory agencies worldwide.

3. Can I source dinoprost tromethamine directly from manufacturers or only through distributors?
Large-scale buyers and companies with established regulatory compliance can procure directly from manufacturers; smaller entities often utilize authorized distributors or trading partners.

4. Are there any risks associated with sourcing from Chinese or Indian suppliers?
Risks include variability in quality, regulatory compliance, and supply chain stability; rigorous supplier audits and validation help mitigate these issues.

5. What is the typical lead time for bulk API orders?
Lead times vary from 4 to 12 weeks depending on supplier location, order quantity, certification, and regulatory clearance processes.

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References
[1] WHO Prequalification of Medicines Programme, 2022.