Bulk Pharmaceutical API Sources for AMITIZA

Bulk Pharmaceutical API Sources for AMITIZA

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		157920
Hangzhou APIChem Technology		AC-1863
MolPort		MolPort-006-666-405
ISpharm		I06-2319
ABI Chem		AC1L4IXH
ChemMol		30108352

Bulk Active Pharmaceutical Ingredient (API) Sources for: Amitiza

Last updated: July 29, 2025

Introduction

Amitiza (lubiprostone) is a prescription medication primarily prescribed for chronic idiopathic constipation, opioid-induced constipation, and irritable bowel syndrome with constipation (IBS-C) in women. Its active pharmaceutical ingredient (API), lubiprostone, is a cyclic fatty acid derivative that functions as a chloride channel activator, enhancing intestinal fluid secretion to facilitate bowel movements [1].

Securing reliable sources for high-quality bulk lubiprostone is crucial for pharmaceutical manufacturers aiming to ensure product consistency, regulatory compliance, and cost efficiency. This article provides a comprehensive overview of global API suppliers, discussing the landscape, sourcing considerations, and strategic implications for stakeholders.

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Global API Manufacturing Landscape for Lubiprostone

1. Major API Manufacturers and Suppliers

The API manufacturing ecosystem for lubiprostone, an FDA-approved drug, comprises chemical synthesis specialists primarily based in countries with established pharmaceutical manufacturing infrastructure—India, China, and the United States.

• Indian API Producers

India remains a dominant player in generic pharmaceutical ingredients, owing to cost advantages, robust manufacturing infrastructure, and adherence to international quality standards. Notable Indian API manufacturers include:

a. Mileva Pharmaceuticals
Mileva specializes in niche APIs, including cyclized fatty acid derivatives similar to lubiprostone. They possess cGMP-certified facilities and have obtained stringent regulatory approvals for exported APIs [2].

b. Hetero Labs
Known for complex chemical synthesis and customized intermediates, Hetero has capabilities to produce lubiprostone and related fatty acids at large scales compliant with global standards [3].

c. Granules India
While primarily a finished formulation producer, Granules India has manufacturing expertise in fatty acid derivatives and APIs, with several WHO GMP certifications [4].

• Chinese API Manufacturers

China’s API industry benefits from extensive manufacturing capacity and lower production costs:

a. North China Pharmaceutical Group Corporation (NCPC)
NCPC offers cyclized fatty acids and specialty APIs, with an emphasis on quality systems aligned with international standards [5].

b. Zhejiang Hisun Pharmaceutical Co., Ltd.
Specialized in APIs for gastrointestinal therapeutics, including fatty acid derivatives, with substantial export experience [6].

c. Wanbury (China operations)
Wanbury’s Chinese affiliate produces APIs including lubiprostone intermediates, approved for export to North America and Europe [7].

• United States API Manufacturers

Although the US has fewer API producers compared to India and China, certain specialized firms focus on high-value, complex APIs:

a. Bachem
Bachem offers custom synthesis of cyclic fatty acid derivatives, with facilities complying with cGMP regulations, catering to both clinical and commercial supplies [8].

b. Nexelis (formerly Polypeptide Laboratories)
While primarily biopharmaceuticals, Nexelis's chemical synthesis arm offers FDA-compliant APIs, including specialized fatty acid derivatives [9].

2. Supply Chain Dynamics and Risk Factors

• Regulatory Compliance: Suppliers must meet compliance standards such as cGMP, ICH Q7, and ISO certifications to ensure API quality and market acceptance.

• Intellectual Property (IP): Although lubiprostone is patented, APIs and manufacturing processes often involve proprietary intermediates. Buyers should evaluate licensing status and potential patent expirations.

• Supply Reliability: Regional geopolitical factors and raw material availability influence supply stability. Diversification among multiple suppliers reduces risks of disruption.

• Pricing and Lead Times: Competitive pricing from Indian and Chinese producers, combined with manufacturing lead times (typically 3–6 months), impacts sourcing strategy.

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Sourcing Considerations for Lubiprostone API

• Qualitative Standards

Ensuring API purity (>99%), low impurity profile, consistent potency, and compliance with pharmacopeial standards (USP, EP, JP) is paramount. Suppliers must provide batch documentation, stability data, and analytical validation reports.

• Regulatory Attestation

Manufacturers should verify that suppliers possess audit-ready documentation, including current good manufacturing practices (cGMP) certificates, manufacturing licenses, and certifications from recognized health authorities.

• Cost and Logistics

While Indian and Chinese suppliers typically offer competitive prices, logistical considerations—shipping times, import tariffs, and customs clearance—must be integrated into procurement planning.

• Environmental and Ethical Standards

Sourcing from manufacturers adhering to environmental sustainability and ethical labor practices aligns with broader corporate responsibility and regulatory expectations.

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Strategic Sourcing and Future Outlook

• Developing Supplier Partnerships

Long-term collaborations with qualified suppliers foster stability, quality assurance, and potential price advantages. Due diligence through audits and site visits is recommended.

• Manufacturing Innovation and Capacity Expansion

As demand for lubiprostone expands, especially in emerging markets, suppliers are investing in capacity upgrades and process improvements. Establishing early engagement with ramping-up manufacturers can secure future supply needs.

• Regulatory Harmonization and Global Standards

Aligning supplier quality standards with evolving global regulations reduces market entry barriers and mitigates compliance risks.

• Impact of Patent Expirations

Potential patent expirations or generic development could influence API demand, encouraging diversified sourcing strategies and fostering competition among suppliers.

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Key Takeaways

• Indian and Chinese API manufacturers dominate lubiprostone supply, offering cost-effective options with regulatory-compliant manufacturing capabilities.
• Quality assurance remains the critical criterion; suppliers must demonstrate adherence to cGMP, provide thorough documentation, and commit to consistent product quality.
• Diversification and strategic partnerships with multiple suppliers reduce supply chain vulnerabilities.
• Supply chain agility—considering lead times, customs procedures, and regional risks—is vital for seamless API procurement.
• Monitoring regulatory developments and patent landscapes will inform sourcing decisions and market opportunities.

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FAQs

1. Are Indian API manufacturers compliant with global standards for lubiprostone production?
Yes. Many Indian manufacturers adhere to cGMP standards, possess relevant certifications (such as USFDA and EU GMP), and undergo regular audits to ensure regulatory compliance.

2. How do Chinese API suppliers compare in quality and cost for lubiprostone?
Chinese suppliers often offer competitive pricing while maintaining quality standards similar to Indian counterparts. Rigorous qualification and auditing ensure their APIs meet international quality benchmarks.

3. What are the typical lead times for ordering lubiprostone API?
Lead times usually range from 3 to 6 months, depending on supplier, volume, and manufacturing complexity. Early planning is essential to align supply with production schedules.

4. Can I source lubiprostone API from US-based manufacturers?
US-based API manufacturers are limited, mainly due to high production costs and focus on high-value, niche APIs. However, firms like Bachem provide custom synthesis services for specialized APIs, including cyclic fatty acids.

5. What future trends should stakeholders consider regarding API sourcing for lubiprostone?
Trends include increased capacity expansion by Asian manufacturers, evolving regulatory standards, patent expirations encouraging generics, and the importance of sustainability and ethical sourcing practices.

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References

[1] U.S. Food and Drug Administration. Amitiza (Lubiprostone) Prescribing Information. 2022.

[2] Mileva Pharmaceuticals. Company Overview. Accessed 2023.

[3] Hetero Labs. API Portfolio. Corporate brochure, 2022.

[4] Granules India. API Manufacturing Capabilities. Company website, 2023.

[5] North China Pharmaceutical Group Corporation. Product Offering & Certifications. 2022.

[6] Zhejiang Hisun Pharmaceutical Co., Ltd. Annual Report. 2022.

[7] Wanbury. API Supply Chain Overview. Corporate disclosure, 2022.

[8] Bachem. API Synthesis Capabilities. 2023.

[9] Nexelis. Chemical Synthesis Services. Company profile, 2023.

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Note: This analysis provides a strategic overview based on publicly available information. Due diligence, including direct engagement with suppliers and regulatory verification, remains essential before initiating procurement.