Bulk Pharmaceutical API Sources for acitretin

Bulk Pharmaceutical API Sources for acitretin

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		5284513
Sigma-Aldrich		44707_SIGMA
MolPort		MolPort-003-925-892
Hangzhou APIChem Technology		AC-4702
NIH Clinical Collection		SAM002589973
ABI Chem		AC1NR4LJ

Bulk Active Pharmaceutical Ingredient (API) Sources for Acitretin

Last updated: July 31, 2025

Introduction

Acitretin is a second-generation oral retinoid primarily prescribed for severe psoriasis and keratinization disorders. Its chemical structure, as a systemic retinoid, modulates keratinocyte differentiation and proliferation, offering therapeutic benefits in dermatology. Due to its complex synthesis and stringent quality requirements, sourcing high-quality bulk APIs like acitretin demands meticulous evaluation of supplier credentials, regulatory compliance, and manufacturing standards.

Global API Manufacturers and Suppliers for Acitretin

1. Established Pharmaceutical Ingredient Manufacturers

A limited number of pharmaceutical manufacturers possess the capacity and quality certifications to produce acitretin at GMP standards suitable for pharmaceutical use. These include:

• Hetero Labs Limited (India): As one of India’s leading bulk API producers, Hetero Labs manufactures acitretin according to international quality standards, with active GMP certification linked to its manufacturing facilities. The company supplies to global markets, including North America, Europe, and Asia.

• Mithra Pharmaceutical (France): Mithra specializes in dermatological APIs, including acitretin, emphasizing rigorous process control and regulatory compliance within the European Union framework. Their APIs are often used by both generic and brand-name dermatology products.

• Jubilant Life Sciences (India): Jubilant offers a comprehensive portfolio of small molecule APIs, including acitretin. Their manufacturing processes adhere to WHO-GMP standards, and they have an extensive export footprint.

• Farcast Pharmaceutical (China): As a Chinese API manufacturer, Farcast supplies acitretin with certifications aligning with international quality standards. Their strategic location allows cost-effective production while maintaining compliance.

• Aurore Life Sciences (India): Known for competitive pricing and extensive API portfolio, Aurore Life Sciences supplies acitretin to various markets, adhering to rigorous quality control protocols.

2. Contract Manufacturing and Custom Synthesis

Numerous CMOs provide tailored synthesis of acitretin for pharmaceutical companies seeking customized formulations or bulk production:

• Fagron (Europe): Offers contract synthesis and bulk API procurement, integrating stringent quality checks compliant with EU-GMP standards.

• Lupin Limited (India): Provides large-scale synthesis with an emphasis on regulatory compliance and supply chain stability for acitretin APIs.

• Pharmacia LLC (Russia): Supplies acitretin under strict quality assurance, primarily to European and Asian markets.

Key Considerations for API Sourcing

Regulatory Compliance and Quality Standards

• GMP Certification: Ensure the supplier maintains Good Manufacturing Practices (GMP) certification from recognized authorities like the FDA, EMA, or WHO.
• Certificate of Analysis (CoA): Confirm detailed CoAs that specify purity (>98%), residual solvents, heavy metals, and other impurities.
• Batch Traceability: Reliable documentation and traceability facilitate regulatory audits and quality assurance.

Supply Stability and Lead Times

• Suppliers with proven manufacturing capacity and inventory management minimize risks of shortages.
• Long-term contractual arrangements can secure preferential pricing and priority access.

Cost and Logistics

• Domestic sourcing within regions like India and China offers cost advantages but requires rigorous compliance verification.
• International shipping logistics, customs clearance, and import tariffs influence overall procurement costs.

Emerging Trends and Alternative Sourcing Strategies

Local Manufacturing and Regulatory Navigators

Some pharmaceutical companies are increasingly leveraging local manufacturing to reduce dependencies on overseas suppliers, ensuring faster regulatory approvals and supply chain resilience.

API Sourcing via API Marketplaces

Platforms like Pharmacompass, CPhI, and Tradewinds facilitate global API sourcing, allowing buyers to compare multiple suppliers based on certifications, pricing, and quality audits.

Vertical Integration

Pharmaceutical companies are increasingly investing in integrated manufacturing pathways—producing acitretin in-house or partnering with CROs/CMPs—to guarantee source integrity and compliance.

Regulatory Landscape and Implications

Regulatory agencies, including the US FDA, EMA, and PMDA Japan, enforce stringent standards for APIs. Sourcing from certified suppliers reduces regulatory hurdles, inspection risks, and delays in drug approval processes.

• US FDA’s Drug Master File (DMF): Suppliers with FDA-inspected facilities and active DMFs are preferred.
• European Union (EMA): EU-based suppliers aligned with EMA specifications often simplify the approval process within European markets.

Conclusion

Acitretin sourcing for pharmaceutical manufacturing hinges on supplier reliability, adherence to regulatory standards, and supply chain robustness. Well-established manufacturers in India, China, and Europe—such as Hetero Labs, Mithra Pharmaceuticals, Jubilant Life Sciences, and Aurore Life Sciences—serve as primary sources for high-quality APIs. Strategic partnerships, verified quality certifications, and clear documentation remain critical for procurement success. As the dermatological API market evolves, manufacturers must remain vigilant regarding regulatory updates and emerging supplier options to mitigate risks and optimize cost-efficiency.

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Key Takeaways

• Validate suppliers’ GMP certifications and regulatory compliance before procurement.
• Consider geographic proximity for logistical advantages, but prioritize quality assurance.
• Engage with reputable API marketplaces and industry networks for reliable supplier insights.
• Opt for suppliers with proven track records and transparent documentation.
• Stay updated on regulatory changes affecting API import/export standards to maintain compliance.

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FAQs

Q1: What are the primary regulatory standards for sourcing acitretin API?
A: GMP certification from authorities like the FDA, EMA, or WHO is essential, along with comprehensive Certificates of Analysis demonstrating high purity levels and low residual impurities.

Q2: Which countries are the main producers of acitretin API?
A: India, China, and European nations such as France (Mithra Pharmaceuticals) lead in acitretin production, with companies like Hetero, Jubilant, and Aurore Life Sciences being prominent among them.

Q3: How can I ensure the quality and authenticity of an acitretin API supplier?
A: Verify their GMP certifications, examine detailed CoAs, review audit reports, and assess their compliance with international standards. Engaging third-party quality audits can further ensure credibility.

Q4: What are the key considerations when negotiating API supply contracts?
A: Focus on pricing, lead times, batch consistency, quality assurance procedures, regulatory documentation, and after-sales support.

Q5: Are there emerging technologies or practices affecting acitretin API sourcing?
A: Yes, trends include digital procurement platforms, integrated supply chain management, and the use of contract manufacturing organizations (CMOs) to ensure flexibility, quality, and regulatory compliance.

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References

1. [1] PharmaCompass. “Global API manufacturers for dermatological drugs,” 2023.
2. [2] U.S. Food and Drug Administration. “Drug Master Files (DMFs),” 2023.
3. [3] European Medicines Agency. “Guidelines on Good Manufacturing Practice,” 2023.
4. [4] MarketIntel Reports. “API sourcing trends in dermatology,” 2022.
5. [5] Indian Pharmaceutical Alliance. “Quality standards in API manufacturing,” 2023.