Bulk Pharmaceutical API Sources for IMIPRAMINE PAMOATE

Bulk Pharmaceutical API Sources for IMIPRAMINE PAMOATE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		24904
ABI Chem		AC1L2NRC
Clearsynth		CS-P-06966
Smolecule		S597302
THE BioTek		bt-372134
Yick-Vic Chemicals & Pharmaceuticals (HK) Ltd.		PH-1917CE
BOC Sciences		10075-24-8

Bulk Active Pharmaceutical Ingredient (API) Sources for Imipramine Pamoate

Last updated: July 30, 2025

Introduction

Imipramine pamoate is a tricyclic antidepressant primarily used to treat depression and enuresis in children. As a complex compound, it is synthesized and supplied as a bulk Active Pharmaceutical Ingredient (API) for pharmaceutical manufacturing. Securing reliable API sources is pivotal for pharmaceutical companies to maintain supply chain integrity, comply with regulatory standards, and ensure product quality. This article offers a comprehensive review of bulk API sources for imipramine pamoate, emphasizing supplier credibility, regulatory considerations, and sourcing strategies.

Chemical Profile of Imipramine Pamoate

Imipramine pamoate is a salt form of imipramine, comprising the tricyclic antidepressant molecule bound to pamoic acid. Its chemical formula is C₂₇H₃₀N₂O₃, and it is characterized by its high lipophilicity, enabling effective central nervous system penetration. The synthesis involves multi-step processes, often requiring specialized chemical expertise and quality control to meet pharmaceutical standards.

Global API Supply Landscape

The API supply chain for imipramine pamoate features key regions, primarily China, India, and Western countries such as the United States and Europe. The reliance on manufacturing hubs in Asia is driven by cost advantages, advanced chemical manufacturing capabilities, and a high volume of generic pharmaceutical production. However, the selection of API suppliers must prioritize regulatory compliance, quality assurance, and stability of supply.

Major API Manufacturers and Suppliers

1. Chinese API Manufacturers

China is a dominant player in the global API market. Several Chinese pharmaceutical and chemical companies offer imipramine pamoate APIs, supported by extensive manufacturing facilities that adhere to Good Manufacturing Practice (GMP) standards.

• Zhejiang Hisun Pharmaceutical Co., Ltd.: Known for a broad API portfolio, including antidepressants, with strict compliance to international quality standards.
• North China Pharmaceutical Group Corporation (NCPC): Offers APIs with validated GMP compliance, emphasizing quality control.
• Shandong Xinhua Pharmaceutical Company: Provides APIs for various psychotropic medications, including imipramine pamoate, with competitive pricing.

2. Indian API Manufacturers

India hosts numerous API producers, with a focus on generic APIs for antidepressants. Many manufacturers possess WHO-GMP and EDQM certifications, making their products suitable for export to regulated markets.

• Cipla Limited: Offers a range of psychotropic APIs, with a commitment to quality and regulatory compliance.
• Sun Pharmaceutical Industries Ltd.: Maintains a robust API manufacturing division, including psychiatric medication APIs.
• Lupin Limited: Supplies APIs with validated quality standards, serving global clients.

3. Western and US/EU API Manufacturers

While fewer in number, some established Western companies produce high-quality APIs for regulated markets, primarily focusing on custom synthesis and large-scale production.

• Piramal Pharma Solutions: Offers comprehensive API manufacturing, including psychotropic compounds, with extensive regulatory documentation.
• BASF Corporation: Known for specialty chemicals, BASF also supplies APIs with stringent quality standards.
• Carbogen Amcis: Specializes in custom and contract manufacturing of active ingredients, including APIs for CNS disorders.

Sourcing Strategies and Considerations

Regulatory Compliance and Certification

Selecting an API supplier requires verification of quality certifications such as GMP, ISO, and EDQM certification. For markets like the US and EU, suppliers must demonstrate adherence to stringent regulatory requirements to ensure API suitability.

Quality Assurance and Testing

Quality standards involve impurity profiling, residual solvent analysis, and stability data. Suppliers providing Certificates of Analysis (CoA) and batch-specific data are preferable. Contractual agreements should also specify quality specifications aligned with pharmacopeial standards (USP, EP, JP).

Supply Chain Stability

Reliability depends on supplier capacity, production volumes, and logistical efficiency. Companies should evaluate the supplier's production throughput, contingency planning, and geopolitical considerations impacting supply continuity.

Pricing and Lead Times

While cost efficiency is essential, oversimplified cost considerations neglect the importance of quality and regulatory compliance. Establishing long-term partnerships with reputable manufacturers can optimize lead times and procurement costs.

Emerging Trends in API Sourcing for Imipramine Pamoate

Recent trends involve increased outsourcing to Contract Manufacturing Organizations (CMOs) specializing in complex APIs. This allows pharmaceutical firms to mitigate risks associated with manufacturing capacity and compliance. Additionally, efforts toward sourcing from manufacturers with transparent quality management systems help mitigate regulatory risks.

Regulatory and Compliance Landscape

Imipramine pamoate API suppliers must adhere to global regulatory standards, including those set by the FDA, EMA, and other regional authorities. Compliance assurance is critical considering the API's psychotropic nature, which subjects it to transport and handling restrictions.

Pharmaceutical companies must conduct rigorous supplier audits, review documented certificates, and perform in-house quality assessments to validate API quality and safety.

Challenges in Sourcing Imipramine Pamoate API

• Limited Manufacturing Capacity: Due to complex synthesis and demand fluctuations.
• Regulatory Barriers: Ensuring compliance across different jurisdictions can be resource-intensive.
• Price Volatility: Sensitive to raw material costs, geopolitical shifts, and environmental regulations.
• Intellectual Property: Navigating patent landscapes, particularly if newer formulations or salt forms are involved.

Conclusion

Sourcing bulk API for imipramine pamoate necessitates a strategic approach emphasizing quality, compliance, and supply stability. Chinese and Indian manufacturers dominate the supply landscape, offering competitive pricing and robust quality systems. However, for products destined for highly regulated markets, collaboration with certified Western API suppliers or qualified CMOs is crucial.

Building long-term relationships with reputable API manufacturers—supported by rigorous qualification, audit, and quality assurance processes—will ensure consistent supply, regulatory compliance, and ultimately, successful pharmaceutical manufacturing.

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Key Takeaways

• The primary sources for imipramine pamoate API are China and India, with increasing quality and regulatory compliance standards.
• Suppliers must possess GMP, ISO, or EDQM certifications, especially for markets with strict regulatory scrutiny.
• Establishing strong supply agreements and conducting thorough quality audits minimize risks associated with API sourcing.
• Contract Research Organizations (CROs) and CMOs are increasingly vital in complex API manufacturing, offering flexibility and risk mitigation.
• Regulatory adherence and quality assurance are the foundation of reliable API procurement, preventing compliance issues and manufacturing delays.

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Frequently Asked Questions (FAQs)

1. What are the key factors to consider when sourcing imipramine pamoate API?
Prioritize regulatory compliance (GMP certification), product quality (impurity profiling, stability), supply chain reliability, and cost efficiency when selecting an API supplier.

2. Are Chinese API manufacturers suitable for regulated market supply?
Yes, many Chinese API producers meet international GMP standards and possess certifications like ISO and EDQM. Companies must verify each supplier’s compliance status and conduct audits.

3. How does quality certification impact API sourcing decisions?
Certifications such as GMP, ISO, and EDQM indicate adherence to quality standards, reducing regulatory risk and ensuring API safety and efficacy.

4. What challenges are associated with sourcing imipramine pamoate API?
Limited manufacturing capacity, regulatory complexities, price fluctuations, and quality assurance are primary challenges in API sourcing.

5. Can toxicity or impurities influence API supplier selection?
Absolutely. Suppliers must provide comprehensive impurity and residual solvent profiles, and products should comply with pharmacopeial standards to mitigate safety concerns.

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Sources:

[1] U.S. Pharmacopeia, "Imipramine Pamoate." U.S. Pharmacopeial Convention, 2022.
[2] European Pharmacopoeia, "API Quality Standards." EDQM, 2023.
[3] Global APIs Market Report, IQVIA, 2022.
[4] PharmaCompass, "Top API Manufacturers for Psychotropics," 2023.
[5] World Health Organization, "WHO List of Certified API Manufacturers," 2021.