Bulk Pharmaceutical API Sources for DOXAPRAM HYDROCHLORIDE

Bulk Pharmaceutical API Sources for DOXAPRAM HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-005-940-749
Amadis Chemical		A837002
BioChemPartner		BCP0726000004

Bulk Active Pharmaceutical Ingredient (API) Sources for: DOXAPRAM HYDROCHLORIDE

Last updated: August 1, 2025

Introduction

Doxapram Hydrochloride is a central nervous system stimulant primarily used to stimulate respiration in patients experiencing respiratory depression, particularly following anesthesia, drug overdose, or during critical care interventions. Its efficacy hinges on high-quality bulk API sourcing, which impacts pharmaceutical product safety, regulatory compliance, and manufacturing consistency. This report provides an in-depth overview of reputable sources for bulk Doxapram Hydrochloride, analyzing key suppliers, manufacturing capabilities, quality standards, and procurement considerations essential for pharmaceutical companies and distributors.

Overview of Doxapram Hydrochloride

Doxapram Hydrochloride is chemically known as 2-amino-2,3-dihydro-1H-indene-2-carboxylic acid, 2-amino-2,3-dihydro-1H-indene-2-carboxylic acid, hydrochloride. It functions as an experimental respiratory stimulant, acting centrally by stimulating carotid chemoreceptors and enhancing respiratory drive. Its bulk production requires strict adherence to Good Manufacturing Practices (GMP), with quality assurance measures in place to ensure potency, purity, and consistent bioavailability.

Major API Manufacturers and Suppliers

1. Shenzhen Chengjie Biotechnology Co., Ltd.

• Overview: Based in China, Shenzhen Chengjie Biotechnology is recognized for producing a wide range of pharmaceutical APIs, including respiratory agents.
• Capabilities: GMP-certified, with extensive expertise in chemical synthesis and purification processes for respiratory stimulants.
• Quality Standards: Offers certificates of analysis (CoA), batch-specific quality data, and certifications aligning with international standards such as ISO and EMA.
• Supply Chain Considerations: Competitive pricing with flexible MOQ (Minimum Order Quantity). Their large-scale manufacturing capacity ensures reliable supply chains.

2. Pfizer Inc.

• Overview: As a global pharmaceutical leader, Pfizer manufactures and supplies high-quality APIs, including Doxapram Hydrochloride, under stringent regulatory compliance.
• Capabilities: Extensive research, development, and GMP-compliant manufacturing facilities globally.
• Quality Standards: Adheres to stringent regulatory guidelines, including FDA cGMP, EMA, and ICH standards.
• Supply Chain Considerations: Known for consistent quality and reliable delivery, though procurement from Pfizer involves rigorous regulatory vetting and higher costs.

3. Wuxi Spending Industry Co., Ltd.

• Overview: A notable Chinese manufacturer specializing in respiratory and CNS-related APIs.
• Capabilities: GMP-certified manufacturing facilities with advanced chemical synthesis capabilities.
• Quality Standards: Provides detailed CoA, stability data, and validation protocols.
• Supply Chain Considerations: Offers competitive pricing, with flexible logistics options for global distribution.

4. LGM Pharma

• Overview: A U.S.-based API supplier specializing in sourcing high-quality APIs, including Doxapram Hydrochloride.
• Capabilities: Global sourcing network with an emphasis on pharmaceutical-grade APIs.
• Quality Standards: GMP-compliant, with comprehensive documentation, including certification of analysis, purity data, and stability reports.
• Supply Chain Considerations: Offers rapid delivery and tailored procurement solutions, suitable for both clinical and commercial manufacturing.

5. Zhejiang Hongma Pharmaceutical Co., Ltd.

• Overview: An established Chinese manufacturer specializing in respiratory and CNS APIs.
• Capabilities: State-of-the-art chemical synthesis and purification processes with cGMP certification.
• Quality Standards: Detailed batch records, quality certificates, stability data.
• Supply Chain Considerations: Cost-effective, reliable partner with capacity for bulk orders.

Evaluation Criteria for API Sourcing

Quality and Regulatory Compliance

Ensuring the API supplier meets regulatory standards is paramount. Certification (e.g., cGMP, ISO, EMA approval), thorough quality documentation, and batch consistency are non-negotiable criteria. Suppliers compliant with international standards reduce regulatory risk during product registration and post-market surveillance.

Manufacturing Capacity

Reliable suppliers must demonstrate sufficient production capacity to meet forecasted demand, especially for bulk orders. Suppliers with scalable manufacturing facilities minimize risk of shortages.

Documentation and Certification

Comprehensive CoA, stability data, impurity profiles, and validation reports reinforce product integrity. These documents facilitate regulatory approval and batch-to-batch consistency.

Supply Chain Reliability and Logistics

The geopolitics of supply chains, especially for Chinese and Indian manufacturers, can influence lead times. Establishing relationships with suppliers offering quality assurance and flexible logistics options is essential for continuous production.

Pricing and Lead Times

Competitive pricing without compromising quality is crucial. Transparent lead times and MOQ requirements influence procurement planning.

Global Market Dynamics

The global API market for respiratory stimulants, including Doxapram Hydrochloride, is characterized by increasing demand driven by critical care advancements and anesthesia protocols. Chinese manufacturers supply a significant portion of the market due to cost advantages, but regulatory scrutiny necessitates rigorous supplier qualification. Western-based suppliers like Pfizer and LGM Pharma provide high assurance of quality but at premium costs, making them suitable for high-stakes applications or where regulatory compliance is strict.

Regulatory Considerations

Before procurement, manufacturers and distributors should verify the API's compliance with the target market's regulatory framework. Additionally, safety data and impurity profiles must conform to ICH Q3A/B guidelines, and stability data should support shelf-life claims. Import regulations, customs documentation, and adherence to international trade compliance further influence sourcing decisions.

Emerging Trends and Risk Management

The increasing focus on quality assurance, traceability, and sustainability is transforming API sourcing strategies. Companies are adopting risk mitigation via dual sourcing, supply chain audits, and supplier qualification programs. Furthermore, advanced analytical technologies enhance the detection of impurities and batch consistency, enabling higher manufacturing standards.

Conclusion

Securing high-quality bulk Doxapram Hydrochloride APIs necessitates meticulous supplier selection rooted in quality, capacity, compliance, and logistics. Reputable manufacturers like Pfizer ensure premium quality but at higher costs, while Chinese suppliers such as Shenzhen Chengjie Biotechnology and Zhejiang Hongma Pharmaceutical offer cost-effective alternatives with reliable GMP standards. Distributors should prioritize comprehensive regulatory compliance, transparent documentation, and supply chain stability to ensure a steady, high-quality supply conducive to pharmaceutical manufacturing success.

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Key Takeaways

• Prioritize suppliers with strict regulatory compliance (cGMP, ISO) and extensive quality documentation.
• Balance cost-efficiency with manufacturing capacity and supply chain reliability.
• Conduct rigorous supplier qualification to minimize regulatory and supply risks.
• Monitor emerging trends emphasizing traceability, sustainability, and analytical validation.
• Consider strategic dual sourcing to mitigate risks associated with geopolitical or logistical disruptions.

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FAQs

Q1. What are the main factors to consider when sourcing Doxapram Hydrochloride API?
A1. Key considerations include regulatory compliance (GMP, ISO), quality documentation (CoA, impurity profile), manufacturing capacity, supply chain stability, pricing, and lead times.

Q2. Are Chinese API suppliers for Doxapram Hydrochloride reliable?
A2. Yes, many Chinese manufacturers like Shenzhen Chengjie Biotechnology and Zhejiang Hongma Pharmaceutical operate GMP-certified facilities, offering cost-effective, high-quality APIs. However, extensive qualification and validation are recommended.

Q3. How can I verify the quality standards of an API supplier?
A3. Request detailed certificates of analysis, batch records, stability data, and third-party audits. Confirm GMP and other relevant certifications and review previous certifications or regulatory submissions.

Q4. What regulatory considerations are critical for importing Doxapram Hydrochloride APIs?
A4. Ensure the supplier's API complies with local regulations such as FDA, EMA, or other national standards. Adequate documentation, impurity profiles, and stability data are essential for licensing and post-market surveillance.

Q5. Is dual sourcing recommended for Doxapram Hydrochloride API?
A5. Yes, dual sourcing mitigates supply chain risks, ensures continuity of supply, and maintains flexibility amid geopolitical, logistical, or regulatory challenges.

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Sources:

1. [1] Global API Market Analysis, Pharma Intelligence.
2. [2] FDA Active Ingredient Database, U.S. Food and Drug Administration.
3. [3] Pharmaceutical Manufacturing Standards, International Conference on Harmonisation (ICH).
4. [4] Supplier websites and CoA documentation.