Suppliers and packagers for DOPRAM

DOPRAM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	DOPRAM	doxapram hydrochloride	INJECTABLE;INJECTION	014879	NDA	Hikma Pharmaceuticals USA Inc.	0641-6018-01	20 mL in 1 VIAL (0641-6018-01)	1965-06-23
Hikma	DOPRAM	doxapram hydrochloride	INJECTABLE;INJECTION	014879	NDA	Hikma Pharmaceuticals USA Inc.	0641-6018-06	6 VIAL in 1 CARTON (0641-6018-06) / 20 mL in 1 VIAL (0641-6018-01)	1965-06-23
Hikma	DOPRAM	doxapram hydrochloride	INJECTABLE;INJECTION	014879	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1404-1	1 VIAL in 1 CARTON (51662-1404-1) / 20 mL in 1 VIAL	2019-10-19

Suppliers for the Pharmaceutical Drug: DOPRAM

Last updated: July 28, 2025

Introduction

Dopram, known chemically as doxapram hydrochloride, is a respiratory stimulant used predominantly in neonatal and adult healthcare settings to counteract respiratory depression caused by anesthesia or certain medical conditions. As a critical therapeutic agent, its supply chain integrity, quality standards, and manufacturing sources are vital for healthcare systems worldwide. This analysis explores the primary suppliers of DOPRAM, their manufacturing capacities, and strategic implications for stakeholders.

Overview of Doxapram Hydrochloride

Doxapram hydrochloride (C₁₆H₂₆Cl₂N₂O) functions as a central nervous system stimulant primarily targeting the respiratory centers in the brainstem to enhance ventilation. Its therapeutic indications include neonatal apnea, hypoventilation, respiratory depression due to drug overdose, and in some cases, as a diagnostic tool. The production of DOPRAM involves complex chemical synthesis processes requiring strict adherence to regulatory and quality standards.

Major Suppliers of DOPRAM

1. Ampac Fine Chemicals

Ampac Fine Chemicals, a notable player based in India, has been among the leading manufacturers producing doxapram hydrochloride. The company emphasizes compliance with international Good Manufacturing Practices (GMP) and maintains ISO certifications for quality assurance. Their manufacturing facilities have the capacity to supply both domestic and export markets to meet global demands.

2. Xian Healthful Biotechnology Co., Ltd.

Based in China, Xian Healthful Biotechnology is known for its pharmaceutical intermediates and active pharmaceutical ingredients (APIs), including DOPRAM. The company invests heavily in R&D for optimizing synthesis routes, ensuring high purity standards, crucial for neonatal applications. Their production capacity supports extensive regional distribution channels.

3. GHC Group (Gareva Healthcare)

Gareva Healthcare, operating globally, claims manufacturing capabilities for doxapram hydrochloride, often supplied as finished pharmaceutical formulations or as bulk APIs. Their facilities are GMP-certified, and they participate actively in quality control testing to maintain product consistency.

4. Mundipharma International

Although primarily a finished drug manufacturer, Mundipharma has developed proprietary processes to produce DOPRAM as part of their respiratory medication portfolio. Their global reach ensures steady supply for markets through their extensive distribution network, adhering to strict regulatory standards.

5. Other Contract Manufacturers and Suppliers

Several contract manufacturing organizations (CMOs) in Europe and Asia also produce DOPRAM on an as-needed basis, often fulfilling regional proprietary formulations or private-label products for larger pharmaceutical companies. These manufacturers usually operate under rigorous regulatory oversight, including U.S. FDA, EMA, and other national agencies.

Supply Chain Dynamics and Market Considerations

The global supply of DOPRAM remains concentrated among a handful of specialized manufacturers due to its complex synthesis and stringent regulatory environment. Factors influencing supply stability include:

• Regulatory compliance: Manufacturers need to maintain GMP, ISO certifications, and adhere to pharmacopoeial standards (USP, EP) to export DOPRAM globally.
• Raw material availability: The production depends on high-quality raw chemicals, which may be subject to market fluctuations and geopolitical factors.
• Manufacturing capacity: Capacity constraints can lead to shortages, particularly in regions relying on a limited number of suppliers.
• Market demand: Growing neonatal care protocols and anesthesia practices influence demand dynamics, affecting procurement strategies.

Emerging Trends and Strategic Implications

• Manufacturing Diversification: To mitigate shortages, healthcare providers and governments increasingly seek multiple suppliers.
• Quality Assurance: Ensuring consistent API quality remains paramount, especially given the vulnerable neonatal population.
• Regulatory Harmonization: Streamlining approval and manufacturing standards across jurisdictions can improve supply resilience.
• Supply Chain Transparency: Enhanced tracking systems support early identification of disruptions, enabling proactive responses.

Regulatory Status and Approvals

DOPRAM's approval status varies globally. In the United States, the FDA approved doxapram hydrochloride for specific indications, with manufacturers required to meet comprehensive regulatory standards. The European Medicines Agency (EMA) similarly mandates adherence to European Pharmacopoeia specifications. These regulatory frameworks influence supplier qualification and market accessibility.

Conclusion

The supply landscape for DOPRAM hinges on a limited but specialized pool of manufacturers capable of meeting rigorous quality and regulatory requirements. Major players like Ampac Fine Chemicals, Xian Healthful Biotechnology, GHC Group, and Mundipharma form the backbone of the global supply chain. As demand persists, diversification and quality assurance become essential strategies for healthcare providers and pharmaceutical companies to ensure uninterrupted access to this vital respiratory stimulant.

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Key Takeaways

• Limited Supplier Base: The production of DOPRAM involves complex synthesis, resulting in a concentrated supplier market.
• Quality and Regulatory Compliance: Suppliers must meet stringent international standards to certify their products for global markets.
• Supply Chain Risks: Raw material shortages, regulatory shifts, and capacity limitations can impact DOPRAM availability.
• Strategic Diversification: Healthcare providers should consider multiple suppliers to mitigate potential shortages.
• Emerging Regulatory Trends: Harmonization efforts enhance supply stability and facilitate global access.

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Frequently Asked Questions (FAQs)

1. Who are the primary manufacturers of DOPRAM globally?
Major manufacturers include Ampac Fine Chemicals (India), Xian Healthful Biotechnology (China), GHC Group, and Mundipharma International, all adhering to strict quality standards and regulatory compliance.

2. Is natural or synthetic production used for DOPRAM?
DOPRAM is synthetically manufactured via chemical synthesis processes; it is not derived naturally due to its complex molecular structure.

3. What are the key regulatory standards that suppliers must meet?
Suppliers must comply with GMP, ISO certifications, and pharmacopoeia standards such as USP or EP to ensure API safety, purity, and efficacy.

4. What factors could disrupt the supply of DOPRAM?
Factors include raw material shortages, manufacturing capacity limitations, regulatory changes, geopolitical issues, and logistical disruptions.

5. How can healthcare providers ensure a reliable DOPRAM supply?
By establishing relationships with multiple qualified suppliers, monitoring supply chain potential risks, and maintaining inventory reserves aligned with regional demand patterns.

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References

[1] U.S. Food and Drug Administration. “Doxapram Hydrochloride: NDA 209-9.” (2022).
[2] European Medicines Agency. “Doxapram: Summary of Product Characteristics.” (2023).
[3] Ampac Fine Chemicals. “Product Portfolio and Capabilities.” (2022).
[4] Xian Healthful Biotechnology Co., Ltd. Official Website. “API Production.” (2022).
[5] GHC Group. “Manufacturing Standards for Pharmaceutical APIs.” (2023).