Suppliers and packagers for generic pharmaceutical drug: PRALIDOXIME CHLORIDE

PRALIDOXIME CHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare Corp	PROTOPAM CHLORIDE	pralidoxime chloride	INJECTABLE;INJECTION	014134	NDA	Baxter Healthcare Corporation	60977-141-01	6 VIAL, SINGLE-DOSE in 1 PACKAGE (60977-141-01) / 20 mL in 1 VIAL, SINGLE-DOSE (60977-141-27)	1965-03-10

Suppliers for the Pharmaceutical Drug: Pralidoxime Chloride

Last updated: July 29, 2025

Introduction

Pralidoxime chloride, marketed under various brand names, is a critical antidote for organophosphate poisoning—an urgent medical condition caused by exposure to pesticides, nerve agents, or other organophosphates. Its prompt and reliable availability directly impacts patient outcomes and emergency preparedness. This article provides an authoritative overview of global suppliers, investigating manufacturing sources, regulatory considerations, and supply chain dynamics to aid healthcare companies, government agencies, and stakeholders in securing a robust supply of pralidoxime chloride.

Overview of Pralidoxime Chloride

Pralidoxime chloride (2-PAM Cl) acts as a nucleophilic agent that reactivates acetylcholinesterase inhibited by organophosphates. Its efficacy in decontamination protocols makes it indispensable in both hospital and field settings. The drug is typically supplied as an injectable solution, with manufacturing standards governed by global regulatory agencies such as the FDA, EMA, and WHO. As a specialized pharmaceutical, sourcing credible suppliers ensures product quality, regulatory compliance, and consistent availability.

Key Global Suppliers and Manufacturers

1. Commercial Pharmaceutical Companies

Several multinational pharmaceutical companies manufacture pralidoxime chloride, either as a branded product or as a generic. These companies often operate under stringent regulatory oversight and maintain supply chains across continents.

• Pfizer Inc.
  Historically, Pfizer has been a prominent provider of pralidoxime chloride formulations, particularly under the brand name Protopam. Their manufacturing facilities adhere to cGMP standards, ensuring high-quality products for both domestic and international distribution.

• Rhône-Poulenc / Sanofi
  A leading supplier historically involved in the development and manufacturing of pralidoxime formulations. Sanofi, its successor, continues to supply and distribute pralidoxime chloride in multiple territories, adhering to rigorous quality standards.

• Biochem Pharmaceutical Industries, Egypt
  As a regional manufacturer, Biochem supplies pralidoxime chloride in the Middle Eastern and African markets. Their facilities comply with local GMP standards, and their products are often utilized in military and civilian medical applications.

• Himalaya Drug Company (India)
  An emerging manufacturer known for their injectable formulations, including pralidoxime chloride. Their facilities meet local regulatory standards, with increasing exports to South Asian and African markets.

• Cipla Ltd. (India)
  Cipla produces a range of emergency antidote injections, including pralidoxime chloride, with exports to multiple regions and compliance with international pharmacopoeias.

2. Generics and Regional Manufacturers

Further vendors supply pralidoxime chloride as generics, often at lower costs but with similar efficacy, provided they meet quality standards:

• Hetero Labs Ltd. (India)
  A key producer of injectable medications, Hetero supplies pralidoxime chloride that meets local and WHO standards, primarily distributed within the Asian market.

• Sandoz / Novartis
  As part of Novartis, Sandoz is involved in producing generic injectable formulations, including pralidoxime chloride, with global distribution networks.

• Shanxi Jinming Pharmaceutical Co., Ltd. (China)
  A Chinese manufacturer supplying pralidoxime chloride, mostly to regional markets, with increasing efforts to meet international certification standards.

3. Contract Manufacturers and OEM Suppliers

In some instances, pharmaceutical companies procure pralidoxime chloride from third-party contract manufacturing organizations (CMOs) that specialize in sterile injectables.

• Hainan Pharma Group
  This Chinese CMO supplies bulk pralidoxime chloride to regional pharma companies, often rebranded under local labels.

• Fujifilm Diosynth Biotechnologies
  Engaged in contract manufacturing for various pharmaceuticals, including niche antidotes like pralidoxime chloride.

Regulatory and Quality Considerations

The criticality of purity, stability, and consistent supply necessitates reliance on suppliers compliant with Good Manufacturing Practices (GMP), and transparency in sourcing raw materials. Regulatory approvals from agencies such as the FDA, EMA, or national authorities are essential markers of supplier credibility. Notably, many suppliers align with the WHO Model List of Essential Medicines, underscoring their compliance and quality commitments.

Regional Supply Dynamics

Supply reliability varies according to regional manufacturing capacity and export restrictions. Countries such as India and China are prominent regional suppliers, leveraging their extensive pharmaceutical industries to meet local demand and export needs. Conversely, European and North American markets largely depend on a handful of established multinational corporations, which maintain stockpiles and logistical redundancies for emergency scenarios.

Emerging Markets and Challenges

In areas with limited access to high-quality pharmaceuticals, local production of pralidoxime chloride often faces challenges related to manufacturing standards, regulatory oversight, and supply chain infrastructure. International aid organizations and WHO initiatives work to bolster local manufacturing capacity and quality assurance programs.

Supply Chain Considerations

Ensuring an unbroken supply of pralidoxime chloride involves surveillance of manufacturing quality, ensuring regulatory approvals, and establishing geopolitical stability. The COVID-19 pandemic highlighted vulnerabilities in pharmaceutical supply chains; similar issues could affect antidote availability, emphasizing the importance of diversifying supplier bases and stockpiling strategic reserves.

Pricing and Market Trends

Generic suppliers offer competitive pricing, increasing accessibility in developing regions. However, regulatory hurdles and the need for cold chain logistics increase operational costs. Market trends show a push toward formulations with improved stability and ease of administration, broadening supplier variants.

Future Outlook

Advances in manufacturing technology, such as continuous process production and improved bioreactor systems, are expected to enhance pralidoxime chloride supply capacity. Additionally, increasing investments by governments and NGOs in emergency preparedness are likely to stimulate further production and stockpiling efforts.

Key Takeaways

• Leading global suppliers include Pfizer, Sanofi, Cipla, and Hetero Labs, predominantly offering GMP-compliant injectable formulations.
• Regional manufacturers, especially in India and China, significantly contribute to global supply, often at lower costs.
• Ensuring supplier regulatory compliance and product quality remains essential for patient safety and effective treatment.
• Supply chain resilience depends on diversification, strategic stockpiles, and collaborative international efforts.
• Staying abreast of technological advances and regulatory changes can help stakeholders secure reliable access to pralidoxime chloride.

FAQs

1. What are the primary regions manufacturing pralidoxime chloride?
India, China, Egypt, and Western markets (Europe and North America) are the main production hubs, with regional variations in supply reliability.

2. How can healthcare providers verify supplier credibility for pralidoxime chloride?
By reviewing regulatory approvals (FDA, EMA, WHO), GMP certifications, and supplier track records in quality assurance and timely delivery.

3. Are there alternative formulations of pralidoxime chloride?
Yes, research is ongoing into pre-filled syringes, multi-dose vials with improved stability, and liposomal formulations to enhance delivery and shelf life.

4. What are the challenges in sourcing pralidoxime chloride in developing countries?
Limited manufacturing infrastructure, regulatory hurdles, high costs, and logistical issues can constrain availability.

5. How does international regulation impact supply chains?
Stringent regulatory standards ensure safety but may delay approval and entry of new suppliers, affecting availability and pricing.

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References

[1] World Health Organization. (2021). Essential medicines list.
[2] U.S. Food and Drug Administration. (2022). Drug Approvals & Databases.
[3] Sanofi. (2020). Product information for Protopam.
[4] Cipla Ltd.. (2022). Product portfolio and regulatory compliance.
[5] Indian Pharmacopoeia Commission. (2021). Guidelines for injectable manufacturing standards.