PROCAINAMIDE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Caplin	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	INJECTABLE;INJECTION	218674	ANDA	Caplin Steriles Limited	65145-155-10	10 VIAL, MULTI-DOSE in 1 CARTON (65145-155-10) / 10 mL in 1 VIAL, MULTI-DOSE (65145-155-01)	2025-02-17
Caplin	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	INJECTABLE;INJECTION	218674	ANDA	Caplin Steriles Limited	65145-156-10	10 VIAL, MULTI-DOSE in 1 CARTON (65145-156-10) / 2 mL in 1 VIAL, MULTI-DOSE (65145-156-01)	2025-02-17
Gland	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	INJECTABLE;INJECTION	218135	ANDA	Sagent Pharmaceuticals	25021-322-10	10 VIAL in 1 CARTON (25021-322-10) / 10 mL in 1 VIAL	2025-01-15
Gland	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	INJECTABLE;INJECTION	218135	ANDA	Sagent Pharmaceuticals	25021-323-02	10 VIAL in 1 CARTON (25021-323-02) / 2 mL in 1 VIAL	2025-01-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Procaainamide Hydrochloride is a synthetic antiarrhythmic agent used extensively in managing cardiac arrhythmias, particularly ventricular and atrial arrhythmias. Due to its critical role in cardiovascular therapy, a reliable supply chain of high-quality Procaainamide Hydrochloride is essential for pharmaceutical companies, healthcare providers, and research institutions. This article provides a comprehensive overview of the leading suppliers, sourcing considerations, and industry dynamics surrounding Procaainamide Hydrochloride.

Overview of Procaainamide Hydrochloride

Procaainamide Hydrochloride is the hydrochloride salt of procaineamide, a derivative of procainamide. It functions primarily by blocking sodium channels in cardiac cells, thereby stabilizing cardiac electrical activity. The drug is available in various formulations, primarily as injectable solutions and compounding-grade powders.

The global demand for Procaainamide Hydrochloride remains steady due to its longstanding clinical utility. However, manufacturing and supply dynamics are shifting due to tightening regulations, supply chain disruptions, and emerging generic manufacturers.

Key Attributes of Suppliers

Suppliers of Procaainamide Hydrochloride must meet strict pharmaceutical standards, including Good Manufacturing Practices (GMP), rigorous quality control, and compliance with regulatory agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and equivalent authorities worldwide.

Reliability, manufacturing capacity, product purity, and regulatory compliance are critical factors in evaluating suppliers.

Leading Suppliers in the Market

1. Spectrum Chemical Manufacturing Corp.

Overview:
Spectrum is a global distributor of fine chemicals, including active pharmaceutical ingredients (APIs). They supply pharmaceutical-grade Procaainamide Hydrochloride suitable for research and compounding purposes.

Strengths:

Extensive product catalog and regulatory compliance
Stock availability and worldwide distribution network
Suitable for compounding pharmacies and research use

Limitations:

May not cater to large-scale pharmaceutical manufacturing unless explicitly specified as pharmaceutical grade

2. Pharbstar (a division of Apotex Inc.)

Overview:
Pharbstar specializes in generic APIs and has a growing portfolio of cardiovascular active ingredients, including Procaainamide Hydrochloride. Based in Canada, Pharbstar adheres strictly to GMP standards.

Strengths:

High-quality pharmaceutical-grade APIs
Strong regulatory track record
Export capabilities across North America, Europe, and Asia

Limitations:

Price points may vary depending on market conditions

3. Glaxosmithkline (GSK)

Overview:
While primarily a pharmaceutical company, GSK supplies certain high-quality APIs through its global manufacturing network. It may offer Procaainamide Hydrochloride under its API supply chain, often for large-scale manufacturing.

Strengths:

Proven quality and regulatory compliance
Established global distribution channels

Limitations:

Access may be limited to large-volume buyers and OEM agreements

4. Boehringer Ingelheim

Overview:
This German pharmaceutical giant supplies various cardiovascular APIs, including Procaainamide Hydrochloride, primarily targeted at institutional and manufacturing clients.

Strengths:

Stringent manufacturing standards
Extensive experience in cardiovascular drugs

Limitations:

Typically focused on large orders; smaller orders may require negotiation

5. Sandoz (a Novartis division)

Overview:
Sandoz is renowned for its generic pharmaceuticals and APIs. Their portfolio includes active ingredients like Procaainamide Hydrochloride, primarily targeting large-scale pharmaceutical producers.

Strengths:

Competitive pricing and high GMP standards
Established global presence

Limitations:

Availability may be limited to licensed customers with approved supply agreements

6. Local and Regional API Manufacturers

Many countries host regional API manufacturers that produce Procaainamide Hydrochloride conforming to GMP standards. India, China, and eastern Europe are prominent hotspots.

Examples include:

Zhejiang Hisun Pharmaceutical Co., Ltd (China)
Hetero Labs Limited (India)
Synthesis (Europe)

Advantages:

Cost-effective options
Flexibility in supply quantities

Challenges:

Regulatory acceptability varies; quality assurance is essential before procurement

Manufacturing and Quality Considerations

Suppliers of Procaainamide Hydrochloride must confirm adherence to current Good Manufacturing Practice (cGMP) standards. Product purity, stability, and consistent batch-to-batch quality are paramount. Independent third-party testing or certification by recognized authorities bolster supplier credibility.

Regulatory documentation such as Certificates of Analysis (CoA), Certificates of Suitability (CEP), and Drug Master Files (DMF) are crucial for procurement decisions, especially for commercial pharmaceutical manufacturing.

Supply Chain Challenges and Market Dynamics

Despite a relatively mature market, supply chain disruptions have affected API availability across segments, driven by geopolitical factors, raw material shortages, and manufacturing capacity constraints. The COVID-19 pandemic exacerbated these issues, highlighting the necessity for diversified sourcing strategies.

Regulatory hurdles can also impact supply continuity, especially as authorities tighten controls over API manufacturing and importation.

Emerging biosimilar and generic players are increasing competition, often offering more competitive pricing and improved supply reliability.

Strategic Sourcing and Procurement Tips

Verify Regulatory Compliance: Ensure suppliers possess current GMP certifications and relevant registration, such as FDA or EMA approvals.
Request Detailed Documentation: CoA, stability data, and certifications are essential for quality assurance.
Assess Supply Chain Stability: Diversify suppliers regionally to minimize risk.
Evaluate Pricing and Lead Times: Balance cost considerations with quality and reliability.
Engage with Distributors and Contract Manufacturers: Leverage established networks for better procurement terms.

Key Takeaways

Multiple suppliers — from global pharmaceutical companies to regional API manufacturers — provide Procaainamide Hydrochloride, offering varied quality and pricing options.
Quality assurance remains critical; suppliers must adhere to cGMP standards and demonstrate regulatory compliance.
Supply chain resilience is essential amid recent disruptions; diversifying sources minimizes risk.
Regulatory documentation and certifications facilitate procurement and compliance.
Emerging manufacturers are expanding the global supply pool, often at competitive prices, but due diligence is necessary.

Frequently Asked Questions (FAQs)

1. How can I verify the quality of Procaainamide Hydrochloride from a supplier?
Ensure the supplier provides comprehensive documentation, including Certificates of Analysis, Certificates of Compliance, and third-party testing reports. Confirm GMP adherence and regulatory registrations.

2. What are typical lead times for procurement of Procaainamide Hydrochloride?
Lead times vary by supplier and order volume, generally ranging from 4 to 12 weeks. Early engagement with suppliers and establishing long-term agreements can help secure timely delivery.

3. Are there regional differences in suppliers for Procaainamide Hydrochloride?
Yes. While North America and Europe host large pharmaceutical suppliers, Asia—particularly China and India—has numerous regional API producers offering cost-effective options.

4. What regulatory considerations are involved when sourcing Procaainamide Hydrochloride?
Procurement must consider compliance with regulatory authorities such as FDA, EMA, PMDA (Japan), and other regional agencies. Product registration, batch documentation, and stability data are vital.

5. Can compounding pharmacies acquire Procaainamide Hydrochloride directly from suppliers?
Yes, they can source pharmaceutical-grade powders or solutions from chemical suppliers like Spectrum or regional API manufacturers, provided they meet GMP standards and have necessary licenses.

Conclusion

Securing a reliable supply of high-quality Procaainamide Hydrochloride requires understanding the landscape of global and regional suppliers, ensuring compliance with stringent quality standards, and developing resilient sourcing strategies. As the demand for cardiovascular therapeutics persists, robust procurement practices and supplier diversification will remain critical to mitigate risks and ensure continuous patient care.

Sources
[1] International Pharmaceutical Regulators Forum. "API Quality Standards."
[2] European Medicines Agency. "API Manufacturers Directory."
[3] U.S. Food & Drug Administration. "GMP Compliance for Active Pharmaceutical Ingredients."
[4] Pharma Intelligence. "API Market Trends and Supply Chain Dynamics."
[5] Company websites and product catalogs for Spectrum, Pharbstar, GSK, Boehringer Ingelheim, Sandoz.

Suppliers and packagers for generic pharmaceutical drug: PROCAINAMIDE HYDROCHLORIDE