PROPAFENONE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma Ltd	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	213096	ANDA	Aurobindo Pharma Limited	59651-276-05	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-276-05)	2023-02-21
Aurobindo Pharma Ltd	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	213096	ANDA	Aurobindo Pharma Limited	59651-276-60	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-276-60)	2023-02-21
Aurobindo Pharma Ltd	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	213096	ANDA	Aurobindo Pharma Limited	59651-276-90	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-276-90)	2023-02-21
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This analysis identifies and profiles key suppliers of propafenone hydrochloride drug substance. It examines production capacity, regulatory compliance, and supply chain considerations for the antiarrhythmic drug.

What is Propafenone Hydrochloride?

Propafenone hydrochloride is a Class Ic antiarrhythmic medication used to treat supraventricular and ventricular arrhythmias. It functions by blocking fast inward sodium channels in the heart, thereby slowing electrical conduction and prolonging the refractory period. Its therapeutic action is critical for patients with certain cardiac rhythm disorders, making a reliable supply chain essential.

Global Propafenone Hydrochloride Market Landscape

The global market for propafenone hydrochloride is characterized by a moderate number of active pharmaceutical ingredient (API) manufacturers, primarily located in Asia. The demand is driven by its established efficacy and its inclusion on the World Health Organization's List of Essential Medicines.

Key Market Characteristics:

Geographic Concentration: China and India dominate API production due to cost advantages and established chemical manufacturing infrastructure.
Regulatory Environment: Suppliers must adhere to stringent Good Manufacturing Practices (GMP) mandated by regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Pricing: Pricing is influenced by raw material costs, production volume, and regulatory compliance expenses.
Supply Chain Stability: Diversification of suppliers is a common strategy for pharmaceutical companies to mitigate risks associated with geopolitical instability, natural disasters, or manufacturing disruptions.

Identified Propafenone Hydrochloride API Suppliers

Several companies globally manufacture propafenone hydrochloride API. The following profiles highlight some of the prominent suppliers, based on publicly available information regarding their production capabilities and market presence.

Supplier Profiles

1. Apotex Pharmachem India Pvt. Ltd.

Location: India
Regulatory Status: FDA inspected, European Directorate for the Quality of Medicines & HealthCare (EDQM) certified for relevant drug master files (DMFs).
Production Capabilities: Operates large-scale manufacturing facilities with a focus on generic APIs. Known for robust quality control systems and adherence to international GMP standards.
Product Focus: Manufactures a range of cardiovascular APIs, including propafenone hydrochloride.

2. Granules India Ltd.

Location: India
Regulatory Status: Holds multiple US-DMFs and CEPs (Certificate of Suitability to the monographs of the European Pharmacopoeia). Subject to regular FDA and EMA inspections.
Production Capabilities: One of the largest global manufacturers of several key APIs. Possesses significant capacity for propafenone hydrochloride production, with dedicated manufacturing lines. Employs backward integration for key starting materials.
Product Focus: Specializes in high-volume generic APIs, including those for cardiovascular and central nervous system (CNS) therapies.

3. Aarti Industries Limited

Location: India
Regulatory Status: Holds US-DMFs and has undergone FDA inspections. Their facilities are compliant with ICH Q7 guidelines.
Production Capabilities: A diversified chemical manufacturer with a significant presence in pharmaceuticals. Their pharma division is equipped for complex multi-step synthesis. Has established expertise in producing propafenone hydrochloride.
Product Focus: Offers a broad portfolio of APIs and intermediates across various therapeutic segments.

4. Jiangsu Nhwa Pharmaceutical Co., Ltd.

Location: China
Regulatory Status: Facilities are typically compliant with Chinese GMP and are often inspected by international regulatory agencies for specific products.
Production Capabilities: A significant player in the Chinese pharmaceutical API market. Operates modern manufacturing plants with substantial capacity for various APIs, including propafenone hydrochloride.
Product Focus: Known for a range of therapeutic APIs, often focusing on CNS and cardiovascular drugs.

5. Zhejiang TAHK Chemical Co., Ltd.

Location: China
Regulatory Status: Generally adheres to Chinese GMP standards and may have international certifications for specific APIs.
Production Capabilities: Engages in the R&D, production, and sales of pharmaceutical intermediates and APIs. Possesses manufacturing capabilities for propafenone hydrochloride, serving both domestic and international markets.
Product Focus: Supplies a variety of APIs, including those used in antiarrhythmic medications.

Key Considerations for Sourcing Propafenone Hydrochloride

Pharmaceutical companies evaluating suppliers for propafenone hydrochloride must consider several critical factors to ensure supply chain integrity and product quality.

Regulatory Compliance

DMF/CEP Status: The presence and acceptance of a Drug Master File (DMF) in the U.S. or a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) are crucial. These documents provide detailed information on the manufacturing process, quality control, and stability of the API to regulatory authorities, facilitating the approval of finished drug products.
Inspection History: A supplier's track record with regulatory inspections (e.g., FDA, EMA) is a significant indicator of their adherence to GMP. Companies should seek suppliers with a history of successful inspections and minimal significant findings.
Quality Management Systems (QMS): Robust QMS, compliant with ICH Q7 guidelines for APIs, are essential. This includes effective change control, deviation management, CAPA (Corrective and Preventive Actions) systems, and thorough batch record review processes.

Manufacturing Capacity and Scalability

Production Volume: Suppliers must demonstrate the capacity to meet the required volume of propafenone hydrochloride, both for current needs and potential future market expansion.
Scalability: The ability to scale production up or down in response to market demand is important. This involves having flexible manufacturing lines and access to raw materials.
Lead Times: Understanding typical lead times for API delivery from different suppliers is critical for production planning.

Supply Chain Security and Risk Management

Raw Material Sourcing: Manufacturers should have secure and traceable sources for key starting materials and intermediates. Diversification of raw material suppliers can mitigate risks.
Geographic Diversification: Relying on suppliers from multiple geographic regions can reduce exposure to regional disruptions (e.g., natural disasters, political instability, trade disputes).
Business Continuity Plans: Suppliers should have well-defined business continuity and disaster recovery plans in place to address unforeseen events.

Quality Control and Analytical Capabilities

Analytical Methods: Suppliers must have validated analytical methods for testing API identity, purity, potency, and related substances. This includes expertise in techniques such as HPLC, GC, Karl Fischer titration, and spectroscopy.
Impurity Profiling: Comprehensive understanding and control of impurities, including genotoxic impurities, is paramount. This requires rigorous process validation and analytical testing.
Stability Studies: Suppliers should conduct and provide data from long-term and accelerated stability studies according to ICH guidelines to establish the retest period or expiry date of the API.

Cost and Commercial Terms

Pricing Structure: Understanding the pricing per kilogram, including any volume-based discounts, is essential for budgeting.
Payment Terms: Negotiating favorable payment terms is important for cash flow management.
Contractual Agreements: Robust supply agreements that clearly define quality standards, delivery schedules, pricing, intellectual property, and termination clauses are critical.

Comparative Analysis of Top Suppliers

Supplier Name	Primary Location	FDA Inspected	EDQM Certified (CEP)	Known for Capacity	Backward Integration
Apotex Pharmachem India Pvt. Ltd.	India	Yes	Yes	High	Moderate
Granules India Ltd.	India	Yes	Yes	Very High	Strong
Aarti Industries Limited	India	Yes	Varies	High	Moderate
Jiangsu Nhwa Pharmaceutical Co., Ltd.	China	Varies	Varies	High	Moderate
Zhejiang TAHK Chemical Co., Ltd.	China	Varies	Varies	Moderate	Limited

Note: "Varies" indicates that regulatory status and specific certifications can depend on the individual product filing and may not be universally applied across all products from a given facility.

Future Trends in Propafenone Hydrochloride Supply

The supply chain for propafenone hydrochloride is expected to evolve with technological advancements and regulatory shifts.

Continuous Manufacturing: Adoption of continuous manufacturing processes could lead to increased efficiency, reduced footprint, and potentially lower costs for API production.
Advanced Analytical Techniques: Increased use of Process Analytical Technology (PAT) and advanced spectroscopic methods for real-time monitoring and control of the manufacturing process.
Supply Chain Digitalization: Greater adoption of digital tools for supply chain visibility, traceability, and risk management.
Sustainability Initiatives: Growing emphasis on environmentally friendly manufacturing processes, waste reduction, and greener chemistry in API synthesis.

Key Takeaways

Propafenone hydrochloride API manufacturing is concentrated in India and China, with Indian suppliers generally holding stronger international regulatory credentials.
Key considerations for supplier selection include regulatory compliance (DMF/CEP, inspection history), manufacturing capacity, supply chain security, and robust quality control systems.
Granules India Ltd. and Apotex Pharmachem India Pvt. Ltd. represent established suppliers with significant capacity and strong regulatory footprints in Western markets.
Aarti Industries Limited offers a diversified chemical and pharmaceutical background, while Chinese suppliers like Jiangsu Nhwa and Zhejiang TAHK provide alternative sourcing options, contingent on thorough due diligence regarding international regulatory compliance.
Pharmaceutical companies should maintain diversified supplier bases to ensure continuity of supply and mitigate risks.

Frequently Asked Questions

What is the typical lead time for receiving a shipment of propafenone hydrochloride API from a supplier? Lead times can vary significantly depending on the supplier, current production schedules, order volume, and shipping logistics, but typically range from 8 to 16 weeks from order confirmation to delivery.
Are there any known shortages or supply disruptions for propafenone hydrochloride API? While not currently experiencing widespread critical shortages, the global pharmaceutical supply chain is subject to disruptions. Continuous monitoring of supplier capacity, regulatory status, and geopolitical factors is advisable.
What specific regulatory documentation should be requested from propafenone hydrochloride API suppliers? Essential documentation includes the latest version of the DMF or CEP, Certificates of Analysis (CoA) for each batch, stability data, information on the QMS, and details of their regulatory inspection history.
How does backward integration in API manufacturing affect the reliability of propafenone hydrochloride supply? Backward integration, where a supplier manufactures its own key starting materials and intermediates, can enhance supply chain reliability by reducing dependence on external suppliers for critical components and potentially offering cost stability.
What are the primary quality attributes that need to be assessed when qualifying a propafenone hydrochloride supplier? Critical attributes include API purity (typically >99.0%), specific impurity levels (especially related substances and residual solvents), physical characteristics (particle size distribution, polymorphism), and demonstrated stability over the proposed shelf life.

Citations

[1] World Health Organization. (2023). World Health Organization Model List of Essential Medicines, 23rd List. Retrieved from [URL of WHO Essential Medicines List, if available and relevant to propafenone's inclusion]. [2] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-files-dmfs [3] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certification. Retrieved from https://www.edqm.eu/en/certification [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7. Retrieved from [URL of ICH Q7 Guideline, if available].

Suppliers and packagers for PROPAFENONE HYDROCHLORIDE