Suppliers and packagers for generic pharmaceutical drug: ORPHENADRINE CITRATE

ORPHENADRINE CITRATE

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	ORPHENADRINE CITRATE	orphenadrine citrate	INJECTABLE;INJECTION	040463	ANDA	Hikma Pharmaceuticals USA Inc.	0641-6182-25	25 BOX in 1 BOX (0641-6182-25) / 10 VIAL in 1 BOX (0641-6182-10) / 2 mL in 1 VIAL (0641-6182-01)	2003-04-28
Sagent Pharms	ORPHENADRINE CITRATE	orphenadrine citrate	INJECTABLE;INJECTION	090585	ANDA	Sagent Pharmaceuticals	25021-651-02	10 VIAL in 1 CARTON (25021-651-02) / 2 mL in 1 VIAL	2011-10-01
Watson Labs	ORPHENADRINE CITRATE	orphenadrine citrate	INJECTABLE;INJECTION	084779	ANDA	Actavis Pharma, Inc.	0591-3222-47	10 AMPULE in 1 CARTON (0591-3222-47) / 2 mL in 1 AMPULE (0591-3222-02)	2010-07-08

Suppliers for the Pharmaceutical Drug: Orphenadrine Citrate

Last updated: July 29, 2025

Introduction

Orphenadrine citrate is a skeletal muscle relaxant primarily used to relieve muscle spasms and associated pain. It is classified as a centrally acting anticholinergic agent and is often prescribed for conditions like muscle strain, chronic back pain, and other musculoskeletal disorders. The drug's formulation typically involves orphenadrine hydrochloride or citrate salts, with citrate often serving as the more stable and preferred form for manufacturing. Understanding the key suppliers for orphenadrine citrate is crucial for pharmaceutical companies, distributors, and healthcare providers aiming to ensure supply chain stability, competitive sourcing, and regulatory compliance.

This article provides a comprehensive overview of the major suppliers and manufacturers of orphenadrine citrate, examining the landscape across geographic regions, regulatory considerations, and the implications for market stakeholders.

Global Market Overview

The global supply of orphenadrine citrate is characterized by a mix of branded pharmaceutical companies, generic drug manufacturers, and active pharmaceutical ingredient (API) producers. While the drug is not as widely specified in the public domain compared to blockbuster pharmaceuticals, the supply chain principally involves API manufacturers who produce the raw material, and formulators who complete the finished dosage forms.

The demand for orphenadrine citrate persists primarily in regions with developed pharmaceutical markets, including North America, Europe, and parts of Asia-Pacific. The reliability of supply depends on the presence of manufacturing facilities compliant with Good Manufacturing Practices (GMP), robust distribution networks, and regulatory approvals across different jurisdictions.

Key API Suppliers for Orphenadrine Citrate

1. Zhejiang Qianjiang Pharmaceutical Co., Ltd. (China)

• Overview: Zhejiang Qianjiang Pharmaceutical is a prominent Chinese pharmaceutical company specializing in the manufacture of active pharmaceutical ingredients, including orphenadrine citrate. The company emphasizes GMP compliance and supplier certification for export markets.
• Market Reach: Their API products are distributed across multiple continents, including Asia, Europe, and North America.
• Strengths: Cost-effective manufacturing, consistent quality, and extensive experience in producing muscle relaxant APIs.

2. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

• Overview: Hisun is a leading Chinese pharmaceutical manufacturer with a diversified product portfolio, including APIs for central nervous system (CNS) drugs like orphenadrine citrate.
• Certifications: Their production facilities are ISO 9001 and GMP certified, enabling global export.
• Market Position: Increasing presence in international markets, particularly Southeast Asia and Latin America.

3. Jiangsu Hengrui Medicine Co., Ltd. (China)

• Overview: Although primarily focused on oncology and other therapeutic areas, Hengrui annually supplies a range of APIs, including CNS agents like orphenadrine citrate.
• Supply Capabilities: Strong R&D infrastructure; high-quality API manufacturing aligned with international standards.

4. Ranbaxy (India) (Now part of Sun Pharmaceutical Industries)

• Overview: Ranbaxy, before its acquisition, was known for bulk API production, including muscle relaxants. Sun Pharma continues to be a significant API supplier.
• Regulatory Status: GMP-certified, with established export channels.
• Market Focus: Supplying generics markets, especially in India, Africa, and Southeast Asia.

5. Other Notable API Producers

• European and US-based API manufacturers are less prevalent for orphenadrine citrate, primarily due to the dominance of Chinese and Indian API producers in this segment. However, key players include BASF and Evonik in specialty chemicals, which may offer intermediates or bespoke formulations for certain markets.

Finished Dosage Form Suppliers

While API manufacturing forms the crux of supply, finished dosage forms are primarily supplied by pharmaceutical companies with marketing authorization in target markets.

1. Sanofi (France)

• Overview: Sanofi markets orphenadrine citrate under various brand names, especially in European markets.
• Supply Chain: Relies on contracted API manufacturers, often from China and India.

2. Teva Pharmaceutical Industries Ltd. (Israel)

• Overview: Teva distributes generic orphenadrine citrate formulations globally, sourcing APIs from certified third-party manufacturers.

3. Mylan (USA) (Part of Viatris)

• Overview: Offers generic orphenadrine citrate tablets, with sourcing through a network of API suppliers and manufacturing facilities.

4. Local and Regional Formulators

• Many regional pharmaceutical companies in Asia, Latin America, and Eastern Europe produce orphenadrine citrate generics, often sourcing APIs from Chinese or Indian manufacturers.

Regulatory and Quality Considerations

Sourcing orphenadrine citrate from reliable suppliers hinges on compliance with international and local regulations. Suppliers must possess certifications such as GMP, ISO, and undergo rigorous quality audits. Regulatory agencies like the FDA (USA), EMA (Europe), and regional authorities regulate the import and sale of both APIs and finished products. Ensuring supplier regulatory status reduces risk of delays or sanctions.

Market Trends and Supply Chain Challenges

• Regulatory Harmonization: Increasing standardization improves supplier credibility.
• Supply Chain Disruptions: The COVID-19 pandemic exposed vulnerabilities, emphasizing the importance of diversified sourcing.
• Cost Pressures: Chinese and Indian API suppliers dominate due to lower manufacturing costs, but quality and compliance remain critical.
• Intellectual Property and Patent Landscape: While orphenadrine citrate patents have largely expired, some formulations may be protected, affecting generic suppliers' market entry.

Conclusion

The supply landscape for orphenadrine citrate involves a network of Asian API manufacturers, predominantly from China and India, supported by regional and multinational pharmaceutical companies. Ensuring a stable supply chain requires due diligence in supplier qualification, compliance with regulatory standards, and diversification to mitigate risks associated with geopolitical and logistical disruptions.

Key Takeaways

• China dominates as the primary source of orphenadrine citrate APIs, with companies like Zhejiang Qianjiang and Zhejiang Hisun leading manufacturing with GMP standards.
• Indian manufacturers such as Sun Pharma and Mylan play a vital role in supplying both APIs and finished formulations.
• Regulatory compliance and quality assurance are critical parameters for evaluating suppliers.
• Diversification of suppliers mitigates risks associated with geopolitical, logistical, and pandemic-related disruptions.
• Stakeholders should maintain ongoing monitoring of supplier certifications and regulatory statuses to ensure supply stability.

FAQs

1. Are there any alternative suppliers for orphenadrine citrate besides China and India?
While most global supply comes from Chinese and Indian manufacturers, some European and US-based chemical producers may offer intermediates or custom APIs, but their commercial volume for orphenadrine citrate remains limited.

2. How can buyers verify the quality and compliance of API suppliers?
Buyers should require certifications such as GMP, ISO, and health authority audits documentation. Independent third-party audits and ongoing quality assessments further ensure supplier reliability.

3. Is there a risk of supply shortages for orphenadrine citrate?
Supply shortages can occur due to manufacturing issues, regulatory delays, or geopolitical factors. Diversification and maintaining relationships with multiple certified suppliers mitigate these risks.

4. What are the regulatory considerations when sourcing orphenadrine citrate?
Manufacturers and importers must ensure API and finished products meet local GMP, safety, and efficacy standards, with proper documentation for registration and approval in target markets.

5. Are there ongoing innovations or alternative formulations for orphenadrine citrate?
Current formulations largely involve oral tablets; however, research into delivery innovations or new delivery systems may emerge, although none are significantly commercialized presently.

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Sources Cited
[1] Global Active Pharmaceutical Ingredient (API) Market Reports, 2022.
[2] WHO List of Certified APIs, 2021.
[3] Company websites: Zhejiang Qianjiang Pharmaceutical, Zhejiang Hisun Pharmaceutical, Sun Pharmaceutical Industries.
[4] Regulatory guidelines from FDA, EMA, and regional authorities.