You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 12, 2025

Suppliers and packagers for ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE


✉ Email this page to a colleague

« Back to Dashboard


ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Stevens J ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE aspirin; caffeine; orphenadrine citrate TABLET;ORAL 074988 ANDA Jerome Stevens Pharmaceuticals, Inc. 50564-554-01 100 TABLET in 1 BOTTLE (50564-554-01) 1999-04-30
Stevens J ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE aspirin; caffeine; orphenadrine citrate TABLET;ORAL 074988 ANDA Jerome Stevens Pharmaceuticals, Inc. 50564-554-05 500 TABLET in 1 BOTTLE (50564-554-05) 1999-04-30
Stevens J ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE aspirin; caffeine; orphenadrine citrate TABLET;ORAL 074988 ANDA Jerome Stevens Pharmaceuticals, Inc. 50564-555-01 100 TABLET in 1 BOTTLE (50564-555-01) 1999-04-30
Stevens J ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE aspirin; caffeine; orphenadrine citrate TABLET;ORAL 074988 ANDA Jerome Stevens Pharmaceuticals, Inc. 50564-555-05 500 TABLET in 1 BOTTLE (50564-555-05) 1999-04-30
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Last updated: August 3, 2025

ppliers for the Pharmaceutical Drug: Orphenadrine Citrate, Aspirin, and Caffeine

Introduction

The combined pharmaceutical formulation of orphenadrine citrate, aspirin, and caffeine is utilized in the treatment of conditions such as muscle pain, tension headaches, and other musculoskeletal disorders. This combination leverages orphenadrine’s muscle relaxant properties, aspirin’s anti-inflammatory and analgesic effects, and caffeine’s central nervous system stimulant to enhance analgesic efficacy. Analyzing the supply landscape of these components reveals the key players involved in sourcing, manufacturing, and distributing these substances globally.

Manufacturers of Individual Components

Orphenadrine Citrate

Orphenadrine citrate is a synthetic drug primarily manufactured in India, China, and Europe. Leading pharmaceutical companies produce bulk active pharmaceutical ingredients (APIs), with some notable suppliers listed below.

  • Taj Pharmaceuticals Ltd. (India)
    As one of India's prominent API manufacturers, Taj Pharmaceuticals supplies orphenadrine citrate to both domestic and international markets. Their facilities adhere to WHO-GMP standards, enabling export to regulated markets.

  • Zhejiang Huadong Pharmaceutical Co. Ltd. (China)
    A major Chinese API manufacturer, Huadong supplies orphenadrine citrate, among other central nervous system agents, catering to global pharmaceutical firms.

  • Campus Pharma (India)
    Specializing in a wide range of CNS-related APIs, Campus Pharma produces orphenadrine citrate for generic drug applications.

Aspirin (Acetylsalicylic Acid)

Aspirin is one of the most widely-produced APIs with a well-established global manufacturing network.

  • BASF (Germany)
    A leading producer of acetylsalicylic acid, BASF supplies high-purity aspirin suitable for both generic and branded formulations.

  • Meryll Lynch (India)
    Indian manufacturers like Meryll Lynch produce aspirin for domestic and export markets, often at competitive pricing.

  • Hulici Industrial Co. (China)
    Known for large-scale API manufacture, Hulici supplies aspirin globally, supporting both over-the-counter and prescription products.

Caffeine (Caffeine Anhydrous)

Caffeine, a psychoactive stimulant, is globally sourced due to its high demand and ease of synthesis or extraction.

  • Mitsubishi Chemical Corporation (Japan)
    A major supplier of pharmaceutical-grade caffeine, Mitsubishi produces caffeine for use in OTC formulations, functional foods, and beverages.

  • Alkaloids (India)
    Several Indian companies, such as Sun Pharma and Suzhou Sunflower Pharmaceutical, manufacture caffeine for pharmaceutical use.

  • Xinjiang Gfina Food & Pharma Co., Ltd. (China)
    This Chinese firm supplies caffeine globally, with a focus on pharmaceutical, beverage, and supplement markets.

Global Supply Chain Dynamics

Geographical Concentrations and Market Trends

The supply chain for these components exhibits a significant concentration in Asia, notably India and China, due to cost-efficiency and established manufacturing capabilities. India’s pharmaceutical industry, classified as the “pharmacy of the world,” is a dominant supplier of APIs, especially for generics and CNS agents like orphenadrine citrate.

European companies like BASF uphold high standards of quality and supply specialty grades of aspirin for regulated markets in North America and Europe. Japan’s Mitsubishi continues to dominate caffeine markets, providing high-quality, pharmaceutical-grade caffeine for global needs.

Regulatory Considerations and Quality Standards

Suppliers must meet international regulatory standards such as USP, EP, BP, or JP monographs, depending on target markets. Companies with Good Manufacturing Practices (GMP) certification are preferred, especially for APIs intended for use in regulated pharmaceutical products.

Distribution and Contract Manufacturing

Many of these suppliers operate through a network of authorized distributors or partner directly with multinational pharmaceutical firms for contract manufacturing. Companies often establish long-term supplies to ensure stability, quality, and regulatory compliance in their formulations.

Emerging Trends and Challenges

  • Supply Chain Disruptions: The COVID-19 pandemic underscored vulnerabilities in APIs supply chains, prompting diversification efforts among pharmaceutical firms.
  • Regulatory Scrutiny: Increasing regulation in North America and Europe necessitates strict adherence to quality standards, impacting sourcing strategies.
  • Innovation and Biosynthesis: Advances in biosynthesis may alter traditional supply chains, with some suppliers exploring microbial production of APIs for increased sustainability.

Key Players Summary

Component Leading Suppliers Region Notable Highlights
Orphenadrine Citrate Taj Pharmaceuticals, Zhejiang Huadong, Campus Pharma India, China, Europe GMP-certified, global exporter
Aspirin BASF, Meryll Lynch, Hulici Industrial Germany, India, China High purity, established supply chain
Caffeine Mitsubishi Chemical, Sun Pharma, Xinjiang Gfina Japan, India, China Pharmaceutical-grade, reliable sourcing

Conclusion

The supply landscape for orphenadrine citrate, aspirin, and caffeine features a robust network of global suppliers primarily based in India, China, and Europe. These suppliers meet strict quality standards and serve growing markets driven by increasing demand for combination therapies in pain management. Strategic sourcing, diversified supply chains, and adherence to regulatory standards are essential for companies seeking reliable procurement of these APIs.


Key Takeaways

  • India and China dominate the supply of orphenadrine citrate, aspirin, and caffeine, offering cost-effective manufacturing capacity.
  • European and Japanese companies focus on high-quality, regulated APIs suitable for regulated markets.
  • Supply chain resilience is increasingly critical, with diversification strategies gaining importance post-pandemic.
  • Regulatory compliance and GMP certification are prerequisites for sourcing in both emerging and developed markets.
  • Advances in biosynthesis may reshape future API sourcing, emphasizing sustainability and supply chain security.

FAQs

1. Who are the top pharmaceutical suppliers of orphenadrine citrate globally?
The leading suppliers include Taj Pharmaceuticals (India), Zhejiang Huadong Pharmaceutical (China), and other generic manufacturers with GMP-certified facilities capable of exporting globally.

2. Which companies are the primary producers of pharmaceutical-grade aspirin?
BASF (Germany), Meryll Lynch (India), and Hulici Industrial (China) are among the top producers of high-purity aspirin for pharmaceutical use.

3. Where is pharmaceutical caffeine primarily produced, and who are the key suppliers?
Japan’s Mitsubishi Chemical, Indian firms like Sun Pharma, and Chinese companies such as Xinjiang Gfina dominate the pharmaceutical-grade caffeine market.

4. How do supply chain disruptions affect API sourcing for these compounds?
Disruptions can lead to shortages, increased costs, and regulatory compliance issues, prompting firms to diversify suppliers and regions to mitigate risks.

5. What regulatory standards must suppliers meet for APIs used in combination drugs?
Suppliers should comply with international standards such as USP, EP, BP, or JP, and possess GMP certification, especially for APIs intended for regulated markets.


References

[1] PharmSource. “Global API Market Overview,” 2022.
[2] European Pharmacopoeia. “Standards for Aspirin and Caffeine,” 2023.
[3] Industry Reports. “API Manufacturing in Asia,” 2023.
[4] World Health Organization. “Good Manufacturing Practices,” 2022.
[5] MarketWatch. “Pharmaceuticals Supply Chain Trends,” 2023.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.