ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE: Pharmaceutical manufacturers, suppliers, and wholesalers

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Overview

In the complex landscape of pharmaceutical manufacturing and distribution, identifying reliable suppliers for active pharmaceutical ingredients (APIs) is fundamental to ensuring drug quality, regulatory compliance, and cost-effectiveness. This report delineates key suppliers for three widely used pharmaceuticals: Aspirin (acetylsalicylic acid), Caffeine, and Orphenadrine Citrate. Understanding supplier bases globally is essential for stakeholders involved in drug development, procurement, and supply chain management.

Aspirin: Global Supplier Landscape

Aspirin remains one of the most extensively used over-the-counter (OTC) analgesic and anti-inflammatory agents. Its global production hinges primarily on key API manufacturers that supply both branded and generic formulations.

Leading Aspirin API Suppliers

Hubei Saintpharma Chemical Co., Ltd. (China)
- One of the prominent bulk API producers, offering high-quality acetylsalicylic acid.
- Known for competitive pricing and compliance with international GMP standards.
Hunan Huatian Pharmaceutical Co., Ltd. (China)
- Major supplier with extensive manufacturing capacity; supplies globally.
- Focuses on quality control aligned with US and EU standards.
Malerba Group (India)
- A vertically integrated API and finished formulation manufacturer.
- Offers both API and finished aspirin products tailored for global markets.
Sichuan Blue View Pharmaceutical Co., Ltd. (China)
- Supplies bulk aspirin used in both pharmaceuticals and generics markets.
- Notable for reliable quality and regulatory compliance.
Akorn (USA) (for finished products)
- While primarily a finished dosage manufacturer, Akorn sources APIs from multiple suppliers, including Indian and Chinese manufacturers.

Market Considerations

Chinese and Indian API manufacturers dominate due to cost advantages.
Stringent quality controls are imperative for manufacturers to meet FDA and EMA standards.
Supply chain stability can be affected by geopolitical tensions and trade tariffs.

Caffeine: Suppliers and Production Hubs

Caffeine, a central nervous system stimulant, is produced both synthetically and extracted naturally from coffee and tea. The chemical’s APIs are produced mainly in Asia, with notable contributions from Europe and North America.

Major Caffeine API Suppliers

Jiangsu Tiansong Chemical Co., Ltd. (China)
- Leading synthetic caffeine producer with extensive export experience.
- Supplies pharmaceutical, food, and beverage industries.
Hubei Minde Chemical Co., Ltd. (China)
- Focuses on fine chemicals including caffeine.
- Noted for high purity standards suitable for pharmaceutical applications.
Genscript (USA)
- Provides custom synthesis services for caffeine and derivatives.
- Supplies research-grade caffeine and specialty products.
Funho Chemical Co., Ltd. (South Korea)
- Known for high-quality caffeine production and global distribution.
CXG Pharma (India)
- Focuses on the manufacture of pharmaceutical-grade caffeine for regional and international markets.

Industry Trends

Synthesis dominates caffeine supply due to cost efficiencies.
Natural extraction sources are limited and usually serve niche markets.
Purity standards (typically >99%) are critical when used in pharmaceuticals, necessitating rigorous quality assurance.

Orphenadrine Citrate: Supply Chain and Major Suppliers

Orphenadrine Citrate is a muscle relaxant with analgesic properties, mainly used in the treatment of muscle pain and spasms. Its production is narrower compared to aspirin and caffeine, with a concentrated supplier base.

Key API Suppliers of Orphenadrine Citrate

Xinhua Pharmaceutical (China)
- A leading manufacturer supplying pharmaceutical APIs including orphenadrine citrate.
- Emphasizes compliance with GMP standards and international export requirements.
Hubei Prime Pharmaceutical Co., Ltd. (China)
- Supplies orphenadrine citrate globally, ensuring quality and regulatory adherence.
Roche (Switzerland) (for finished formulations)
- Once a key provider of orphenadrine, primarily sourcing from Chinese manufacturers for raw APIs.
Aurobindo Pharma (India)
- Produces both API and finished formulations for orphenadrine citrate, serving global markets.

Supply Chain Considerations

The API's limited manufacturing base implies potential supply constraints but benefits from regulatory oversight by well-established players.
Chinese API manufacturers dominate due to cost advantages; however, quality assurance and certification are critical.

Regulatory and Quality Standards

Suppliers of aspirin, caffeine, and orphenadrine citrate must comply with international standards including GMP (Good Manufacturing Practice), ISO certifications, and pharmacopoeial specifications (USP, EP, BP).

Chinese suppliers often seek to align with global standards, facilitating export into regulated markets such as the US, EU, and Japan.
Indian suppliers also demonstrate strong compliance credentials, with several APIs approved by regulatory authorities.

Supply Chain Challenges and Opportunities

The pharmaceutical industry's dependence on Asian suppliers (notably China and India) presents both cost advantages and risks related to geopolitical tensions, supply chain disruptions, and regulatory scrutiny. Diversification and quality assurance are vital for procurement strategies.

Moreover, the increasing emphasis on sustainable manufacturing and traceability is likely to influence supplier selection, favoring those with transparent supply chain practices and compliance records.

Key Takeaways

Aspirin APIs are predominantly produced in China and India, with leading suppliers like Hubei Saintpharma and Malerba Group. Ensuring GMP compliance is critical due to market and regulatory demands.
Caffeine is mainly supplied by Chinese manufacturers such as Jiangsu Tiansong and Hubei Minde, with synthetic production dominating the industry. Purity and quality are paramount for pharmaceutical-grade caffeine.
Orphenadrine Citrate has a concentrated supplier base, mainly Chinese firms like Xinhua Pharmaceutical, with Indian manufacturers such as Aurobindo Pharma also active in the space.
The vendor selection should prioritize compliance, track record, and supply reliability. Diversifying suppliers and establishing long-term partnerships are recommended to mitigate geopolitical and supply chain risks.

FAQs

1. How do I verify the quality of pharmaceutical API suppliers?
Regulatory compliance documentation (GMP certifications, ISO standards), third-party audits, and active regulatory approvals (FDA, EMA) are key indicators. Additionally, audits and quality assurance programs should confirm batch consistency and purity.

2. Are Chinese and Indian API manufacturers reliable for regulated markets?
Yes, many Chinese and Indian manufacturers meet stringent international standards and possess certifications recognized by global regulators—yet thorough due diligence and supplier audits are essential before procurement.

3. What are the risks associated with sourcing APIs from Asia?
Risks include supply chain disruptions due to geopolitical issues, quality variability, and regulatory challenges. Developing diversified supplier networks and ongoing quality monitoring mitigate these risks.

4. How does the regulatory landscape influence API supplier selection?
Regulatory bodies require compliance with GMP and pharmacopoeial standards. Suppliers with established regulatory approvals expedite market entry and maintain product lifecycle integrity.

5. Will the supplier landscape for these drugs change in the coming years?
While manufacturing hubs remain primarily in Asia, regulatory pressures and sustainability trends may lead to increased manufacturing in other regions or the adoption of more stringent supply chain standards globally.

References

U.S. Pharmacopeia (USP). Aspirin Monograph.
European Pharmacopoeia (EP). Caffeine Monograph.
Pharmaceutical Technology. API manufacturing landscape.
Market analyses by IQVIA and GlobalData on pharma API suppliers.
World Health Organization (WHO). Good Manufacturing Practices Guidelines.

This comprehensive overview provides business professionals with essential insights into the supplier base for aspirin, caffeine, and orphenadrine citrate—supporting strategic procurement and risk management decisions in the pharmaceutical industry.

Suppliers and packagers for generic pharmaceutical drug: ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE