Subscribe to access the full database, or Get Started Free
Vendor	Vendor Homepage	Vendor Sku	API Url
BenchChem	⤷ Get Started Free	B1203322	⤷ Get Started Free
THE BioTek	⤷ Get Started Free	bt-1542930	⤷ Get Started Free
J&H Chemical Co.,ltd	⤷ Get Started Free	JH286193	⤷ Get Started Free
J&H Chemical Co.,ltd	⤷ Get Started Free	JH286197	⤷ Get Started Free
>Vendor	>Vendor Homepage	>Vendor Sku	>API Url

Last updated: December 12, 2025

Summary

This comprehensive review explores the global landscape for bulk Active Pharmaceutical Ingredient (API) sourcing of acetaminophen and propoxyphene hydrochloride. It elucidates the key manufacturing regions, regulatory considerations, quality standards, and supply chain dynamics that influence procurement strategies for these APIs. In the current regulatory environment, particularly with changing approvals and safety profiles, understanding sourcing channels becomes critical for pharmaceutical companies to ensure supply security, compliance, and cost-effectiveness.

What Are the Main Global Sources for Acetaminophen API?

Overview of Acetaminophen API Manufacturers

Acetaminophen (paracetamol) is one of the most widely used analgesic and antipyretic agents globally. Its API manufacturing is highly consolidated, with several established suppliers primarily located in Asia, Europe, and North America.

Major Manufacturing Countries

Country	Notable API Producers	Estimated Market Share	Regulatory & Quality Standards
China	Hubei Huacan Pharmaceutical, Shandong Xinlong Pharmaceutical, Zhejiang Kangle Pharmaceutical	>50%	CN-GMP, ISO 9001, US FDA (certification for export)
India	Aarti Industries, Granules India, Hetero Labs	~20%	cGMP, WHO-GMP, US FDA, EMA compliance
Europe	Bayer, Recipharm (Sweden), Sanofi (France)	~15%	EU-GMP, FARMA, US FDA
United States	Par Pharmaceutical, Teva Pharmaceuticals	~10%	US FDA

Supply Trends and Capacity

China dominates production, leveraging cost advantages and established infrastructure.
India has expanded capabilities to meet GMP standards, increasing export volumes.
European and American manufacturers emphasize high-quality standards, often serving niche markets and specialty formulations.

Manufacturing Standards and Quality Controls

cGMP Compliance: The foundation of API quality, mandatory for APIs destined for regulated markets.
Certifications: ISO 9001, ISO 14001, and other quality assurances bolster supply reliability.
Batch Consistency: Critical for ensuring therapeutic safety and efficacy.
Environmental and Safety Protocols: Adherence to environmental regulations like China’s Environmental Protection Law impacts capacity and sourcing stability.

Regulatory Considerations for Acetaminophen API

FDA and EMA Certifications: Necessary for APIs used in products marketed in US and European markets.
Pre-approval Inspections: Manufacturing facilities undergo routine audits for compliance.
Import Tariffs and Trade Policies: Ongoing trade tensions and tariffs influence sourcing costs and strategic decisions.

What Are the Key API Sources for Propoxyphene Hydrochloride?

Overview and Market Status

Propoxyphene hydrochloride, once a common opioid analgesic, has been withdrawn from many markets due to safety concerns related to cardiovascular and overdose risks[1]. Nonetheless, APIs and raw material sourcing still exist in specific regions, often for research, compounding, or legacy formulations.

Manufacturing Countries & Key Suppliers

Country	Notable API Participants	Market Relevance	Regulatory Context
India	McLeod Russel, Granules India	Responsible for residual production	GMP, WHO-GMP, US FDA for compliant APIs
China	Shanghai Xinyi Pharmaceutical	Limited, mainly for research	Less regulated, variable standards
Europe & North America	Market withdrawal has limited commercial supply	Mainly closed	Limited regulatory activity

Supply Chain and Availability

Legacy Supply: Certain producers still maintain API stocks for non-commercial or research purposes.
Quality & Regulatory Challenges: Many sources lack GMP certification; thus, APIs from these sources are not suitable for pharmaceutical manufacturing intended for regulated markets.
Supply Disruption Risks: Ongoing safety reevaluations and market withdrawal influence availability.

Regulatory and Safety Update

In 2010, the FDA recommended removing propoxyphene from the market due to safety issues, which led to withdrawal in the US. Several other regulators, including Health Canada and European authorities, issued similar guidance[2].

Market Withdrawals: Significant reduction in licensed manufacturing.
Residual API Use: Primarily used in compounded formulations and research settings where local regulations permit.

Comparison Summary Table

Attribute	Acetaminophen API	Propoxyphene Hydrochloride API
Major Production Regions	China, India, Europe, US	India, China (research use)
Regulatory Status	Widely approved, extensive regulation	Withdrawn or restricted, limited suppliers
Supply Chain Stability	High in China, increasing in India	Low, due to safety concerns and market withdrawal
Quality Standards	GMP, cGMP, ISO	Variable, often not GMP-compliant
Market Growth Drivers	Mass consumption, generic availability	Declining due to safety issues

In-Depth Analysis: Sourcing and Strategic Implications

For Acetaminophen

Asia-Pacific Dominance: The supply chain is heavily concentrated in China and India, offering cost efficiencies. However, regulatory scrutiny over ingredient quality and environmental compliance can impact supply stability.
Supply Chain Diversification: To mitigate risks, companies leverage multiple suppliers, including European and US-based manufacturers that primarily serve specialty markets.

For Propoxyphene Hydrochloride

Limited Availability: Since market withdrawal, API sourcing is restricted to legacy stocks, research suppliers, or compounding pharmacies.
Legal and Safety Risks: Due to contraindications and safety concerns, procurement from non-commercial sources warrants significant due diligence.

Comparison of Key API Suppliers: Features and Challenges

Feature	Acetaminophen API Suppliers	Propoxyphene Hydrochloride API Suppliers
Regulatory Compliance	Extensive GMP-certified producers	Few GMP-capable producers; often non-GMP
Certificate of Analysis (CoA)	Standardized CoA with batch data	Variably available; potential authenticity issues
Supply Stability	High, with multiple tiered sources	Low, due to market withdrawal and safety restrictions
Cost	Competitive in Asia	High, limited sources, or unavailable
Environmental Impact	Regulatory pressure in China to ensure environmental compliance	Not applicable due to limited production

Regulatory and Market Dynamics Impacting API Sourcing

Aspect	Impact on API Sourcing
Trade Policies	Tariffs, import restrictions affect costs, especially for Chinese imports
Environmental Regulations	Stricter enforcement in China may constrain supply volumes
Market Withdrawal & Safety Alerts	Reduced availability of propoxyphene APIs globally
Quality Expectations	Heightened due diligence for APIs intended for regulated markets
Supply Chain Transparency	Increasing demand for verified, traceable APIs to reduce counterfeiting and contamination risks

Conclusion

The API sourcing landscape for acetaminophen is robust, dominated primarily by Chinese and Indian manufacturers, with a strong presence of regulated suppliers compliant with GMP standards. This ensures a reliable supply chain for pharmaceutical companies, provided they adhere to regulatory requirements and verify supplier credentials. Conversely, propoxyphene hydrochloride's market has significantly contracted following safety withdrawals. Its sources are now limited, mainly for research or legacy manufacturing, with high risks associated with sourcing outside regulatory-approved channels.

Key Takeaways

For Acetaminophen:
- Consider diversified sourcing from Chinese, Indian, and European GMP-certified manufacturers.
- Monitor regulatory developments to ensure supplier compliance.
- Leverage supplier audits and CoA verifications for supply chain integrity.
For Propoxyphene Hydrochloride:
- Recognize the limited and declining availability due to market withdrawal.
- Procure only from licensed, GMP-certified sources for research or legacy formulations.
- Stay updated on regulatory advisories to prevent inadvertent procurement of unapproved APIs.
Regulatory Compliance:
- Continually monitor changing global regulatory standards to mitigate legal and quality risks.
Supply Chain Stability:
- Prioritize suppliers with transparent, traceable, and environmentally compliant manufacturing processes.
Strategic Planning:
- Develop contingency plans to adapt to market withdrawals or supply disruptions, especially for discontinued APIs.

FAQs

1. How do I identify GMP-certified API suppliers for acetaminophen?
Look for suppliers with certifications from recognized agencies such as US FDA, EMA, or WHO-GMP. Review their audit reports, batch records, and quality certificates, and conduct supplier audits when feasible.

2. Are there risks associated with sourcing APIs from Chinese manufacturers?
Yes. Potential risks include variable environmental compliance, quality inconsistencies, and regulatory scrutiny. Due diligence, comprehensive audits, and verification of certifications are essential.

3. Is propoxyphene hydrochloride API still accessible for pharmaceutical manufacturing?
Limited, mainly for research and legacy formulations. Its market withdrawal in many regions has curtailed commercial API production.

4. What are the key considerations when sourcing APIs for regulated markets?
Ensure GMP compliance, verified traceability, comprehensive quality documentation, and adherence to local regulatory approvals.

5. How do geopolitical tensions affect API supply chains?
Trade tariffs, export restrictions, and diplomatic relations can impact pricing, availability, and lead times for APIs, especially those from China and India.

References

[1] U.S. Food and Drug Administration. “Guidance on Propoxyphene Withdrawal,” 2010. [2] Health Canada. “Notice Regarding Propoxyphene,” 2010.

Bulk Pharmaceutical API Sources for ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE