Bulk Pharmaceutical API Sources for DARVON COMPOUND-65

Bulk Pharmaceutical API Sources for DARVON COMPOUND-65

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		Hg|d@Dq]@\bbbbfJSSimUSTs@@
ChemBridge		5216007
Sigma-Aldrich		C0750_SIAL
Sigma-Aldrich		C1778_SIAL
Sigma-Aldrich		C7731_SIAL
Sigma-Aldrich		C8960_SIAL

Bulk API Sources for Darvon Compound-65

Last updated: February 19, 2026

Summary:
Darvon Compound-65, containing propoxyphene napsylate and acetaminophen, is an opioid analgesic withdrawn globally due to safety concerns. Its API, primarily propoxyphene napsylate and acetaminophen, was produced by multiple manufacturers before the drug's market withdrawal. Current API sourcing options are limited, with many producers ceasing production or transitioning to alternative compounds.

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What is the Composition of Darvon Compound-65?

Darvon Compound-65 contains:

• Propoxyphene napsylate (20 mg per tablet)
• Acetaminophen (650 mg per tablet)

Manufacturers manufactured APIs for both active ingredients separately. Propoxyphene napsylate was produced primarily in the United States and Europe, while acetaminophen (paracetamol) is globally available from multiple suppliers.

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API Sources for Propoxyphene Napsylate

Past Producers:

• Abbott Laboratories (USA)
• Bayer AG (Germany)
• Mylan (US, Europe)

Current Availability:
No major pharmaceutical companies currently produce propoxyphene napsylate. Market withdrawal was mandated globally following safety warnings, and most APIs have exited production.

Alternative sourcing options (pre-withdrawal):

• Generic manufacturers supplied APIs before withdrawal.
• Contract manufacturing organizations (CMOs): Possible, but current availability is limited due to regulatory restrictions and safety concerns.

Regulatory status:
Propoxyphene was removed from U.S. and European markets in 2010-2011. Many countries also banned the drug following FDA and EMA advisories.

Market status:

• Supply chain: Virtually nonexistent now.
• Regulations: APIs classified as discontinued or restricted; importation or use is heavily regulated or banned.

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API Sources for Acetaminophen (Paracetamol)

Leading Suppliers:

• McNeil Consumer Healthcare (Johnson & Johnson): One of the largest producers globally.
• Sun Pharmaceutical Industries: Major generic supplier.
• Mylan: Wide API portfolio, including acetaminophen before market withdrawal of APIs like propoxyphene.

Production Capacity & Quality Standards:

• Produced in facilities compliant with Good Manufacturing Practices (GMP).
• Capacity exceeds 10,000 metric tons annually globally.
• APIs vary in purity; standard grades are ≥99% purity, suitable for pharmaceutical manufacturing.

Sources:

• China and India dominate global API manufacturing, including acetaminophen.
• Major API producers supply both branded and generic pharmaceutical companies.

Market dynamics:

• API prices range from USD 2,000 to 4,000 per metric ton (as of 2022).
• Supply has stabilized due to the widespread use and high demand for acetaminophen.

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Alternative API Production & Sourcing Strategies

Resourcing propoxyphene napsylate:

• Due to market withdrawal, sourcing APIs for Darvon Compound-65 is challenging.
• Some companies with existing stocks or retired production lines may consider re-establishment under regulatory approval, but this is unlikely without renewed demand.

Sourcing acetaminophen:

• Easily obtainable from multiple global suppliers.
• Consider ensuring API compliance with local regulations (e.g., USP, BP standards).

Regulatory considerations:

• Import restrictions on propoxyphene APIs due to safety concerns.
• Quality assurance required for APIs used in compounded formulations or refilled products.

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Summary of API Market Status: Darvon Compound-65 Components

API	Major Producers	Current Availability	Regulatory Status
Propoxyphene napsylate	Abbott, Bayer, Mylan (former)	Virtually unavailable	Withdrawn worldwide (2010-2011)
Acetaminophen	McNeil, Sun Pharma, Mylan	Readily available	Widely approved, high demand

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Key Takeaways

• The active ingredients for Darvon Compound-65 are propoxyphene napsylate and acetaminophen.
• Propoxyphene napsylate is no longer produced or available commercially due to safety-based market withdrawal.
• Acetaminophen APIs are widely available from multiple global suppliers, with established GMP standards.
• Sourcing APIs for Darvon Compound-65 now is primarily feasible for existing inventory, compounded formulations, or legacy stock.
• Regulatory restrictions significantly limit or prohibit the import or use of APIs for Darvon Compound-65 in many jurisdictions.

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FAQs

1. Can I source propoxyphene napsylate for manufacturing?
No. Major regulatory agencies globally have banned or withdrawn approval due to safety concerns, resulting in discontinued production. Only residual stocks or re-establishment under strict approval could permit limited supply.

2. Are there legal constraints on importing APIs for Darvon Compound-65?
Yes. Many countries ban or restrict importation of APIs used in withdrawn drugs, and regulatory authorities enforce compliance with safety and drug authorization standards.

3. Where can I obtain high-quality acetaminophen API?
From established manufacturers in China and India, such as McNeil, Sun Pharma, and Mylan, adhering to GMP standards.

4. Can I substitute propoxyphene napsylate with other APIs?
Clinical substitution requires regulatory approval. Sourcing APIs for Darvon Compound-65 without proper authorization could be illegal or pose safety risks.

5. What are the alternatives to Darvon Compound-65?
Other opioid analgesics with better safety profiles, such as tramadol or hydrocodone, are available with current regulatory approval.

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References

[1] U.S. Food and Drug Administration. (2010). FDA Drug Safety Communication: FDA urges removal of certain prescription pain medications containing propoxyphene. Retrieved from https://www.fda.gov

[2] European Medicines Agency. (2011). Withdrawal of propoxyphene-containing medicines. EMA/587692/2010.

[3] WHO. (2022). WHO Pharmaceutical Pricing and Purchasing. API Market Report.

[4] GlobalSource Partners. (2022). API Market Trends and Price Listings.

[5] Johnson & Johnson. (2021). Acetaminophen API Quality Standards.

[6] India Ministry of Commerce. (2022). API Export Data.