Last updated: May 29, 2026
Acetaminophen and Codeine Phosphate Suppliers (API, Finished Dosage, and Contract Manufacturing)
Executive summary: Suppliers span (1) API makers for codeine phosphate and (2) acetaminophen API and (3) finished-dose manufacturers of acetaminophen/codeine phosphate tablets (and, where approved, combination liquids). The supplier set is dominated by large Indian and Chinese generics/API companies for APIs and by multi-market finished-dose manufacturers that can support FDA supply continuity, labeling, and DEA-controlled handling for codeine.
Who supplies acetaminophen and codeine phosphate tablets in the US?
Featured “supplier” lists for this combination typically split into two layers: API supply and finished-dose (NDC) manufacturing. For acetaminophen/codeine phosphate, the practical supplier universe for commercial risk control is finished-dose manufacturers holding FDA approvals and supply contracts, with API sources used to validate sourcing continuity and cost.
Finished-dose manufacturing (tablets) and NDC supply
In practice, the US market for acetaminophen/codeine phosphate products is served through:
- ANDA holders manufacturing and releasing under FDA-approved processes.
- Contract manufacturers (CMOs) that build on behalf of ANDA holders under approved controls.
- Parallel re-packers and secondary distributors that move product, but do not control manufacturing approvals.
Core supply diligence targets:
- NDC-specific manufacturer/release sites.
- DEA registration and controlled-substance supply chain coverage for codeine handling.
- Quality system evidence for combination products (blend uniformity, dissolution/assay, stability).
API suppliers for acetaminophen and codeine phosphate
API sourcing is typically:
- Acetaminophen API from multiple global producers with established inspection histories.
- Codeine phosphate API from producers that can supply controlled-substance precursors and codeine salts under compliance programs.
Key diligence targets:
- Written supply continuity plans for codeine phosphate.
- Consistency of polymorph/grade specs and impurity profiles that match finished-dose acceptance criteria.
- Batch release testing alignment for combination tablets.
What companies supply acetaminophen API and codeine phosphate API?
This combination is only as reliable as its API continuity. Supply risk clusters around:
- Codeine phosphate availability and compliance logistics.
- Batch-by-batch impurity controls that must match ANDA release specs.
- Inspection readiness for GMP sites.
Acetaminophen API supplier criteria (what buyers screen)
- cGMP compliance and recent inspection outcomes
- tight impurity specifications (acetaminophen-related impurities)
- polymorphic/particle size control where relevant to tablet performance
- reliable long-term supply contracts
Codeine phosphate API supplier criteria (what buyers screen)
- DEA-controlled substance capability and audited distribution
- traceability from licensed manufacture through import and receipt
- stable assay and impurity profiles
- validated compliance for salt form and physical attributes
How do finished-dose suppliers obtain codeine for acetaminophen/codeine phosphate?
Finished-dose manufacturers must secure codeine supply via DEA-controlled channels.
- Codeine phosphate arrives as API (most common) or under compliant procurement arrangements that preserve traceability.
- Manufacturing must support controlled substance chain-of-custody, including receiving, storage, reconciliation, and destruction protocols.
- Release testing integrates assay for codeine and acetaminophen, plus blend uniformity and dissolution.
What suppliers manufacture acetaminophen and codeine phosphate for multiple NDCs?
A common market structure is:
- Large ANDA manufacturers that run multiple strengths under one platform.
- Shared CMO sites that produce for different labelers under controlled contracting.
- Multi-site supply used to manage outages in controlled-substance API logistics.
Buyer diligence focuses on:
- shared facility dependencies that create correlated risk (same API source, same CMO line, same controlled storage).
- whether the labeler is the actual manufacturer of record versus only the marketer.
Which contract manufacturing organizations (CMOs) produce acetaminophen and codeine phosphate tablets?
CMOs generally support combination analgesics where:
- tablet compression and coating capacity is established,
- controlled-substance handling processes exist for codeine,
- and regulatory filings can support current Good Manufacturing Practice at each site.
Key screening points:
- DEA registration for controlled-substance manufacturing activities at the site
- validated cleaning and cross-contamination controls
- demonstrated ability to meet dissolution and content-uniformity targets for opioids + acetaminophen blends
What are the FDA and DEA compliance requirements suppliers must meet?
For the supplier chain:
- FDA cGMP applies to manufacturing, testing, and release.
- DEA applies to codeine handling (manufacture, distribution, import/export, recordkeeping, reconciliation).
- Importers must ensure approved regulatory status and documentation aligned with controlled substances and APIs.
Operational requirements that affect supplier eligibility:
- controlled substance storage security,
- audit trails and reconciliation,
- validated transfer procedures from receipt to manufacturing to destruction.
What patent and exclusivity issues affect supplier approvals for acetaminophen and codeine phosphate?
For a longstanding combination like acetaminophen/codeine phosphate, the product is generally in the generic and multiple-ANDA landscape rather than a single exclusivity monopolization regime. As a result, supplier entry is typically constrained less by “exclusive patents” and more by:
- regulatory readiness (ANDA comparability),
- controlled-substance supply continuity,
- and facility inspection status.
How strong is the supplier risk if codeine phosphate API supply is disrupted?
Buyer risk concentrates in:
- API lead times for codeine phosphate.
- batch rejection risk if impurity profiles shift.
- correlated manufacturing impacts if multiple labelers depend on a limited number of API sources.
Mitigations suppliers often implement:
- dual-sourcing codeine phosphate API,
- safety stock built around DEA-compliant procurement,
- qualification of alternate lots/suppliers under change-control frameworks.
What generic entry risks exist for acetaminophen and codeine phosphate?
Generic entrants face fewer formulation novelty barriers and more practical blockers:
- obtaining reliable codeine API supply,
- meeting dissolution and content uniformity specs,
- and passing facility inspection with no controlled-substance compliance gaps.
How does acetaminophen/codeine phosphate supply compare with other opioid/APAP combinations?
Compared with other combination opioids (example: hydrocodone/APAP), acetaminophen/codeine phosphate supply risk commonly depends on:
- codeine phosphate API availability
- DEA logistics and allocation patterns
- manufacturing capacity at sites already handling combination products
If buyers want lower correlated risk, they often:
- diversify across codeine and other opioid APIs,
- or ensure multiple independent API sources for the same active pharmaceutical ingredients.
Key supplier diligence checklist for acetaminophen and codeine phosphate
Use this to qualify and maintain continuity.
Regulatory and controlled-substance readiness
- DEA registration aligned with the site’s controlled-substance role
- FDA cGMP compliance at the manufacturing and testing sites
- validated controlled-substance inventory reconciliation
Quality and formulation performance
- batch uniformity and dissolution capability
- impurity profile control for both acetaminophen and codeine
- stability program coverage supporting labeled shelf life
Supply continuity and contracts
- dual-source codeine phosphate API qualification
- lead time and allocation terms for controlled substances
- change-control and lot-to-lot bridging documentation
Key Takeaways
- Supplier coverage for acetaminophen and codeine phosphate is best managed as a two-tier system: codeine phosphate API supply plus finished-dose manufacturing/NDC supply.
- The highest correlated risk sits in codeine phosphate API availability and the supplier chain’s ability to maintain DEA-compliant procurement and custody.
- For commercial resilience, buyers should qualify multiple codeine API sources and verify finished-dose manufacturing release sites with controlled-substance capability.
FAQs
- Which NDC manufacturers are the main suppliers of acetaminophen and codeine phosphate tablets in the US?
- What DEA compliance controls do suppliers need to handle codeine for this combination drug?
- How do codeine phosphate API impurity changes affect finished-dose batch release for acetaminophen/codeine tablets?
- What contract manufacturing capabilities matter most for opioid plus acetaminophen combination tablet production?
- What happens to supply continuity when codeine phosphate API lead times expand or allocations occur?
References
- U.S. Food and Drug Administration (FDA). Orange Book (Drug Products). https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Drug Enforcement Administration (DEA). Controlled Substances Registration and compliance guidance. https://www.deadiversion.usdoj.gov/
- U.S. FDA. Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals. https://www.fda.gov/
