Last updated: June 5, 2026
Butalbital/acetaminophen/caffeine/codeine phosphate combination products in the U.S. are supplied through a supply chain that typically includes (1) API producers for each active (butalbital; acetaminophen; caffeine; codeine phosphate), (2) intermediate or salt form producers (codeine phosphate), and (3) contract manufacturers that blend, granulate, compress, package, and label the finished tablets/capsules. However, a complete, decision-grade “supplier list” tied to specific finished products (NDC-level), exact API source, and current approved manufacturers requires Orange Book and FDA drug establishment registration-linked data that is not provided here.
H1: Butalbital Acetaminophen Caffeine Codeine Phosphate Suppliers: API and Finished Dosage Manufacturers
Which companies supply butalbital for combination drugs like butalbital acetaminophen caffeine codeine phosphate?
Featured snippet (direct answer): Supplier identification depends on the specific NDC and the finished-goods applicant, because API origin can vary by lot and by contract manufacturing arrangement. A decision-ready supplier map requires FDA listing (NDC) and API traceability data.
API supply chain nodes for butalbital
- Butalbital (CAS 77-38-9) supply typically includes chemical synthesis manufacturers and specialty intermediates firms.
- For finished combination products, formulators usually buy butalbital from established chemical suppliers and qualify it for identity, assay, impurities, and polymorph/particle attributes.
What to look for in supplier disclosures
- DMF status (if applicable) and the listed manufacturer(s) for butalbital.
- Batch release testing and impurity profiles (not visible without regulatory dossiers or supplier qualification packages).
Which companies supply acetaminophen for fixed-dose combination analgesics with codeine?
Featured snippet (direct answer): Acetaminophen is supplied by a broad global set of API manufacturers; the relevant supplier set for your target product is determined by the listed finished drug manufacturer and its contracted API sources.
Acetaminophen supply characteristics
- Acetaminophen is widely produced and often available from multiple qualified vendors.
- Variation can occur in grade (particle size/flow), impurity control, and supply continuity.
Integration into combination tablet/capsule production
- Acetaminophen is commonly blended with caffeine and butalbital, then combined with codeine phosphate during final manufacturing steps.
Which companies supply caffeine API for butalbital-acetaminophen-codeine products?
Featured snippet (direct answer): Caffeine is commonly supplied by multiple API manufacturers; assignment to a specific finished product requires tying the finished product’s manufacturer to its quality-controlled API supply chain.
Caffeine API integration
- Caffeine (CAS 58-08-2) is usually supplied in a controlled specification for assay and impurities, then blended to tight uniformity targets.
- Combination products require uniform dispersion across tablet/capsule manufacturing.
Which companies supply codeine phosphate API for fixed-dose products?
Featured snippet (direct answer): Codeine phosphate is a regulated opioid API and is sourced from a narrower set of qualified suppliers. Supplier selection for a finished dosage form depends on the finished product applicant’s licensure, sourcing controls, and procurement network.
Regulated supply constraints
- Opioid APIs have higher audit and regulatory expectations around sourcing chain, documentation, and reconciliation.
- Codeine phosphate supply often depends on controlled procurement arrangements.
How do you identify the true suppliers for a specific NDC of butalbital/acetaminophen/caffeine/codeine phosphate?
Featured snippet (direct answer): The practical way is to start from the exact NDC and then map backward through:
- the FDA “drug product” listing for that NDC,
- the listed labeler/manufacturer,
- associated establishment registrations, and
- the ANDA/DMF trail if the product is generically sourced.
Data sources used in supplier mapping (when executed)
- FDA Drug Product Listing (NDC-level)
- FDA Orange Book (for product and applicant)
- FDA Establishment Registration and Drug Listing (manufacturing sites)
- DMF-linked API manufacturing names where available
- Litigation settlement filings sometimes identify or constrain sourcing and manufacturing responsibility
What finished-goods manufacturers produce butalbital/acetaminophen/caffeine/codeine phosphate tablets or capsules in the US?
Featured snippet (direct answer): Finished-goods manufacturers vary by NDC and by dosage form. Without an NDC list, a reliable manufacturer supplier table cannot be produced.
Finished dosage production responsibilities
- Blending and tablet/capsule formation
- Controlled substance handling and packaging
- GMP release and labeling
- Distribution through wholesalers under REMS/controlled substance requirements where applicable
What generic entrants affect supplier risk for butalbital-acetaminophen-caffeine-codeine phosphate?
Featured snippet (direct answer): Supplier risk is typically tied to which applicants hold current approvals and which ANDAs are in play, since paragraph IV litigation can force sourcing or manufacturing changes.
Common supplier disruption pathways
- Contract manufacturing site changes after litigation or recall
- Regulatory holds that restrict lot release
- Temporary API shortages for controlled substance APIs (codeine phosphate)
How strong is the IP and regulatory wall around butalbital-acetaminophen-caffeine-codeine phosphate manufacturing?
Featured snippet (direct answer): IP strength and exclusivity can affect which manufacturers can launch or remain on-market, indirectly changing supplier networks. A correct assessment requires Orange Book patent and exclusivity status per NDC.
Typical patent categories to check
- Formulation patents (ratios, compositions, tablet/capsule processing)
- Method-of-manufacture patents (granulation, compression, coating)
- Method-of-use patents (less common for older combination analgesics but possible)
What supplier list should a buyer request from vendors for this combination product?
Featured snippet (direct answer): Buyers should require documentary proof of controlled substance API sourcing and GMP compliance tied to the specific dosage form spec.
Vendor documentation checklist
- GMP compliance certificates for each manufacturing site
- API certificates of analysis including impurity profile
- Controlled substance chain-of-custody and reconciliation documentation for codeine phosphate
- Change control history for the API specifications
- Stability data for the finished combination dosage form (if vendor supplies finished goods)
Key Takeaways
- A “suppliers list” for butalbital/acetaminophen/caffeine/codeine phosphate must be anchored to specific NDCs and FDA listings; otherwise supplier identification cannot be made decision-grade.
- The supply chain has four parallel API streams (butalbital, acetaminophen, caffeine, codeine phosphate) plus finished-goods manufacturing and packaging under GMP and controlled substance handling.
- Supplier risk is driven by (a) codeine phosphate controlled API sourcing constraints and (b) NDC-specific finished product approval and litigation dynamics.
FAQs
1) How do I confirm API manufacturers for codeine phosphate used in a specific combination product?
Start with the exact NDC, pull the FDA listing and applicant/manufacturer, then map back via manufacturing responsibility disclosures and any DMF references tied to the product.
2) What documentation should a contract manufacturer provide for controlled substance handling of codeine phosphate?
GMP site qualification, controlled substance chain-of-custody and reconciliation process documentation, batch release documentation, and COAs with impurity specs.
3) Do API suppliers change across lots for butalbital-acetaminophen-caffeine-codeine phosphate products?
Yes, depending on qualification status, supply availability, and change-control approvals; lot-to-lot API origin requires vendor qualification records.
4) Which regulatory listings determine who manufactures the finished tablets or capsules?
FDA drug product listings (NDC-level) and establishment registrations for the finished drug manufacturer.
5) How does paragraph IV litigation affect supplier sourcing for this combination?
It can change which applicant supplies the market and can trigger manufacturing site or process shifts after settlements, regulatory actions, or launch timing changes.
References
No sources were provided in the prompt, and no external FDA/Orange Book/DMF dataset was supplied for citation.
