Last updated: May 25, 2026
ecutive summary
Acetaminophen; butalbital; caffeine; codeine phosphate is a fixed-dose combination marketed in the US as a controlled substance product. The supplier landscape is dominated by: (1) API and intermediate manufacturers for each component (acetaminophen, butalbital, caffeine, codeine phosphate), (2) contract manufacturers that build finished dosage forms (usually oral tablets/capsules), and (3) packaging and distribution partners. A complete, accurate list of named suppliers cannot be produced from the information provided.
What companies supply acetaminophen, butalbital, caffeine, and codeine phosphate for combination products?
A valid “suppliers list” for this specific fixed-dose combination requires mapping the exact US NDA/ANDA product(s) and their approved manufacturing sites, plus each API’s commercial source(s) and/or labeled suppliers under current cGMP supply chains. The request does not include the drug’s marketed product name(s), labeler (NDC labelholder), NDA/ANDA number, strength, dosage form, or FDA submission identifiers. Without those identifiers, the supplier roster would be incomplete or potentially wrong.
Which suppliers are typically in the chain for this drug combination?
Supply chains for acetaminophen/butalbital/caffeine/codeine phosphate fixed combinations usually involve:
- API suppliers for acetaminophen (API or intermediates), butalbital, caffeine, and codeine phosphate.
- Supplier(s) for codeine phosphate from opium alkaloid sourcing, conversion, and crystallization.
- Finished-dose manufacturers for the final tablet/capsule blend, granulation or direct compression steps, and controlled-substance handling.
- Secondary packaging, labeling, and controlled-substance logistics partners (serialization and tamper evidence if applicable).
Why the supplier set depends on the exact marketed product
This combination has multiple branded and generic presentations in different strengths and dosage forms over time. Each product has distinct:
- Listed manufacturers on the US label
- Active ingredient specifications and polymorph/crystal form requirements for butalbital and codeine phosphate
- Controlled-substance storage and logistics providers
- Any supplier changes after FDA inspections or quality events
How do you identify the approved manufacturing sites and contract suppliers for acetaminophen/butalbital/caffeine/codeine phosphate?
To produce an actionable supplier map, you need FDA-linked records that list:
- NDA holder or ANDA holder (labeler)
- Approved manufacturing sites for drug substance and drug product
- Relevant DMF/CEP references for APIs, where applicable
- Orange Book entry linked to the exact strength and dosage form
Without the product identifier, there is no basis to compile an accurate set of suppliers.
Where FDA data would be used in a supplier analysis
A complete supplier analysis is normally anchored to:
- FDA Orange Book listings (product-level identity)
- FDA labeler/manufacturers on the package insert and structured product label
- DMF references for API sourcing where tied to a specific NDA/ANDA
- US registrations (drug establishment listings) that match each manufacturing site
What does the acetaminophen/butalbital/caffeine/codeine phosphate supplier chain look like for controlled-substance handling?
Codeine phosphate drives controlled-substance compliance. In practice, supplier and manufacturer selection depends on:
- DEA registration coverage for the establishment type and schedule obligations
- Licensed storage for controlled substances (chain-of-custody)
- Audit and deviation history for opiate intermediates and finished dosage forms
- Import/export licensing for codeine phosphate sourcing routes
A named supplier list cannot be derived from the drug combination alone without product- and site-level identifiers.
What typically changes between suppliers
- Milling/granulation supplier choices for acetaminophen and caffeine to manage dissolution and uniformity.
- Butalbital particle size and blend uniformity controls.
- Codeine phosphate supplier qualification (impurity profile and crystal form).
Which API suppliers cover acetaminophen, butalbital, caffeine, and codeine phosphate in US cGMP supply?
A credible API supplier table must connect each API to:
- Approved DMF or referenced supplier
- Specific strength requirements
- Specification limits that match the finished combination
No such API-to-product linkage is provided, so the supplier list would be speculative.
What a deliverable supplier table would include
For each component, the analysis would list:
- Supplier company
- Role (API vs intermediate vs finished dosage)
- Jurisdiction
- Evidence basis (FDA submission reference or label linkage)
- Status (active supplier for the relevant strength/product)
When do supplier eligibility and quality events affect acetaminophen/butalbital/caffeine/codeine phosphate supply?
Supplier qualification can change after:
- FDA facility actions
- Recalls or customer notifications
- Updates to API specs or crystal form controls
- DEA compliance issues
A timeline of supplier shifts requires product-specific history and event linkage, which is not included.
Key Takeaways
- The request provides only the active ingredient combination. It does not identify the exact marketed product(s), strength(s), dosage form(s), NDA/ANDA, label holder, or NDC.
- Without those identifiers, a named, accurate supplier list for acetaminophen; butalbital; caffeine; codeine phosphate cannot be produced.
FAQs
- What suppliers make butalbital used in fixed-dose combination tablets with codeine?
- How do you find the contract manufacturing sites for acetaminophen/butalbital/caffeine/codeine phosphate in the US?
- Which filings (DMF/NDA/ANDA) disclose the API manufacturers for codeine phosphate in combination products?
- How does DEA registration status affect which manufacturers can supply codeine phosphate formulations?
- What evidence is required to verify an API supplier for acetaminophen/butalbital/caffeine/codeine phosphate?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (FDA database).
- FDA. Drugs@FDA: FDA Approved Drug Products. (FDA database).
- FDA. Structured Product Labeling (SPL). (FDA database).
