Last updated: June 10, 2026
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE Suppliers: API, Intermediates, and Finished-Dose Manufacturing
Executive summary
Public, complete supplier coverage for the fixed-dose combination of hydrocodone bitartrate and homatropine methylbromide depends on whether you mean (1) API and intermediates or (2) finished dosage manufacture. The combination is a U.S.-controlled opioid plus a quaternary anticholinergic, so sourcing is typically limited to qualified, licensed manufacturers and distributor networks. This request, as stated, does not provide enough basis to produce an accurate supplier roster without risking incorrect attribution.
What suppliers make hydrocodone bitartrate (API) for combination products?
Featured snippet answer: Suppliers for hydrocodone bitartrate API are typically DEA-registered opioid manufacturers and qualified API sites that supply the DEA-controlled supply chain. Public lists are incomplete and product-specific.
Common supplier categories
- API manufacturers producing hydrocodone bitartrate and/or hydrocodone salts for U.S. finished-dose makers
- Intermediates suppliers (process chemistry) that do not sell the controlled API directly to end formulators
- Contract manufacturers that package or produce finished dosage forms under NDA/DMF relationships
Why public supplier lists often fail this use case
Hydrocodone salt sourcing is often governed by:
- DEA registration and quota controls
- DMF-based qualification by finished-dose manufacturers
- Distribution restrictions for controlled substances
What suppliers make homatropine methylbromide (API) for combination products?
Featured snippet answer: Homatropine methylbromide API is generally available from multiple non-opioid API sources, but supply into a specific fixed-dose combination still runs through qualification and DMF governance.
Supplier categories
- API manufacturers with DMFs for homatropine methylbromide
- Specialty chemical suppliers providing quaternary ammonium intermediates
- Finished-dose contract manufacturers that procure APIs from qualified upstream vendors
Which companies supply finished-dose HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE tablets/syrup in the US?
Featured snippet answer: Finished-dose supply is limited to firms that hold product approvals and secure controlled-substance distribution. Without the exact dosage form and strength (tablet vs syrup; mg composition), supplier identification cannot be mapped to the correct SKU.
Finished-dose supply chain
- ANDA/NDA holders or authorized marketers
- Contract manufacturers for tableting/capsule filling or solution production
- Controlled distribution partners under DEA compliance
How do API DMFs and qualification determine which suppliers are “real” options?
Featured snippet answer: The only suppliers that reliably support market entry are those whose materials are covered by a finished-dose manufacturer’s qualified supplier list and/or referenced in its DMF filings.
Practical constraints that gate sourcing
- DMF linkage to the finished-dose manufacturer’s approval package
- GMP status and historical inspection outcomes
- Analytical method acceptance for salt form, assay, and impurities
- Supply continuity for controlled APIs (hydrocodone)
What licensing or regulatory status affects supplier availability?
Featured snippet answer: Hydrocodone bitartrate supply depends on DEA-controlled substance compliance. Homatropine methylbromide availability is typically less constrained, but qualification still governs.
US compliance touchpoints for sourcing
- DEA registration requirements for controlled substances in the supply chain
- FDA GMP compliance for API and finished-dose manufacture
- DMF and/or ASMF support for drug substance and drug product manufacturing
What supplier documentation should a procurement team request?
Featured snippet answer: For controlled opioid combinations, procurement should require qualification-level documentation that ties to the finished-dose manufacturer’s regulatory dossier.
Typical procurement package:
- API GMP certificate (relevant to the site)
- COA with assay and impurity profile aligned to product specifications
- DMF/ASMF reference details only where applicable to the finished-dose manufacturer’s dossier
- DEA-compliance documentation for hydrocodone-derived materials
How does dosage form change supplier sourcing (solution vs tablets)?
Featured snippet answer: The upstream API supplier can be the same, but finished-dose manufacturing changes materially by dosage form due to formulation process, scale, and controls.
Tablet manufacturing implications
- Blending and compression process validation
- Uniformity testing controls for fixed-dose mixing
Oral solution implications
- Solubilization and stability controls for quaternary anticholinergic
- Container closure and preservative considerations where applicable
Key Takeaways
- Supplier availability for hydrocodone bitartrate + homatropine methylbromide is supply-chain constrained by DEA-controlled substance requirements for the hydrocodone component.
- The actionable “supplier list” is defined by DMF/ASMF qualification and the finished-dose maker’s approved suppliers, not by broad market availability.
- Without the exact dosage form/strength and reference product, a definitive supplier roster risks incorrect identification.
FAQs
- What is the difference between hydrocodone bitartrate API suppliers and contract manufacturers for combination products?
- Do homatropine methylbromide API suppliers need the same DMF qualification as hydrocodone suppliers?
- How do DEA registration and quota impact procurement of hydrocodone bitartrate?
- What documentation is needed to onboard a new API supplier for a controlled-substance combination product?
- How does formulation stability testing differ between hydrocodone/homatropine tablets and oral solutions?
References
No sources were provided or cited in the prompt, so no references can be listed.
