Last updated: April 23, 2026
Who Supplies Acamprosate Calcium to the Pharmaceutical Market?
Acamprosate calcium is supplied through two channels: (1) manufacturers that produce acamprosate calcium API (active pharmaceutical ingredient) and (2) finished-dose producers that market acamprosate calcium tablets under their own brand portfolios. Below is the supplier landscape commonly used for sourcing and regulatory planning, organized by supply role.
API Producers: Who Manufactures Acamprosate Calcium API?
The global acamprosate calcium API supply base is dominated by established generics/API manufacturers. Key supplier categories for procurement diligence include:
- Route-of-synthesis API manufacturers (produce acamprosate calcium API for generics and contract customers)
- DMF holders and Abbreviated New Drug Application (ANDA) supply-chain API sources (API qualification via regulatory filings)
- Contract manufacturing organizations (CMOs) that produce API or intermediate conversion steps under controlled quality agreements
Procurement reality: most buyer-ready acamprosate calcium API sourcing runs through distributors and qualified trading entities that can provide regulatory documentation (e.g., CoA, DMF/letter-of-access linkage, CEP/inspection history where applicable).
Finished-Dose Manufacturers: Who Makes Acamprosate Calcium Tablets?
Acamprosate calcium is sold primarily as oral tablets, typically under the trade name Campral (brand) and multiple generic equivalents. Finished-dose supply is usually offered by:
- Originator supply (brand product manufacturing and secondary packaging)
- Generic tablet manufacturers in Europe and other regulated markets
- White-label / parallel trade channels depending on region
Buyer implication: many procurement teams source the finished dose from local EU/US-distribution partners for lead-time stability, while qualifying API separately for custom manufacturing or portfolio expansion.
Brand and Generic Supply Structure
Originator/Reference Product
- Campral is the best-known acamprosate calcium reference brand in major markets.
Generic Equivalents
Multiple generic versions exist in most jurisdictions with marketing authorizations that support substitution. These products typically reference established impurity profiles and dissolution behavior.
How Suppliers Are Typically Qualified (Practical Sourcing Checklist)
When selecting an acamprosate calcium supplier, buyers typically validate these items in the quality package:
- API quality documentation: CoA, impurity profile consistency, traceability batch records
- Regulatory support: DMF/ASMF ownership or right-of-reference/letter of access
- Compliance evidence: GMP inspection history, site qualification status
- Physical/chemical specs: identity (assay), moisture/solvent residual limits (per supplier’s validated method and regulatory submission)
- Manufacturing controls: change control history and stability data for the specific supplier batch series
Key Market Sourcing Paths
1) Direct from API manufacturers
Best for large-volume programs and when you can manage DMF/ASMF and quality agreements.
2) Through distributors of qualified API
Best when you need faster availability, regional coverage, and documentation packaging.
3) Through finished-dose manufacturers
Best for commercial product supply, where formulation and packaging are already validated.
Key Takeaways
- Acamprosate calcium supply is split between API manufacturers and finished-dose tablet producers, with distributors often acting as the interface for qualified regulatory documentation.
- The procurement target is not “any supplier,” but one that can provide regulatory linkage (DMF/letter-of-access) plus batch-consistent quality packages.
- For commercial programs, buyers commonly secure finished-dose supply first, then decide whether to qualify API separately for scale-up or custom manufacturing.
FAQs
1) Is acamprosate calcium supplied more as API or as finished tablets?
It is supplied in both formats, but day-to-day procurement for most commercial portfolios starts with finished-dose tablets, while API sourcing is common for manufacturing partners and custom production.
2) What documentation should a supplier provide for acamprosate calcium API?
At minimum: Certificate of Analysis, validated specifications (assay/impurities), and regulatory support such as DMF/ASMF linkage where applicable.
3) Can acamprosate calcium be sourced through distributors?
Yes. Many buyers source via distributors that bundle CoAs and regulatory documentation from qualified upstream manufacturers.
4) Does the supplier need to match the regulatory submission source?
For an ANDA/marketing authorization supply chain, consistency with the filing-linked API source (DMF/ASMF or equivalent regulatory reference) is usually required.
5) What is the main sourcing risk with generic acamprosate calcium?
Quality and regulatory alignment across batches, especially around impurity profile consistency and documentation rights to the approved API dossier.
References
[1] European Medicines Agency (EMA). Campral (acamprosate) product information and assessment materials. EMA. https://www.ema.europa.eu/
[2] FDA. Drug Approval Reports and generic drug application information for acamprosate (where applicable). U.S. Food and Drug Administration. https://www.fda.gov/drugs/
[3] ICH. Guidance for specifications and impurity/quality documentation (general framework relevant to API sourcing qualification). International Council for Harmonisation. https://www.ich.org/
