Last updated: May 26, 2026
COTEMPLA XR-ODT suppliers: API, finished-dose, and key subcontract manufacturing partners
Executive summary: Public, source-specific supplier identification for COTEMPLA XR-ODT (methylphenidate hydrochloride extended-release orally disintegrating tablet) is not determinable from the information provided. No verified list of API manufacturers, tablet compression/ODM suppliers, blister/packaging partners, or contract manufacturers can be produced without specific, citable supply-chain disclosures (e.g., FDA inspection records tied to label sites, current Good Manufacturing Practice site authorizations in regulatory filings, or supplier lists in published manufacturing agreements).
What companies supply COTEMPLA XR-ODT (methylphenidate) to the US market?
No complete, defensible supplier set can be stated.
What supplier types exist in the COTEMPLA XR-ODT value chain
- API supply (methylphenidate HCl)
- Finished-dose manufacture (extended-release ODT)
- Film coating or matrix formation (if applicable to this specific design)
- Blistering or bottle packaging
- Labeling, secondary packaging, and distribution
What to look for in primary evidence
- Establishment inspectional data tied to drug-product manufacturing sites
- Orange Book “Manufactured for” and “Distributed by” label lines
- NDA/label manufacturing sections listing drug-product and packaging locations
- Drug master file (DMF) access patterns for API grades (only if disclosed in FDA records)
Which API manufacturers make methylphenidate hydrochloride for COTEMPLA XR-ODT?
No verified API supplier list can be produced.
How API supplier identification typically happens
- Through DMF references cited by FDA in approval documents or supplement records
- Through establishment-level GMP records for API
- Through supply-chain statements in filings (rare for finished branded products)
Which contract manufacturers build COTEMPLA XR-ODT tablets (ODT) under private label or outsourcing?
No verified contract manufacturing partners can be stated.
What contract-manufacturing evidence would be required
- FDA site inspection classification and drug-product manufacturing address mapping to the labeled “Manufactured by” and “Packaged by” lines
- Multi-source manufacturing transfer history from supplements (manufacturing site changes)
- Litigation or whistleblower documents naming production sites (only if citable)
What packaging and logistics suppliers handle COTEMPLA XR-ODT (blister vs bottle)?
No verified packaging-supplier roster can be produced.
Packaging work that can be subcontracted
- Cold-form blister lamination and forming (if blister)
- Unit-dose lidding and cartoning
- Bottle filling and desiccant handling (if bottle)
How can Orange Book listings identify COTEMPLA XR-ODT manufacturing sites and suppliers?
No Orange Book-driven manufacturing supplier extraction can be produced from the information provided.
Orange Book fields that can support supplier mapping
- Applicant (NDA holder)
- Dosage form and strength
- Labeler/manufacturer statements (when present)
- Patent and exclusivity status (does not reliably enumerate supplier sites)
Who is the NDA holder and how does that affect supplier selection for COTEMPLA XR-ODT?
No NDA-holder-specific supplier mapping can be provided from the information provided.
Typical supplier allocation under an NDA holder
- NDA holder may own the drug-product site or use contract manufacturing
- Packaging can be a separate contracted establishment even when drug product is internal
What supplier risks matter for COTEMPLA XR-ODT (shortages, ODT capacity, raw-material constraints)?
No COTEMPLA XR-ODT-specific risk quantification can be produced without supplier site and capacity data.
Risk categories to assess once sites are identified
- ODT forming and dissolution performance consistency
- Extended-release technology robustness (matrix integrity)
- Methylphenidate raw material lead times
- Regulatory and audit history per site
- Controlled substance supply chain compliance
Key Takeaways
- A verified supplier list for COTEMPLA XR-ODT (API makers, contract manufacturers, packaging partners) cannot be produced from the current prompt.
- Supplier identification requires citable manufacturing-site evidence tied to the product’s approved labeling and FDA regulatory records.
FAQs
- Who manufactures the finished-dose COTEMPLA XR-ODT tablets in the US?
- Which companies supply methylphenidate HCl API for COTEMPLA XR-ODT?
- What contract manufacturing model is used for COTEMPLA XR-ODT (in-house vs outsourced)?
- How do you map packaging suppliers for COTEMPLA XR-ODT from regulatory documents?
- What supplier bottlenecks most often drive ODT shortages for extended-release methylphenidate products?
References
- FDA Orange Book. U.S. Food and Drug Administration.
- FDA Drugs@FDA. U.S. Food and Drug Administration.
