Suppliers and packagers for cuprimine

cuprimine

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Valeant Pharms Intl	CUPRIMINE	penicillamine	CAPSULE;ORAL	019853	NDA	Bausch Health US, LLC	25010-705-15	100 CAPSULE in 1 BOTTLE (25010-705-15)	1970-12-04

CUPRIMINE (penicillamine) suppliers: key manufacturers, raw material sources, and supply-chain risk

Last updated: May 29, 2026

Who supplies CUPRIMINE (penicillamine) in the US and other markets?

CUPRIMINE is a brand of penicillamine (D-penicillamine and/or penicillamine isomer mix depending on label/region). Supply is typically split across: (1) API manufacturers for penicillamine, (2) dosage-form manufacturers for tablets/capsules, and (3) packaging and labeling partners used by brand holders or distributors.

Actionable supplier map (how CUPRIMINE supply chains are structured in practice):

• API suppliers (penicillamine): global fine-chemical and API manufacturers; penicillamine is produced from amino acid feedstocks via thiol/β-lactam intermediates and chiral/isomer control depending on process.
• Finished-dose manufacturers: solid-dose plants that press tablets or encapsulate oral penicillamine.
• Secondary packaging/labeling: packaging lines qualified for controlled handling, lot traceability, and label compliance.

Key constraint for supplier identification: CUPRIMINE supply visibility depends on Orange Book/ANDA listings (US) and local marketing authorizations (EU/UK/ROW). Without those country-specific regulatory identifiers, supplier names cannot be verified from authoritative public records.

Which companies manufacture penicillamine API used for CUPRIMINE?

Penicillamine API is sourced from manufacturers that produce small-molecule thiol APIs under GMP. API supply is usually governed by:

• stereochemistry control (quality and compliance for penicillamine specification)
• impurity profile (process-related impurities for thiol drugs)
• thiol oxidation handling (stability and storage conditions)
• lot-to-lot qualification for finished-dose formulation

Practical result: API sources for brands vary by year and lot, so a “single supplier” is rarely guaranteed long term.

What finished-dose manufacturers supply CUPRIMINE tablets/capsules?

Finished-dose production for penicillamine brands is typically handled by contract manufacturing organizations (CMOs) with:

• capability for potent/low-dose solid oral manufacturing (dose uniformity, segregation control)
• validated dissolution and content uniformity methods
• container closure system qualification for thiol oxidation sensitivity
• stability programs aligned to shelf-life claims

Practical result: the same API supplier can feed multiple finished-dose sites, while brands can shift finished-dose CMOs based on capacity and regulatory inspection outcomes.

How do wholesalers and distributors handle CUPRIMINE supply in the US?

US distribution commonly uses:

• primary distributors who manage chain-of-custody and cold/ambient requirements as specified
• secondary wholesalers that split distribution by region and account type
• pharmacy fulfillment networks for retail and 340B channels

Supplier risk concentrates in:

• distribution bottlenecks when API lead times extend
• allocation when finished-dose inventory is constrained
• tender and GPO contract cycles that pull demand forward

What raw material suppliers support CUPRIMINE penicillamine production?

Penicillamine supply chains rely on upstream specialty chemical inputs including:

• protected amino acid or thiol precursor intermediates
• sulfur-containing reagents used to form and maintain the thiol functionality
• chiral or isomer-control intermediates
• solvents and reagents qualified under ICH Q3A/Q3B-like impurity controls

Raw material suppliers are usually not “brand-named” publicly. They are controlled through qualified vendor lists and supplier audits by the API manufacturer.

What makes CUPRIMINE supply chain fragile?

For penicillamine brands, supply-chain constraints typically include:

• small market with concentrated API sourcing
• specialty thiol synthesis steps that limit scalable capacity
• stability and oxidation controls affecting shelf-life and rework risk
• GMP inspection outcomes that can pause production quickly
• regulatory and pharmacopoeial compliance requirements tied to thiol impurities

How many supplier candidates exist for CUPRIMINE, and what are the switches typically available?

Supplier diversification is possible but often limited by:

• validated processes for penicillamine specifications
• finished-dose formulation lock-down (bioequivalence and dissolution)
• packaging component approvals and change-control timelines

In practice, “switching suppliers” means:

• API change requires qualification, sometimes bridging studies depending on regulatory strategy
• finished-dose change requires tech transfer, stability updates, and regulatory listing updates

What regulatory filings reveal CUPRIMINE suppliers (Orange Book/ANDA/DMF)?

In the US, the most supplier-disclosing public artifacts are:

• FDA Orange Book entries (for listed drugs and patents)
• ANDA/Supplemental filings that sometimes include manufacturer information
• DMF public access does not always reveal names, but it can tie to sites in some cases
• labeler/distributor sections on FDA labeling databases

Without the specific FDA application/labeler details for CUPRIMINE, supplier names cannot be confirmed to a specific site or legal entity.

Which countries typically have CUPRIMINE distribution, and how do suppliers differ by geography?

Penicillamine brands are supplied differently across markets:

• US: brand-listed drug supply linked to FDA labeler and manufacturing sites.
• EU/UK: supply tied to marketing authorization holder and manufacturing authorization.
• ROW: distributor-driven supply where importer of record changes.

Geographic differences often reflect:

• local importers with tendering power
• licensing of manufacturing in-country vs. import-only supply
• drug product regulatory status and batch release requirements

What supplier and manufacturing risks matter for litigation or shortages involving CUPRIMINE?

Supplier disputes and shortage risk typically involve:

• API allocation during high-demand periods
• contract gaps between API manufacturer and finished-dose plant
• change-control disagreements over specs, impurities, or analytical methods
• GMP hold situations (deviations, OOS results, batch rejection)

These risks affect:

• lead times for re-supply
• ability to meet label packaging requirements
• time to release inventory after manufacturing

Key Takeaways

• CUPRIMINE penicillamine supply is constrained by thiol API manufacturing specificity and finished-dose GMP capacity.
• Supplier visibility in authoritative public records depends on FDA labeler/Orange Book or country marketing authorization identifiers.
• Supply chain fragility is driven by concentrated API sourcing, oxidative stability handling, and GMP inspection sensitivity.
• Supplier switching usually requires qualified API and finished-dose change-control, often with bridging and stability support.

FAQs

1. What is the typical API lead time for penicillamine (CUPRIMINE) and what drives delays?
2. How does switching penicillamine API suppliers affect impurity profiles and finished-dose specifications?
3. Which documentation (Orange Book, labeler info, manufacturing sites) is most reliable for identifying CUPRIMINE manufacturing contractors?
4. What are the common causes of penicillamine shortages related to thiol oxidation and GMP holds?
5. Do penicillamine tablet and capsule presentations have different manufacturing and packaging supplier requirements?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration.
2. FDA Drug Labeling and Label Information Resources. US Food and Drug Administration.
3. EMA European Public Assessment Reports (EPAR) and product information (when applicable). European Medicines Agency.