Last updated: May 26, 2026
COREG CR suppliers: Who manufactures and supplies Coreg CR (carvedilol CR) for US distribution
Executive summary: Coreg CR (carvedilol extended-release) is supplied in the US by GSK (brand owner/distributor). The supply chain is primarily tied to GSK’s commercial packaging and distribution, with manufacturing performed by contracted and/or internal sites. Specific contract-manufacturer identities and lot-level “supplier of record” details depend on the particular NDC strength/package and year-to-year manufacturing runs.
At a practical level for procurement, licensing, or regulatory planning, the actionable supplier universe for Coreg CR in the US is:
- Brand owner/distributor: GSK
- Manufacturing sites: GSK and/or qualified contract manufacturers supporting the commercial supply chain
- Downstream channels: wholesalers and specialty distributors carrying NDCs under GSK commercial supply programs
What companies supply Coreg CR (carvedilol extended-release) in the US?
Short answer: The US supply channel for Coreg CR is anchored by GSK as the brand holder/distributor. Manufacturing is performed by GSK and/or qualified third-party sites used for commercial production.
Who is listed as the labeler/distributor on Coreg CR NDCs?
For NDC-level supplier mapping, the relevant first stop is the FDA NDC Directory labeler field tied to each Coreg CR strength and dosage form. That labeler is the practical “supplier” most commercial systems reference for ordering, returns, and traceability.
Which role does GSK play in supply?
- GSK controls the brand’s US commercial supply chain through its labeler/distribution role.
- GSK also controls regulatory responsibility for the product as the holder of the listed application for the marketed product.
Which contract manufacturing organizations (CMOs) make Coreg CR tablets?
Short answer: The Coreg CR tablets are manufactured by GSK and/or CMOs. However, CMO identity is not reliably inferable from brand name alone; it must be mapped by current GMP manufacturing site listings and the specific NDC strength in the relevant FDA listing artifacts for the commercial product.
Where to verify CMO identity
- FDA facility and listing databases tied to the marketed product (strength/NDC specific)
- GMP manufacturing site identifiers on FDA listings and inspections
- Drug establishment registrations for the labeled product
Why CMO attribution changes
Manufacturing for extended-release oral products frequently rotates by campaign, site capacity, and validated process transfer status. That means CMO attribution can vary by year and even by strength.
How do you identify the “supplier of record” for Coreg CR NDC strengths?
Short answer: Use the NDC Directory labeler and then cross-check with FDA drug establishment registration and product-specific listing records for the current manufacturing site.
NDC-level mapping workflow (procurement-grade)
- Pull the exact NDC for the Coreg CR strength and package size you buy
- Use the FDA NDC Directory to identify the labeler
- Cross-check manufacturing site information through FDA establishment registration and drug product listing details tied to that NDC
What do wholesalers and distributors supply for Coreg CR?
Short answer: Coreg CR flows through conventional US pharmaceutical distribution networks. The orderable “supplier” from a customer standpoint is typically a wholesaler/distributor carrying GSK-labeled NDCs, while the regulated source is the branded product supply chain controlled by GSK.
Typical commercial supply chain structure
- GSK manufacturing release
- National wholesaler inventory stocking
- Customer ordering from a contracted wholesaler or specialty channel
- Pharmacovigilance and returns handled under the product’s GSK labeling identifiers
Are there multiple suppliers due to NDC/strength differences?
Short answer: Yes. Multiple manufacturing configurations can exist across strengths and packaging formats, even when the labeler remains GSK.
What changes between strengths
- Manufacturing site assignments may differ by:
- tablet strength
- packaging type
- market release timing
- batch-specific validated process parameters under the extended-release formulation platform
How does Coreg CR sourcing affect regulatory filings and traceability?
Short answer: Manufacturer and site selection affects:
- GMP release testing
- batch documentation traceability
- inspection readiness and audit outcomes
- supply continuity planning
What procurement teams should track
- NDC-specific manufacturing site and lot traceability
- change-control history at the site level
- stability and release testing linkage for extended-release profiles
How does Coreg CR compare with immediate-release Coreg in supply risk?
Short answer: Coreg CR supply continuity depends on sustained manufacturing capacity for extended-release tablet production. Immediate-release versions often have simpler release and formulation controls, but both products rely on qualified GMP sites.
Supply chain exposure drivers
- continued GMP staffing and validated ER process capability
- component availability for sustained-release matrices
- capacity constraints and inspection outcomes at manufacturing sites
Key Takeaways
- GSK is the practical US supplier anchor for Coreg CR via its labeler/distributor role.
- Manufacturing is performed by GSK and/or qualified contract manufacturers, with site attribution requiring NDC-strength-specific verification.
- For procurement, regulatory, or litigation readiness, supplier-of-record mapping must be NDC-driven using FDA NDC Directory and product listing/establishment data.
FAQs
- Which FDA-listed labeler supplies Coreg CR for each NDC strength?
- How can a buyer verify the GMP manufacturing site for the Coreg CR NDC they purchase?
- Do Coreg CR tablets have different manufacturing suppliers across packaging sizes?
- What documents should procurement request to confirm supply chain traceability for Coreg CR lots?
- How does NDC labeler data differ from actual manufacturing site identity for Coreg CR?
References (APA)
- FDA. NDC Directory (Coreg CR labeler and NDC listings). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ndc/
- FDA. Drug Establishment Registration and related establishment data. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-establishments-drug-product-listings-and-drug-registration-and-listing-process
