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Suppliers and packagers for cotellic
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cotellic
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Genentech Inc | COTELLIC | cobimetinib fumarate | TABLET;ORAL | 206192 | NDA | Genentech, Inc. | 50242-717-01 | 63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50242-717-01) | 2015-11-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for COTELLIC (cobimetinib): API, fill-finish, and commercial supply chain
COTELLIC (cobimetinib) is supplied in the US by Genentech USA, Inc. (Roche). Public compendial and regulatory filings tie cobimetinib fumarate drug substance and finished dosage form supply to Roche/Genentech’s internal network and contracted manufacturers, with product release and commercialization under Genentech’s label ownership.
Who supplies COTELLIC in the US market?
Answer (featured-snippet): In the US, Genentech USA, Inc. is the marketing authorization holder and product supply entity for COTELLIC (cobimetinib) tablets, while Roche/Genentech’s global manufacturing network produces the drug substance and drug product under contracted facilities.
What company is listed as the US label holder?
- Genentech USA, Inc. is the US-listed manufacturer/labeler for COTELLIC (Rx product labeling).
What is the typical role of upstream “suppliers” for COTELLIC?
COTELLIC supply is structured as:
- API supplier (cobimetinib fumarate drug substance manufacturing)
- Excipients/packaging suppliers (formulation inputs and container-closure systems)
- Drug product (tablets) manufacturer (compression, coating, packaging into bottles/blisters)
- Quality release testing and batch release (GxP release under Genentech/Roche QA)
- Distribution and wholesaling (US distribution partners feeding pharmacies/IDNs)
Publicly accessible data most often identifies the labeler and release/manufacturing sites at a facility level via FDA/EMA documentation rather than naming each upstream raw-material vendor.
What are the listed manufacturers and drug product facilities for COTELLIC?
Answer: FDA labeling and related registrations generally identify the finished dose manufacturing sites as part of the manufacturing description, while the specific API site(s) are usually captured in FDA drug master file linkages and/or facility-level registrations rather than in the marketing label text.
What to expect in FDA registration and listing sources?
For COTELLIC, the supplier picture in public sources typically breaks out into:
- NDC-labeled finished product manufacturers (site-level)
- Contract manufacturing organization (CMO) sites for tablets and packaging
- API sites listed through drug substance manufacturing registrations and/or DMF-based references
What does “suppliers for COTELLIC” mean for licensing and procurement?
When business teams ask “suppliers,” they usually mean one (or more) of these:
- Who can make cobimetinib fumarate API to GMP standards suitable for US submission
- Who can manufacture and package the tablets at scale
- Which facilities are tied to regulatory commitments (inspection history and filing support)
- Which sites are risk-sensitive (single-source bottlenecks, coating/packaging constraints)
Those details are typically derived from:
- FDA facility registrations and inspections
- Orange Book and FDA labeling cross-references to manufacturing descriptions
- DMF-linked API supplier documentation (not always public in full)
Which suppliers can make cobimetinib fumarate API?
Answer: Cobimetinib fumarate API supply is dominated by Roche/Genentech’s global API manufacturing network and qualified CDMOs under Roche governance. Public sources most reliably confirm labeler ownership (Genentech) but may not name every upstream API vendor in consumer-facing materials.
What API quality and regulatory requirements constrain supplier qualification?
- GMP control for cobimetinib fumarate polymorph/impurities
- Compliance with ICH Q3A/Q3B impurity profiles
- Traceability of synthetic intermediates used to produce cobimetinib
- Stability-aligned specs supporting shelf life for the tablets
What procurement risk appears for unique kinase inhibitor APIs?
Kinase inhibitor APIs often create supply risk through:
- A limited number of intermediates supply chains
- Specialized purification and crystallization steps
- DMF dependency and validation turnaround for alternate suppliers
Who makes and packages COTELLIC tablets (finished dosage form)?
Answer: COTELLIC is manufactured as cobimetinib tablets in Roche/Genentech’s global tablet facilities and/or qualified CMOs, with finished product release under Genentech’s quality system and distribution in the US through standard wholesalers.
What manufacturing steps define the tablet supplier set?
Key tablet manufacturing unit operations that drive CMO qualification include:
- Blending and direct compression or granulation route (as per registered process)
- Film coating and tablet appearance specs
- Desiccant and bottle packaging controls (or blister controls)
- End-to-end stability and packaging compatibility testing
Is there any generic or biosimilar competition that changes “supplier” mapping?
Answer: COTELLIC is a small-molecule targeted therapy. “Supplier” mapping does not shift in the same way as with biologics, where biosimilars create additional parallel drug-substance makers. In small molecule markets, the supplier set expands when generics enter, not via pathway comparability.
What to check for competition-driven supplier diversification?
- Orange Book listings for COTELLIC (proprietary status and any ANDA approvals)
- FDA drug product and applicant manufacturing site changes over time
How to use COTELLIC supplier data for licensing or litigation?
Answer: Supplier identification matters in three ways: (1) verifying whether a challenger can source API and drug product under GMP, (2) aligning on facility-level regulatory history, and (3) building an evidentiary chain for IP and regulatory strategy.
Typical deal and litigation questions tied to suppliers
- Can an alternative manufacturer support ANDA/505(b)(2) chemistry equivalence without process change?
- Are there manufacturing steps or specs tied to patent-protected formulation/process?
- Does a facility have a history of compliance issues or capacity constraints?
Supplier landscape: what matters commercially for COTELLIC?
Answer: The commercially relevant supplier set for COTELLIC is the set of GMP-qualified facilities that can produce:
- cobimetinib fumarate API to registered specs
- tablets meeting dissolution, impurity, and stability profiles
- packaging (bottles/blisters) meeting label and storage requirements
In practice, these supplier choices stay concentrated under Roche/Genentech unless:
- capacity expansion triggers new CMOs
- post-exclusivity competition changes demand structure
Key Takeaways
- Genentech USA, Inc. is the US-facing entity tied to COTELLIC supply and commercialization.
- The upstream “supplier” set for COTELLIC typically sits inside Roche/Genentech’s global manufacturing network and qualified CMOs under Roche governance.
- Supplier due diligence should focus on API maker capability, tablet manufacturing and packaging facility qualification, and facility-level regulatory history, not only the labeler name.
- For licensing and litigation, supplier identification supports assessments of feasibility, timeline risk, and regulatory defensibility.
FAQs
- Who is the labeler/manufacturer on COTELLIC US product packaging?
- Are cobimetinib fumarate API suppliers publicly named in FDA databases?
- How many GMP tablet manufacturing sites typically support a branded small-molecule like COTELLIC?
- Does COTELLIC use contract manufacturing for tablets or does Roche make in-house?
- How can supplier facility data be used to evaluate generic launch readiness for cobimetinib?
References (APA)
- Genentech USA, Inc. COTELLIC (cobimetinib) prescribing information. US FDA label.
- US Food and Drug Administration. Drug product manufacturing and listing databases (NDC labeling, facility registrations, and related public records).
- European Medicines Agency. COTELLIC product information (summary of product characteristics and regulatory documentation).
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