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Suppliers and packagers for generic pharmaceutical drug: TRILACICLIB DIHYDROCHLORIDE
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TRILACICLIB DIHYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacosmos | COSELA | trilaciclib dihydrochloride | POWDER;INTRAVENOUS | 214200 | NDA | G1 Therapeutics, Inc. | 73462-101-01 | 1 VIAL, GLASS in 1 CARTON (73462-101-01) / 20 mL in 1 VIAL, GLASS | 2021-02-12 |
| Pharmacosmos | COSELA | trilaciclib dihydrochloride | POWDER;INTRAVENOUS | 214200 | NDA | Pharmacosmos Therapeutics Inc. | 73594-0101-1 | 1 VIAL, GLASS in 1 CARTON (73594-0101-1) / 20 mL in 1 VIAL, GLASS | 2025-08-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Trilaciclib Dihydrochloride Suppliers: What Companies Provide Drug Substance, Finished Dosage Forms, and Key Supply-Chain Components
Executive summary: Trilaciclib dihydrochloride is supplied through a small, tightly controlled network tied to its global clinical and commercial manufacturing. Publicly disclosed supplier data is limited, but the supply chain is anchored by the drug’s original manufacturer/marketer and its contracted commercial manufacturing partners. No complete, reliable list of all drug-substance and drug-product suppliers can be produced from public records available in the cited sources below.
Who are the trilaciclib dihydrochloride suppliers for drug substance and finished product?
Answer (from public records): The most dependable public supplier identification comes from the marketing authorization and US FDA approval footprint for trilaciclib, which points to the original NDA holder and its manufacturing network. Exact third-party supplier identities for active pharmaceutical ingredient (API) and finished dosage form (FDF) are typically controlled via confidentiality in manufacturing agreements and are not fully enumerated in public-facing FDA documents.
US commercialization anchor
Trilaciclib (brand: Cosela) is distributed in the US by G1 Therapeutics, Inc. (the NDA holder). Supply-chain partners for manufacturing are generally reflected in FDA chemistry and manufacturing details, but these are not published as a comprehensive “suppliers list” in the public-facing materials typically used for commercial procurement.
Global market authorization footprint
Across major jurisdictions, trilaciclib’s approved manufacturing sites are listed in regulatory submissions and marketing authorization dossiers, with site-level granularity often available, while upstream API sourcing is not always exposed in a way that enables a complete “supplier roster” for procurement.
Which contract manufacturing organizations (CMOs) make trilaciclib drug product?
Answer (from public records): Public information tends to provide manufacturing site names rather than a procurement-ready list of all CMOs and subcontractors involved in drug product release. For trilaciclib, site disclosure exists at the level of authorized manufacturing facilities, but a consolidated list of every CMO tier is not fully reconstructible from available public extracts.
Drug product manufacturing scope that typically affects supplier selection
For procurement due diligence, the key categories are usually:
- Finished-dose manufacturing (dosage form manufacturing, packaging, labeling)
- Release and quality testing (in-process, stability programs, QC batch release)
- Stability and packaging supply chain (primary packaging components, cold chain if applicable)
- Regulatory release testing (method validation and specification controls)
Public supplier identification that is procurement-actionable typically requires dossier-level manufacturing disclosures that are not fully reproduced in public sources.
What is the API supplier landscape for trilaciclib dihydrochloride?
Answer (from public records): Trilaciclib dihydrochloride’s API sourcing is not fully enumerated publicly. API manufacturing is commonly controlled through:
- Controlled-feasibility processes
- Restricted intermediates
- Proprietary polymorph/particle engineering and control strategy
- Contractual restrictions in non-public manufacturing agreements
What procurement teams should map anyway
Even when the “supplier list” is incomplete, effective due diligence maps:
- API site of manufacture (authorized manufacturing facility)
- API solid-state form controls tied to stability and bioavailability
- Impurity profile control (process-related impurities and limits)
- Change control history and comparability protocol outcomes
What Orange Book status exists for trilaciclib and how does it affect supplier access?
Answer (from public records): Trilaciclib is a drug for which FDA listing artifacts (including patents and exclusivity information) affect competitive entry and can indirectly affect supplier dynamics, since API and drug product availability is managed to protect validated commercial manufacturing and patent-protected supply continuity.
Why Orange Book status matters for supplier planning
- If exclusivity/patent protection blocks generic or biosimilar-type substitutions, the supplier base remains dominated by the originator’s validated manufacturing network.
- Patent estate and formulation/method protections often tighten the ability to qualify alternative suppliers without additional regulatory work.
Are there paragraph IV or biosimilar challenges for trilaciclib that change the supplier landscape?
Answer (from public records): Publicly identifying Paragraph IV filings or biosimilar challenges requires review of FDA litigation and patent dispute databases tied to the Orange Book and the relevant NDA approvals. A complete enumeration cannot be produced here from the limited public extracts cited.
How do trilaciclib supplier options differ by geography (US, EU, UK, etc.)?
Answer (from public records): Regulatory authorization is typically site-based. As a result, the supplier set that can legally supply a market is constrained by:
- Authorized manufacturing sites in the marketing authorization
- Batch release jurisdictions
- Importation and distribution authorizations
Procurement options therefore differ materially by region even when the same company controls the network.
What formulations are produced under trilaciclib dihydrochloride supply contracts?
Answer (from public records): Publicly, trilaciclib is known as an injectable regimen (commercially marketed as Cosela). Supplier qualification depends on the exact drug product presentation (strength, vial configuration, packaging format, labeling language, and distribution controls). A fully enumerated supplier-to-formulation mapping requires dossier-level manufacturing disclosure.
How strong is the supply-chain/IP position for trilaciclib dihydrochloride?
Answer (from public records): Supplier access is shaped by:
- Commercial manufacturing validation and change control
- Regulatory expectations for comparability if API process or solid-state changes occur
- Patent-protected aspects that can block or complicate alternate supplier qualification
A complete “strength score” of the supply-chain/IP position cannot be computed here from publicly available data in the cited sources.
Key takeaways
- The most reliable public “supplier” identification for trilaciclib centers on the NDA holder/distributor and the authorized manufacturing sites, not a comprehensive tiered list of all API and drug product suppliers.
- API supplier identities and upstream subcontractors are not consistently exposed in public records in a way that supports a complete procurement roster.
- Supplier availability differs by geography due to authorized manufacturing and batch release constraints.
- Patent and exclusivity status can indirectly stabilize the supplier base by limiting validated alternate supply entry.
FAQs
- Is there a single API supplier for trilaciclib dihydrochloride?
- Which drug product manufacturing sites are authorized for Cosela in the US and EU?
- Can companies supply trilaciclib dihydrochloride under alternative API routes without regulatory re-qualification?
- Do trilaciclib’s patent listings restrict third-party API procurement or labeling/distribution?
- How do regulatory release and import authorization rules constrain alternative suppliers by country?
References (APA)
- US Food and Drug Administration. (n.d.). Cosela (trilaciclib) prescribing information and FDA approval documentation. https://www.accessdata.fda.gov/
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (search portal). https://www.accessdata.fda.gov/scripts/cder/daf/
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