Suppliers and packagers for TRUQAP

TRUQAP

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197	NDA	AstraZeneca Pharmaceuticals LP	0310-9500-01	64 TABLET, FILM COATED in 1 BOTTLE (0310-9500-01)	2023-11-16
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197	NDA	AstraZeneca Pharmaceuticals LP	0310-9500-02	4 BLISTER PACK in 1 CARTON (0310-9500-02) / 16 TABLET, FILM COATED in 1 BLISTER PACK	2023-11-16
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197	NDA	AstraZeneca Pharmaceuticals LP	0310-9501-01	64 TABLET, FILM COATED in 1 BOTTLE (0310-9501-01)	2023-11-16

Suppliers for TRUQAP (Trilaciclib): manufacturer landscape, CDMO options, and supply-chain IP risks

Last updated: May 26, 2026

TRUQAP (trilaciclib) supply is driven by the original manufacturer listed on FDA product labeling and by the contract manufacturing and packaging network behind the finished dosage form. For sourcing decisions, the highest-yield diligence target is the drug-substance and drug-product manufacturing sites tied to FDA inspections and to the company’s listed facilities in public regulatory records and labeling.

Which companies supply TRUQAP (trilaciclib) and who manufactures the finished drug product?

TRUQAP is marketed in the US under the control of the drug’s sponsor/holder on the FDA label. The practical “supplier” map breaks into three layers: label holder, drug-product (final formulation/packaging) manufacturers, and drug-substance (API) manufacturers.

Supplier identification workflow for TRUQAP

• Step 1: FDA label “Manufactured for” / “Distributed by” and “Manufactured at” statements (fastest route to the labeled finished-dose manufacturer(s)).
• Step 2: Orange Book / FDA databases tied to TRUQAP NDA to connect the listed dosage form and strength to manufacturing sites for batch release.
• Step 3: FDA Establishment Inspection Reports (EIRs) and inspection outcomes linked to those sites to assess continuity risk.
• Step 4: Current GMP capacity and packaging line ownership via corporate filings and CDMO disclosures.

Result

• A complete, defensible supplier list for TRUQAP requires linking the TRUQAP NDA label manufacturer and the actual site(s) named for drug product. No supplier roster can be stated here without specific label and FDA listing data for the exact TRUQAP presentation (strength and dosage form).

What drug-product dosage forms does TRUQAP use and what does that mean for packaging suppliers?

TRUQAP is supplied as a specific injection formulation. Supplier diligence should prioritize:

• Sterile fill-finish and vial/batch packaging capabilities
• Lyophilization vs liquid fill-finish (drives equipment class and lead times)
• Container closure system compatibility and extractables/leachables program
• Cold-chain or ambient stability requirements for distribution

Because “TRUQAP suppliers” typically refers to vial fill-finish and packaging capacity, the supplier set is narrower than the broader API manufacturing set.

What suppliers make trilaciclib (API) for TRUQAP?

Drug-substance supply is the critical bottleneck in oncology injectables when demand steps up. API supplier identification should be based on:

• NDA/label statements for “Active ingredient” manufacture
• FDA inspection records for API sites associated with the NDA
• Public DMF references for trilaciclib (if mapped through FDA databases)

Result

• A specific API supplier list cannot be stated without the TRUQAP NDA drug-substance site data. API manufacturing attribution must be tied to named sites in regulator-facing filings.

How many trilaciclib API suppliers are there and what’s the risk profile?

Supply risk typically increases when:

• There is a single API site with no secondary source qualification
• DMF-reliant manufacturing is not dual-sourced
• API purification steps require specialized reagents with limited vendor options

Conversely, risk reduces when:

• There are at least two qualified API sites with validated comparability
• Packaging and labeling are handled by multiple contract lines
• Quality agreements and tech transfer are in place for rapid scale-up

A defensible count and risk map requires named sites and inspection history.

Who performs CDMO manufacturing for TRUQAP (trilaciclib) and what is the typical contract structure?

For oncology injectables like trilaciclib, the common CDMO structure is:

• API CDMO: synthesis, isolation, purification, and API bulk release testing
• Drug-product CDMO: sterile processing, filling, lyophilization if applicable, labeling, and packaging
• Secondary packaging: cartons, leaflets, and case packing

Result

• A CDMO vendor list for TRUQAP must be anchored to the TRUQAP label’s “manufactured by” and “manufactured for” lines or to FDA listing of manufacturing sites. Without the cited label/FDA data for TRUQAP, vendor names cannot be presented.

Where is TRUQAP manufactured (site locations) and which facilities have regulatory scrutiny?

Site-level scrutiny is where supply decisions get made. The supplier question is inseparable from:

• FDA-483 histories
• consent decrees or import holds
• reinspection outcomes
• sterility assurance program observations

Result

• Site names and inspection outcomes for TRUQAP must be pulled from FDA EIR/inspection reporting for the named manufacturing facilities. No facility list can be provided here without the TRUQAP NDA site identifiers.

How strong are TRUQAP’s manufacturing/IP barriers for generic or biosimilar supply?

TRUQAP is a small molecule. The supply-chain implication is:

• generics can be manufactured if they can meet bioequivalence requirements and regulatory constraints
• manufacturing barriers are mostly about process IP, impurity profile control, and validated process parameters, not “biologic-like” expression systems

Key supplier/IP diligence targets:

• process patents covering API synthesis and purification steps
• formulation patents covering excipients, concentration, pH, buffer system, and fill-finish parameters
• patents covering method-of-use and dosing schedule (relevant to labeling and exclusivity, not to raw supply ability)

Result

• This section requires TRUQAP patent estate details and Orange Book listing mapping, which are not supplied in the prompt.

What generic entry risks exist for TRUQAP that could change supplier dynamics?

Generic entry risks are driven by:

• expiration of listed patents and exclusivity (regulatory exclusivity blocks ANDA approval)
• likelihood of Paragraph IV filings and litigation
• manufacturing readiness lead times for sterile fill-finish

Result

• A TRUQAP generic launch scenario requires Orange Book and litigation timeline data.

Key Takeaways

• TRUQAP supplier identification must start with the FDA label’s listed manufacturing and distribution entities and be validated against FDA listing manufacturing sites.
• “Suppliers” in practice means drug-product (sterile fill-finish/packaging) sites plus the API sites feeding those facilities.
• Site-specific regulatory scrutiny should be evaluated via FDA inspection histories tied to the named manufacturing locations.
• A concrete vendor list for TRUQAP cannot be provided without the underlying FDA label/FDA listing manufacturing-site data for the TRUQAP presentation.

FAQs

Which company is listed on the TRUQAP US label as “manufactured for” or “distributed by”?

Answer: Determined from the specific TRUQAP label package insert for the exact strength and presentation.

What FDA database fields identify TRUQAP manufacturing sites for drug product and API?

Answer: NDA-associated labeling and FDA establishment/manufacturing site listings linked to the TRUQAP drug product and manufacturing establishments.

How do TRUQAP sterile manufacturing requirements affect supplier qualification?

Answer: Qualification focuses on sterile processing controls, aseptic validation, container closure integrity, and sterility assurance testing aligned to the vial/fill-finish format.

Does TRUQAP rely on a single API supplier or multiple qualified sources?

Answer: Confirm by mapping API manufacturing sites tied to the NDA and reviewing whether more than one facility is qualified and inspected for trilaciclib API.

What supply disruptions most commonly threaten TRUQAP availability?

Answer: API supply bottlenecks, sterile fill-finish capacity constraints, and container closure or packaging line shortages at the qualified drug-product site.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. FDA. Prescribing Information for TRUQAP (trilaciclib).
3. FDA. Drug Establishment Inspection Reports (EIR) and inspection information by establishment.