Suppliers and packagers for QBRELIS

QBRELIS

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401	NDA	Azurity Pharmaceuticals, Inc.	52652-3001-1	150 mL in 1 BOTTLE (52652-3001-1)	2016-08-29

Qbrelis (trilaciclib) suppliers: who manufactures the drug substance, drug product, and key components?

Last updated: June 2, 2026

Executive summary

• Qbrelis is supplied through a commercial supply chain built around the sponsor’s labeled product and its registered manufacturing sites for drug substance and finished dosage forms.
• The actionable supplier map is the set of GMP drug substance and drug product manufacturing facilities listed in FDA submissions and referenced in labeling/approvals for Qbrelis.
• Without the specific “Qbrelis” strength and formulation (and without the FDA approval listing or NDA/ANDA product listing record), a complete, accurate supplier roster (site-by-site, company-by-company) cannot be produced.

What suppliers make Qbrelis (trilaciclib) drug substance and drug product?

A complete supplier answer requires identifying the registered GMP sites for:

• Drug substance manufacturing (active pharmaceutical ingredient, API)
• Drug product manufacturing (finished tablets/capsules, as applicable)
• Sterile vs non-sterile steps (if relevant)
• Packaging and release testing sites (secondary suppliers)

Featured snippet answer: Qbrelis supplier identification is determined by FDA-registered manufacturing sites for the approved NDA label. Those sites are the authoritative source for who makes the API and who makes the finished product.

How to identify the official Qbrelis manufacturing suppliers

For a given strength and dosage form, the supplier list is taken from:

• The FDA “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) listing for Qbrelis (drug product manufacturers and application holder)
• The FDA Drugs@FDA approval package and labeling sections that name manufacturing sites
• Drug master file (DMF) references for API manufacturing (when disclosed in the approval record)

Who is listed as the application holder and manufacturer of Qbrelis in FDA records?

The application holder and the drug product manufacturer can differ:

• Sponsor or license holder (application holder)
• Contract manufacturing organization (CMO) for drug product
• API CMO under DMF or cross-reference arrangements

Featured snippet answer: The application holder is shown in FDA approval and Orange Book records; the drug product manufacturing sites are shown under the “Manufacturer” entries for the specific Qbrelis product code/strength.

Which companies supply Qbrelis tablets or capsules (dosage form by strength)?

Qbrelis supplier mapping is dosage-form specific. The supplier roster must match:

• Strength (mg)
• Dosage form (tablet vs capsule vs other)
• Route of administration
• Market package configuration (bottle/blister)

Featured snippet answer: The supplier list changes when FDA lists different strengths or package configurations under the same branded name, because each product listing can map to different manufacturing sites.

How strong is the Qbrelis supply chain: single-source vs multi-source manufacturing?

Supply-chain risk is assessed by whether FDA lists:

• One drug product manufacturing site vs multiple
• One API source vs multiple DMFs
• Backup CMOs that appear in supplement approvals

Featured snippet answer: If multiple manufacturing sites are listed across supplements, Qbrelis has a broader supply base; if only one site is listed, it is closer to single-source risk.

What to look for in FDA supplements

For supplier changes, watch for:

• Manufacturing site change supplements
• Scale-up or tech transfer supplements
• Packaging change supplements
• Stability or testing site changes

What generic or biosimilar risk affects Qbrelis supply availability?

This depends on whether Qbrelis is:

• Small-molecule chemically synthesized drug (generic pathway) or
• Biologic (biosimilar pathway)

Featured snippet answer: If Qbrelis is small-molecule, supplier constraints are more tied to API manufacturing and contract capacity; if it is a biologic, supply risk concentrates around DS and DP fill-finish capacity and cold-chain.

What raw-material and intermediate suppliers matter for Qbrelis production?

Raw-material supplier identification is typically not fully public at the “vendor of record” level. Publicly available disclosures usually stop at:

• API manufacturing site (company/site)
• Finished dose manufacturing site (company/site)
• DMF holders if referenced in public FDA documents

Featured snippet answer: The public “supplier” view for Qbrelis is the registered manufacturing facilities for API and drug product, not a complete list of upstream chemical intermediates.

What contract manufacturers (CMOs) make Qbrelis under agreement?

CMO identification is done by matching:

• FDA labeling manufacturing addresses
• Orange Book “Manufacturer” entries
• Sponsor’s manufacturing section in the label

Featured snippet answer: The CMOs are the companies tied to the FDA-listed drug product manufacturing sites for each Qbrelis strength.

Which Qbrelis packaging suppliers are used (blister vs bottle)?

Packaging suppliers are not always listed as separate vendors in FDA public materials. When they are disclosed, it is via:

• Label packaging sections
• Manufacturing and control site addresses
• Supplement documents for packaging configuration changes

Featured snippet answer: Packaging vendor identification, if disclosed, is tied to FDA-listed packaging and labeling operations for the specific product.

Key Takeaways

• Qbrelis “suppliers” in a defensible business sense are the FDA-registered drug substance and drug product manufacturing sites for the approved strength and dosage form.
• Orange Book and Drugs@FDA are the authoritative public anchors for the supplier roster.
• Upstream raw-material and intermediate vendor lists are rarely fully disclosed publicly.

FAQs

1) Where can I find the official Qbrelis manufacturing sites?
From the FDA Orange Book listing and Drugs@FDA approval package for Qbrelis, mapped to the specific strength and dosage form.

2) Are Qbrelis drug substance and drug product manufactured by the same company?
They can be, but supply chain structure varies by strength and by supplement history; the FDA-listed sites determine the answer.

3) Can Qbrelis switch suppliers without public notice?
Changes are typically implemented via FDA supplement approvals when manufacturing sites or processes change.

4) Do Qbrelis packaging suppliers appear in FDA listings?
Sometimes, via packaging and labeling operation addresses in the approval package or label; not always as named vendor companies.

5) Does the Qbrelis supplier list differ by strength?
Yes. FDA listings can assign different manufacturing sites per strength or package configuration.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drugs@FDA: FDA-Approved Drugs. U.S. Food and Drug Administration.