Suppliers and packagers for KYBELLA

KYBELLA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333	NDA	Kythera Biopharmaceuticals Inc.	61168-101-03	2 VIAL, GLASS in 1 CARTON (61168-101-03) / 2 mL in 1 VIAL, GLASS	2015-06-08
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333	NDA	Kythera Biopharmaceuticals Inc.	61168-101-04	4 VIAL, GLASS in 1 CARTON (61168-101-04) / 2 mL in 1 VIAL, GLASS (61168-101-01)	2015-06-08

Kybella (deoxycholic acid) Suppliers: Who Manufactures the Drug Substance, Product, and Key Inputs

Last updated: May 27, 2026

Kybella’s supply chain is split between (1) deoxycholic acid (DCA) drug substance manufacture, (2) finished-dose product manufacture and packaging for intralesional injection, and (3) downstream contract manufacturing and distribution. The most decision-relevant view for sourcing, licensing, and launch-risk work is the identity of the companies listed on Kybella’s FDA label and the manufacturing sites tied to the approved NDA.

Who supplies Kybella (deoxycholic acid) injection in the US?

Answer: Kybella (deoxycholic acid) 10 mg/mL is marketed in the US under Allergan (AbbVie) sponsorship, and is manufactured/filled at FDA-registered sites associated with the approved marketing application. The practical “supplier” list for commercial planning is: the NDA holder (marketing authorization holder), the contract manufacturer(s) tied to the approved product, and the distributor network.

NDA holder and label accountability

• Marketing authorization holder (US): Allergan, an AbbVie company (brand owner and NDA holder for Kybella in the US).
• Supplier-type implication: Contract manufacturing is typically performed by one or more third parties and may change over time, but the NDA holder remains the responsible label entity for quality system oversight, supply continuity, and CMC comparability.

What companies manufacture the finished Kybella drug product?

Answer: The finished product (deoxycholic acid injection) is produced and packaged by the FDA-registered manufacturer(s) named on the Kybella label/FDA approval record. These sites define the actionable sourcing options for CDMO qualification, supply continuity due diligence, and regulatory transfer risk.

How to map “supplier” to FDA reality

For Kybella, the supplier question has three distinct regulatory objects:

1. Drug substance site(s) for DCA synthesis and purification.
2. Drug product site(s) for sterile formulation, filling, and assembly.
3. Distribution and wholesaling through approved channels (often multiple).

For high-stakes sourcing, the only defensible supplier list is the one anchored to FDA-registered manufacturing sites supporting the approved NDA and the current label.

What suppliers provide the deoxycholic acid (DCA) drug substance?

Answer: DCA suppliers in pharma supply chains are typically specialized chemical manufacturers producing bile-acid derivatives to pharma standards. The exact DCA supplier identities for Kybella depend on the drug substance section of the NDA approval record and the current manufacturing arrangement disclosed through FDA CMC documentation and label-referenced sources.

DCA sourcing risk drivers

• Single-site vs multi-site DCA supply affects lead times and outage risk.
• Change-control history (comparability, bridging, stability) affects transfer feasibility.
• Sterile drug product integration raises downstream constraints even if DCA API is available.

Where is Kybella filled and packaged for injection?

Answer: Kybella is a sterile injectable. The relevant “supplier” entities are the sterile fill-finish and packaging manufacturers listed for the approved product. These manufacturers are the gating items for:

• alternative sourcing contracts,
• manufacturing site qualification for a parallel product,
• and any “same active, different label” comparison work.

Sterile fill-finish requirements that constrain suppliers

• Sterility assurance and aseptic processing validation
• Container-closure integrity for injection
• Batch release testing for potency and impurities
• Controlled storage and cold-chain or stability-aligned handling (as specified in labeling/CMC)

Which CDMOs or contract manufacturers have produced Kybella?

Answer: Kybella’s contract manufacturing and packaging entities are defined by the FDA-registered sites tied to the NDA. The market-facing “supplier” answer is: the registered drug product manufacturer(s) shown for Kybella’s approval and the fill-finish sites used by the NDA holder.

Why CDMO identity matters

• If you are underwriting supply availability or licensing manufacturing rights, the legal and regulatory burden sits at the NDA holder and the registered manufacturer.
• If you are building a generic/similar injection, fill-finish site transfer is a major CMC and validation cost center.

How do you identify Kybella suppliers quickly for diligence?

Answer: Use three linked FDA records:

1. Current US label (manufacturer/packager language)
2. FDA application/manufacturer listings tied to the approved NDA
3. FDA inspection and registration databases for the specific manufacturing site(s) supporting the finished product

This triangulation produces a defensible supplier list for vendor onboarding, litigation discovery prep, and continuity planning.

Supplier landscape: how many entities are typically in the Kybella supply chain?

Answer: Kybella supply chains usually involve multiple entities:

• One NDA holder/brand owner (Allergan/AbbVie)
• One or more drug product manufacturing/sterile fill-finish sites
• One or more drug substance producers for DCA
• One or more distribution partners

The number and identity of each category depends on the current CMC configuration for the specific NDA strength and dosage form (Kybella is an injectable).

What supplier changes affect Kybella availability?

Answer: Availability risk typically tracks:

• drug substance supply disruptions for DCA,
• sterile fill-finish capacity constraints,
• packaging component shortages (vials, stoppers, seals),
• and regulatory/quality events that lead to batch hold or recall.

Key Takeaways

• “Supplier” for Kybella should be mapped to FDA-linked entities: NDA holder plus the FDA-registered drug substance and drug product manufacturers.
• The actionable list for diligence is the current label and FDA-registered manufacturing sites, not general “API market” estimates.
• DCA API sourcing and sterile fill-finish capacity are the two supply-chain bottlenecks that most directly impact continuity for Kybella injections.

FAQs

1) Who is the manufacturer listed on the Kybella prescribing information?

The prescribing information names the NDA holder and provides manufacturer/packager language tied to the approved product. That label language is the primary starting point for identifying the responsible manufacturing entities.

2) Can a new supplier qualify to make Kybella’s deoxycholic acid injection?

A new supplier requires regulatory CMC comparability or a manufacturing site transfer under the NDA holder’s change control, with sterile manufacture qualification and batch release alignment.

3) What is the most supply-sensitive component for Kybella?

DCA drug substance availability and sterile fill-finish capacity are typically the highest-sensitivity elements.

4) Do Kybella generics require the same suppliers?

Generic approvals depend on FDA regulatory requirements for manufacturing and bioequivalence or clinical requirements where applicable, but they do not require the brand’s same suppliers. They must meet product quality and CMC requirements under their own approved application.

5) What data sources reveal Kybella’s manufacturing sites?

The most direct sources are the approved NDA-linked FDA records and the manufacturer/packager fields in the current US label, supported by FDA registration/inspection databases for specific facilities.

References

1. FDA. Kybella (deoxycholic acid) prescribing information and label details. US FDA drug label database.
2. FDA. Orange Book and NDA record for Kybella (deoxycholic acid). US FDA.
3. FDA. Drugs@FDA application and approval records for Kybella. US FDA.