Suppliers and packagers for generic pharmaceutical drug: Venetoclax

Venetoclax

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	VENCLEXTA	venetoclax	TABLET;ORAL	208573	NDA	AbbVie Inc.	0074-0561-11	1 BLISTER PACK in 1 CARTON (0074-0561-11) / 2 TABLET, FILM COATED in 1 BLISTER PACK	2016-04-11
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573	NDA	AbbVie Inc.	0074-0561-14	1 BLISTER PACK in 1 CARTON (0074-0561-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK	2016-04-11
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573	NDA	AbbVie Inc.	0074-0566-07	1 BLISTER PACK in 1 CARTON (0074-0566-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK	2016-04-11

Suppliers and packagers for generic pharmaceutical drug: Venetoclax

Last updated: June 2, 2026

VENETOCLAX suppliers and manufacturing: Who makes the API, tablets, and key components?

Venetoclax supply chains split into (1) active pharmaceutical ingredient (API) manufacturing, (2) finished-dose tablet production and packaging, and (3) critical starting materials and intermediates that drive cost and schedule risk. Publicly available supplier identifiers are concentrated around the US FDA’s drug master files, Orange Book listings, and company disclosures in regulatory filings and procurement-facing documents.

Who supplies venetoclax API (active pharmaceutical ingredient) and who manufactures tablets?

Direct API and finished-dose manufacturing identities for venetoclax are primarily determined by:

1. Orange Book “Applicant/Manufacturer” and listed manufacturing sites for each marketed NDA product.
2. Drug Master File (DMF) owners for key starting materials and manufacturing steps.
3. Corporate disclosures in annual reports, investor decks, and regulatory correspondence that name CMOs/CDMOs used for scale-up.

Market reality for venetoclax supply

• Venetoclax is a niche, high-value oncology small molecule with limited reliable small-molecule CDMO capacity for complex synthesis and controlled crystallization steps.
• Supply risk concentrates in specific intermediates and in finished-dose batch release capacity tied to NDA-specific specs.

What API is and isn’t “supplied” in venetoclax procurement?

• API is sold under controlled quality systems, often sourced through a mix of:
  • API manufacturers with direct commercial supply contracts
  • “virtual” procurement via distributor networks where the end-manufacturer is the NDA’s listed API source
• Intermediates and key starting materials may be sourced separately and then used by the API site.

What is the Orange Book status of venetoclax and which manufacturers are listed for US supply?

Orange Book “manufacturer/applicant” listings are the most operationally useful supplier map because they tie:

• the marketed strength/formulation
• to the applicant
• to the US-manufacturing or release site(s) listed for that product configuration.

For supplier planning, the key deliverable is a table that matches:

• dosage form/strength
• Orange Book product code
• applicant/holder
• listed manufacturing/release facilities

Which product labels determine the real-world supplier?

Venetoclax is marketed as tablets. Supplier identification should be done at the product configuration level, because:

• multiple strengths can have different manufacturing lots and sometimes different site release paths
• post-approval scale changes can shift manufacturing sites without changing the core NDA holder

Which companies are the likely suppliers for venetoclax tablets in the US market?

In practice, US tablet supply is typically handled by:

• the NDA holder’s internal manufacturing network and/or
• contracted CMO/CDMO facilities responsible for tablet compression, coating, blending, drying, and packaging, under GMP release responsibility.

For business users, the supplier shortlist is built from Orange Book site listings plus facility names in:

• FDA inspection histories
• DMF links
• NDA supplements naming manufacturing changes

How to convert regulatory listings into a procurement-ready supplier map

A usable supplier map must separate:

• tablet manufacturing sites (compression/coating/packaging)
• API manufacturing sites
• release and QC sites (often different addresses)

What patents protect venetoclax manufacturing and how does that affect sourcing?

Patent protection affects supply by restricting:

• synthesis routes
• key intermediates
• crystallization/polymorph control
• solid-state forms relevant to bioavailability
• scale-up and manufacturing methods

Do manufacturing-process patents block generic or “second-source” API?

Where process patents remain in force, “second-source” API may require:

• different routes that avoid claim coverage
• licensing from patent holders
• design-around with demonstrable non-infringement and comparable quality

For venetoclax, supplier changes are most likely when:

• route-specific patents expire or narrow
• non-infringing synthesis is validated
• the supply chain has cleared comparability and NDA tech transfer gates

What generic entry risks exist for venetoclax and how does that change the supplier landscape?

Venetoclax’s entry risk depends on:

• whether ANDA submissions target a later-dated paragraph IV path
• whether patents listed in the Orange Book and related method-of-use patents remain enforceable
• whether formulation and process patents limit the ability to source alternative API

Biosimilar risk

Venetoclax is a small molecule, so biosimilar frameworks do not apply. Competitive entry risks are from ANDAs (generics) and potentially authorized generics.

How many venetoclax suppliers exist and what are the key bottlenecks?

A reliable count requires enumerating the Orange Book manufacturing site list and DMF owners tied to the marketed NDA. Bottlenecks usually include:

• limited qualified sites for complex small-molecule synthesis
• controlled polymorph/crystal form control steps in API
• tablet film-coating and dissolution specification compliance

Bottleneck categories used in sourcing decisions

• API step complexity: number of isolations, purification steps, solvent control
• solid-state control: polymorph/conversion risk
• scale risk: yield and impurity profile sensitivity
• QC capacity: release testing throughput and method transfer

What does the venetoclax supply chain look like by step (API to tablet)?

A high-level step map for procurement and regulatory diligence:

1. Key starting material sourcing
   Impacts lead time and impurity risk.
2. API synthesis and purification
   Drives DMF registration and site qualification.
3. API solid-state processing
   Includes crystallization and drying controls.
4. Tablet blending, granulation, compression
   Needs consistent particle size distribution and flow properties.
5. Film coating and drying
   Controls dissolution and tablet appearance specs.
6. Packaging and labeling
   Requires correct dose-counting and stability packaging.
7. GMP release and distribution
   Ties back to the NDA-specific release site.

What litigation or settlements affect venetoclax sourcing or new manufacturing routes?

Patent litigation can cause:

• delayed generic approvals
• enforced injunction risk around manufacturing methods
• licensing terms that shape “who can supply” alternative APIs

A complete litigation impact view requires a docket-linked mapping from:

• asserted patents
• paragraph IV filings (if any)
• settlement dates and terms affecting entry timing

Key Takeaways

• Supplier identification for venetoclax should start with Orange Book applicant/manufacturer listings at the tablet product level, then map to DMF owners for API and critical intermediates.
• Procurement risk concentrates in API synthesis and solid-state control, not only in tablet manufacturing capacity.
• Patent protection tied to manufacturing methods and forms can limit feasible second sources and slow onboarding of alternative API sites.
• Competitive supply expansion depends on generic entry status, paragraph IV outcomes, and whether manufacturing-process claims constrain non-infringing route options.

FAQs

Who makes venetoclax tablets for US distribution?

Use the Orange Book listing for the marketed tablet strengths to identify the applicant and listed manufacturing/release sites.

Who owns the DMFs for venetoclax API or key intermediates?

DMF ownership is identified through DMF submissions referenced by the NDA and can be matched to API/intermediate manufacturing steps.

Can a CDMO supply venetoclax API under a different synthesis route?

Only if the route avoids applicable method-of-manufacture claims and meets NDA-approved quality attributes and comparability requirements.

What solid-state form risks affect venetoclax supply?

Polymorph/crystal form control affects dissolution and stability and can constrain which API sites can qualify without new validation.

What regulatory steps must be completed to add a new venetoclax manufacturing site?

NDA supplements or site change notifications with updated chemistry, manufacturing, and controls (CMC) evidence are required, plus GMP readiness and release method alignment.

References (APA)

1. FDA. (n.d.). Drugs@FDA: Venetoclax. U.S. Food and Drug Administration.
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Venetoclax). U.S. Food and Drug Administration.
3. FDA. (n.d.). Drug Master Files (DMF). U.S. Food and Drug Administration.