Suppliers and packagers for NINTEDANIB ESYLATE

NINTEDANIB ESYLATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	NINTEDANIB ESYLATE	nintedanib esylate	CAPSULE;ORAL	219227	ANDA	Apotex Corp.	60505-4818-6	1 BOTTLE in 1 CARTON (60505-4818-6) / 60 CAPSULE in 1 BOTTLE	2026-04-02
Apotex	NINTEDANIB ESYLATE	nintedanib esylate	CAPSULE;ORAL	219227	ANDA	Apotex Corp.	60505-4819-6	1 BOTTLE in 1 CARTON (60505-4819-6) / 60 CAPSULE in 1 BOTTLE	2026-04-02
Cipla	NINTEDANIB ESYLATE	nintedanib esylate	CAPSULE;ORAL	212609	ANDA	Cipla USA Inc.	69097-639-03	60 CAPSULE in 1 BOTTLE (69097-639-03)	2026-04-02
Cipla	NINTEDANIB ESYLATE	nintedanib esylate	CAPSULE;ORAL	212609	ANDA	Cipla USA Inc.	69097-641-03	60 CAPSULE in 1 BOTTLE (69097-641-03)	2026-04-02

Suppliers and packagers for NINTEDANIB ESYLATE

Last updated: June 22, 2026

Nintedanib Esylate Suppliers: Who Makes the API, Drug Substance, and Key Excipients?

Nintedanib esylate supply is typically split across (1) API and key intermediates producers for the drug substance and (2) finished-dose manufacturers for soft gelatin capsules. Supply-chain risk is concentrated in drug-substance capabilities because nintedanib synthesis relies on controlled intermediates and tight impurity specs under NDA/ANDA and cGMP change-control.

Who supplies nintedanib esylate API and drug substance?

Nintedanib esylate drug substance is supplied by a limited set of specialized API and intermediate manufacturers that can support originator-grade impurity profiles and regulatory documentation for marketed product lots.

Common supplier roles across the nintedanib chain

• API manufacturer (nintedanib free base and conversion to nintedanib esylate as drug substance)
• Intermediate manufacturers supporting the synthetic route (key chirality and/or heterocycle-forming steps, depending on the route used)
• Drug-substance packagers and release testing sites (analytical method availability and impurity quantitation)
• Finished-dose contract manufacturers for soft gelatin capsules (if not produced in-house by the brand)

How to identify the API supplier in practice

For US commercialization, API sourcing is usually evidenced through:

• DMFs referenced in FDA submissions for the listed product(s)
• Orange Book-linked manufacturing and submission details for the approved label (for direct manufacturing sites)
• cGMP inspection footprints by manufacturing site addresses

However, “supplier” names are not reliably enumerated by a single public index for all branded and unbranded lots, so supplier lists are often incomplete unless triangulated with DMF and FDA submission content.

Which companies manufacture Ofev (nintedanib) soft gelatin capsules?

Ofev is the reference branded product using nintedanib as the active ingredient. Soft gelatin capsule manufacturing is generally handled by one or more contract manufacturing organizations plus in-house sites depending on packaging scale and regional distribution.

Finished-dose supply structure

• Soft-gel capsule manufacturing site(s) for capsule filling and sealing
• Bulk drug product manufacturing site(s) for dispersion/powder preparation into filled shells
• Primary packaging sites for blistering or bottle filling, plus labeling and distribution packaging

Why finished-dose suppliers matter

Even if multiple API vendors exist, finished-dose bottlenecks often come from:

• Specific soft-gel formulation process knowledge
• Cross-site validated dissolution and content-uniformity methods
• Capsule shell material sourcing and compliance with change-control

What suppliers support nintedanib esylate intermediates and key starting materials?

Intermediate supply is a practical control point because API quality depends on limiting specific genotoxic/impurity-forming steps.

Intermediate risk points typically controlled

• High-purity heterocycle and coupling intermediates
• Steps that introduce process-related impurities that are monitored as specific impurity markers in release specs
• Conversion steps that may require salt formation consistency for nintedanib esylate

Supplier diversification strategy

Brand and generic manufacturers typically qualify at least one backup intermediate or API route supplier to manage:

• Capacity shortfalls
• Raw-material lead times
• Regulatory and stability data alignment

Are there multiple nintedanib esylate suppliers for generics and biosimilars?

Nintedanib is a small-molecule drug, so the market deals with:

• Generic manufacturers (ANDA)
• Authorized generics or contract manufacturing arrangements
• Not biosimilars, since biosimilars apply to biologics

Generic and authorized-generic supply chains can include additional API suppliers compared with a single originator pathway, but the same cGMP-quality constraints apply.

What patent and regulatory status affects nintedanib esylate supplier qualification timelines?

Supplier qualification depends on:

• Product exclusivity and patent posture at the brand level
• Whether a generic is pursuing FDA approval before or after relevant exclusivity/patent windows
• DMF reliance and method transfer timelines

If generic entry proceeds, API qualification and drug-product method validation are required ahead of launch.

How does API DMF status determine which suppliers can sell nintedanib esylate?

Drug Master Files (DMFs) enable reliance by applicants. In practice:

• A supplier with a DMF can more easily support approved ANDA submissions
• A supplier without a relevant DMF face longer dossier build and method validation

So the most actionable supplier set is the set of API vendors with DMF-referenced quality systems and specs.

What are the main manufacturing bottlenecks in nintedanib esylate supply?

Bottlenecks typically cluster around:

• API impurity control and analytical method capability
• Salt formation and crystallization consistency for nintedanib esylate
• Soft-gel capsule process control for uniform drug loading and dissolution performance

Supply disruptions tend to trace to:

• Limited capacity at a few API sites
• Raw-material interruptions for intermediate synthesis
• Capsule-shell supplier constraints

Key Takeaways

• Nintedanib esylate supply is concentrated in specialized API drug-substance and soft-gel finished-dose manufacturing sites with the capacity to meet tight impurity and dissolution specs.
• Practical “who supplies” answers depend on triangulating FDA/Orange Book-linked manufacturing sites and DMFs; single-source public lists are typically incomplete.
• The largest supply-chain risks are drug-substance impurity control, salt formation reproducibility for the esylate form, and soft-gel capsule process validation.

FAQs

1) Are nintedanib esylate and nintedanib free base interchangeable for sourcing?

No. Drug substance salt form affects crystallinity, impurity profile targets, and specification acceptance under cGMP. Suppliers must match the salt form used in the approved drug substance/control strategy.

2) Do API suppliers of nintedanib also supply intermediates to finished-dose manufacturers?

Often intermediates are supplied separately by different qualified vendors. Finished-dose manufacturers typically procure either API directly or API plus key intermediates under separate qualification packages.

3) Can a generic manufacturer use a different nintedanib esylate API supplier than the originator?

Yes, subject to ANDA comparability requirements, impurity controls, and validation of drug-substance and drug-product performance. Regulatory filing strategy frequently dictates timing and reliance on DMFs.

4) What certifications and quality systems matter most when qualifying nintedanib esylate suppliers?

cGMP compliance, batch traceability, validated analytical methods for specific impurities, stability program alignment, and change-control history for salt formation and crystallization steps.

5) Is there any supply difference between US and EU nintedanib esylate sourcing?

Often yes due to different approved manufacturing site networks, distribution agreements, and regional packaging and labeling requirements. The core API and capsule manufacturing constraints remain similar.

References

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