Suppliers and packagers for generic pharmaceutical drug: LAROTRECTINIB SULFATE

LAROTRECTINIB SULFATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-390-01	60 CAPSULE in 1 BOTTLE (50419-390-01)	2019-07-26
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-391-01	60 CAPSULE in 1 BOTTLE (50419-391-01)	2019-07-26
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861	NDA	Loxo Oncology, Inc.	71777-390-01	60 CAPSULE in 1 BOTTLE (71777-390-01)	2018-11-26
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861	NDA	Loxo Oncology, Inc.	71777-391-01	60 CAPSULE in 1 BOTTLE (71777-391-01)	2018-11-26
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-392-01	100 mL in 1 BOTTLE (50419-392-01)	2019-07-26

Larotrectinib Sulfate Suppliers: API, Intermediate, Drug-Product Contract Manufacturing, and Key Supply Chain Risks

Last updated: May 29, 2026

Larotrectinib sulfate supply is concentrated around a limited set of contract manufacturing organizations (CMOs) for small-molecule oncology APIs and solid oral drug products, with additional leverage tied to specialty API intermediate routes and solvent/polymorph control. Procurement diligence should map (1) API vs. drug-product responsibilities, (2) whether suppliers are qualified to commercial lots under the current marketing authorization, and (3) whether any intermediate or final isolation step creates single-source or batch-failure risk.

Which companies supply larotrectinib sulfate API and who manufactures the drug product?

Featured answer: Larotrectinib sulfate is typically supplied through qualified API manufacturers and CMO partners supporting capsule or solution drug product manufacturing. The commercial supply chain is controlled by the marketing authorization holder’s quality agreements and the FDA/EMA-approved manufacturing sites listed in regulatory filings, supplemented by procurement from API intermediates providers where the API step is outsourced.

API supply model for larotrectinib sulfate

Most outsourced small-molecule oncology programs follow a structure where:

• API is produced by an experienced small-molecule chemical manufacturer under GMP.
• Final drug product (tablet/capsule/oral solution) is made by a separate solid-dose CMO.
• Quality and compliance are governed by drug master files (DMFs), Certificates of Analysis (CoAs), and change-control pathways aligned to regulatory submissions.

Drug-product manufacturing typically occurs at a GMP solid-dose site

Larotrectinib sulfate is marketed as an oral dosage form (in US practice, a capsule and an oral solution exist across label evolution). Drug-product suppliers generally include:

• Solids CMOs with scale-up capability for oncology APIs.
• Sites with controlled process capability for low-dose content uniformity and oral liquid fill-finish if an oral solution is part of the label.

What patents or regulatory filings identify the larotrectinib sulfate supplier network?

Featured answer: Supplier identity is usually discoverable through a mix of Orange Book/manufacturer listings (US label), FDA drug registration data, and the manufacturing site disclosures embedded in regulatory submissions and DMFs, with corroboration from GMP inspection records.

What to check in US records

• FDA “Drug Registration and Listing” for each dosage form and NDC
• Orange Book listings for the relevant NDA and reference products
• DMF ownership and cross-references for larotrectinib substance manufacture (where applicable)
• Inspection outcomes linked to manufacturing sites (FDA establishment inspection program disclosures)

What to check in global records

• EMA product information for manufacturing site addresses per dosage form
• National health authority product dossiers where manufacturers are disclosed

Who are the qualified larotrectinib sulfate API manufacturers behind commercial supply?

Featured answer: The qualified supplier list is site-specific and changes by lot, NDA supplement, and comparability protocols. Supplier qualification is constrained by regulatory commitments, change-control limits, and any approved process parameters tied to the master batch record.

Common qualification pathways that affect supplier switching

• Pre-approval manufacturing changes requiring CMC supplement
• Post-approval changes managed under established comparability standards
• Cross-site validation for critical process parameters and impurity profiles
• Stability commitments and re-test expiry assignment per site and packaging

Supply chain bottlenecks to anticipate

• Intermediate availability and impurity-spec control
• Solvent and catalyst supply for key synthetic steps
• Polymorph or hydrate control for sulfate salt formation (where relevant to the validated route)
• Batch release testing capacity for low-level degradants and residual solvents

What contract manufacturing organizations (CMOs) can make larotrectinib sulfate capsules or oral solution?

Featured answer: Solid oral drug product CMOs with validated potency handling, content uniformity control, and controlled blending/granulation are typically the bottleneck-limiting factor rather than general tablet/capsule capability. For oral solution, fill-finish capacity and viscosity/pH compatibility controls matter.

Capsule vs oral solution manufacturing implications

• Capsules: blending uniformity, segregation control, and coating/encapsulation step validation
• Oral solution: formulation stability, preservative system validation (if used), container-closure compatibility, and fill accuracy

Operational criteria buyers should use to screen CMOs

• Proven experience with potent small-molecule oncology APIs
• Dedicated containment and cross-contamination controls
• Analytical method availability for in-process and release testing
• Ability to support regulatory inspections and rapid deviations/CAPA response

How many suppliers exist for larotrectinib sulfate and what is the concentration risk?

Featured answer: Larotrectinib sulfate is generally supported by a limited set of qualified manufacturers, and supply concentration risk is typically driven by:

• limited API intermediate vendors for the specific synthetic route,
• regulatory qualification friction for switching API source, and
• specialized solid-dose or oral liquid fill-finish capacity constraints.

Concentration risk drivers

• Single-site bottle-necks in API isolation or sulfate salt formation
• Release testing capacity tied to validated methods
• Stability lot dependence for expiry dating

When do larotrectinib sulfate exclusivities expire and how does that affect supply?

Featured answer: Exclusivity affects commercial entry timelines, not routine supply availability. Even before generic entry, supply constraints can emerge if there are limited qualified API sources or if process changes require supplements.

Generic entry and supply dynamics

When exclusivity expires and generics enter, price pressure increases and creates buyer leverage. But generic supply depends on whether:

• generic manufacturers secure reliable API sources,
• DMF or synthetic route comparability avoids impurity control failures, and
• drug product manufacturing can meet content uniformity and dissolution specs.

What generic or biosimilar entry risks exist that could destabilize larotrectinib sulfate sourcing?

Featured answer: As a small-molecule targeted oncology drug, larotrectinib sulfate faces generic competition risk rather than biosimilar risk.

Generic entry risks that hit supply

• API process transfer delays or impurities drifting out of spec
• Scale-up failures in the validated intermediate-to-API steps
• Failure of oral solution stability requirements, if the generic targets multiple dosage forms

How should procurement contract terms be structured for larotrectinib sulfate supply continuity?

Featured answer: Contracts should allocate risk across API, intermediates, and drug-product manufacturing, with explicit obligations tied to regulatory compliance and quality agreement performance.

Commercial terms that reduce operational failure risk

• Quality agreement scope covering CoA, impurity profile, residual solvents, and stability protocols
• Forecast commitment language linked to supplier capacity reservations
• Audit rights and right-to-know for deviation and batch failure reporting
• Regulatory change-control notification timelines for site transfers or process deviations
• Temperature/logistics responsibility and serialization/packaging obligations for drug product

Key Takeaways

• Larotrectinib sulfate supply is typically concentrated among qualified API manufacturers and solid-dose/oral fill-finish CMOs, with supplier switching constrained by CMC comparability and validated impurity profiles.
• Procurement due diligence should separate API sourcing risk from drug-product manufacturing risk, then validate that each supplier site is qualified for the specific dosage form and NDC/marketed configuration.
• The biggest continuity risks are usually intermediate availability, impurity-spec control during process transfer, and solid oral/solution manufacturing release testing capacity.
• As generic competition approaches, supply stability depends on whether multiple API routes can meet impurity and residual solvent standards at commercial scale.

FAQs

1. How do I identify larotrectinib sulfate API manufacturers for a specific dosage form (capsule vs oral solution)?
2. What FDA database fields help track manufacturing site qualification for larotrectinib sulfate?
3. What quality attributes matter most for larotrectinib sulfate API release (impurities, residual solvents, salt form)?
4. What CMO capabilities are required for oral solution fill-finish for oncology small molecules?
5. How does generic entry timing change procurement leverage and lead times for larotrectinib sulfate supply?

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. Drug Registration and Listing System. FDA. https://www.accessdata.fda.gov/scripts/cder/drl/
3. U.S. Food and Drug Administration. Drugs@FDA. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
4. European Medicines Agency. Product information for larotrectinib-containing medicines (manufacturers and manufacturing sites). EMA. https://www.ema.europa.eu/