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Suppliers and packagers for generic pharmaceutical drug: pexidartinib hydrochloride
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pexidartinib hydrochloride
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Daiichi Sankyo Inc | TURALIO | pexidartinib hydrochloride | CAPSULE;ORAL | 211810 | NDA | Daiichi Sankyo Inc. | 65597-407-20 | 1 BOTTLE in 1 CARTON (65597-407-20) / 120 CAPSULE in 1 BOTTLE | 2023-02-01 |
| Daiichi Sankyo Inc | TURALIO | pexidartinib hydrochloride | CAPSULE;ORAL | 211810 | NDA | Daiichi Sankyo Inc. | 65597-407-28 | 1 BOTTLE in 1 CARTON (65597-407-28) / 28 CAPSULE in 1 BOTTLE | 2023-02-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: pexidartinib hydrochloride
PEXIDARTINIB HYDROCHLORIDE Suppliers: API, Intermediates, and Finished-Dosage Manufacturing Landscape
Pexidartinib hydrochloride supply chain is dominated by a limited group of API manufacturers and a small set of contract development and manufacturing organizations (CDMOs) that can execute kinase inhibitor API scale-up, salt formation, and solid-dose formulation. For commercial supply, the most decision-relevant inputs are (1) confirmed API-sourcing partners for the marketed product, (2) whether the supply chain includes a validated salt-conversion step for the hydrochloride form, and (3) whether API and intermediates are controlled by active process patents or compound-family exclusivities that drive preferred supplier lists.
Who supplies pexidartinib hydrochloride API and intermediates?
The market for pexidartinib hydrochloride API is typically supplied by companies that support both (a) the free base or the API polymorph/form requirement and (b) final conversion to the hydrochloride salt with controlled residuals and particle characteristics. In practical sourcing terms, CDMOs that serve kinase inhibitor programs can provide one or more of the following supply nodes:
- API synthesis (route-dependent, multi-step chemistry to the pexidartinib core)
- Key intermediates and late-stage intermediates (bottleneck compounds in the longest lead steps)
- Salt formation and isolation (hydrochloride salt conversion with specifications for HCl equivalents, water content, and impurity profile)
- Solid dosage formulation manufacturing (tablet or capsule fill-finish depending on product format)
- Packaging and distribution under GMP
What to expect in supplier qualification. Kinase inhibitor APIs are generally qualified through a combination of GMP audits, DMF cross-references (where available), CoA traceability, impurity-participation alignment, and stability/handling data for the specific salt form. Salt formation is a critical stage because impurity and polymorph outcomes can affect downstream formulation and dissolution.
Which chemical suppliers typically provide late-stage intermediates?
Late-stage intermediates for kinase inhibitors are often sourced from specialty intermediate manufacturers or made in-house at API scale. Your sourcing decisions usually hinge on:
- Whether intermediates are supplied as “catalog” items or custom intermediates
- Whether the supplier has a validated hydrogenation/halogenation/coupling sequence relevant to pexidartinib’s synthetic route
- Whether intermediates are supplied under GMP with full impurity panels consistent with API registration filings
What finished-dose manufacturers produce pexidartinib hydrochloride for the US market?
Finished-dose supply generally maps to the holder of the approved NDA and its contract partners for commercial scale. For a drug like pexidartinib hydrochloride, the finished-dose manufacturer must support:
- GMP solid-dose production
- Formulation control linked to bioavailability specifications
- Stability programs for the final dosage form
- Labeling and packaging that match FDA-approved configuration
Practical reality for sourcing. Even when multiple API suppliers exist, finished-dose production is frequently consolidated into one or two qualified sites. This concentrates formulation know-how, stability history, and batch-record controls. For licensing or contingency supply, buyers usually seek visibility into both API and finished-dose manufacturing sites.
How do pexidartinib hydrochloride suppliers handle hydrochloride salt conversion?
Hydrochloride salt formation is typically executed through controlled acid-base conversion using validated HCl sources and process parameters that control:
- Salt yield and isolation efficiency
- Residual chloride and residual solvents
- Water content and hygroscopicity risk
- Impurity carryover from free base to the salt
- Particle size and morphology affecting dissolution and tableting behavior
Which salt-formation capabilities matter most for sourcing?
When selecting a supplier, the differentiators are usually:
- Confirmed control of residual solvents and residual chloride (with routine analytical controls)
- Experience handling salt hygroscopicity in storage and downstream formulation
- Documented impurity formation/transition rules between free base and hydrochloride API
- Ability to provide stability data aligned to the finished-dose shelf-life program
What contract manufacturing organizations can supply pexidartinib hydrochloride under GMP?
For a pexidartinib hydrochloride supply strategy, CDMOs fall into two categories:
- API CDMOs that produce pexidartinib hydrochloride API (including salt conversion)
- Formulation/DP (drug product) CDMOs that take API and manufacture the marketed dosage form under QMS controls
Selection criteria used by high-stakes buyers.
- Scale capability for kinase inhibitor API (kg-to-multi-kg batches depending on demand)
- Analytical package for impurity profiling, residual solvents, and salt-form verification
- Technology transfer maturity (batch records, LIMS method sets, and in-process controls)
- Regulatory track record for ANDA-relevant chemistry systems (even if not directly filing an ANDA)
Which supplier regions are most relevant for pexidartinib hydrochloride availability?
Commercial API supply is often concentrated in regions with deep fine-chemical and GMP API ecosystems. From a procurement and resiliency standpoint, buyers typically evaluate:
- US/EU-qualified supply chains for finished-dose GMP compliance
- India and China for API and intermediate production capacity, with layered compliance controls
- Contract manufacturing footprints that can be switched in contingency planning
What drives regional choice. Lead times, audit outcomes, ability to control impurity panels, and historical performance on salt-form consistency.
What patent barriers can restrict pexidartinib hydrochloride suppliers?
Supplier availability can be constrained by compound, salt, polymorph, intermediate, and process patents that affect whether a CDMO can make an API route commercially. In practice, barriers show up as:
- Process restrictions that limit the route a supplier can legally use
- Scope limits for improvements or alternate intermediates
- Requirements to license technology or operate under a supplier authorization
Impact on sourcing. Even if technical capability exists, legal clearance can limit supplier lists for API and salt conversion steps.
How does supplier switching work for pexidartinib hydrochloride API?
Switching API suppliers for a kinase inhibitor salt form typically triggers a regulatory and technical change workflow, including:
- Comparative testing of API critical quality attributes (CQAs)
- Impurity equivalency and dissolution alignment with the reference API
- Formulation bridging for the new supplier’s API
- Stability commitments on the new API or salt form
Common procurement bottlenecks. Salt-form consistency, impurity matching, and dissolution behavior can be harder to bridge than simple potency equivalence.
What generic and biosimilar risk exists for pexidartinib hydrochloride supply?
Pexidartinib hydrochloride is a small-molecule drug, so the principal competition risk is generic entry rather than biosimilars. Supplier behavior can shift ahead of generic launches in expectation of:
- Reduced demand at the brand price point
- Contract renegotiations that introduce additional API sourcing
- Increased availability of alternative routes that clear legal barriers
Supply-chain planning consequence. Brand holders often expand supplier capacity or lock-in volumes to control supply in anticipation of exclusivity gaps.
Supplier due diligence checklist for pexidartinib hydrochloride
A buyer-focused supplier review usually covers:
- GMP compliance: inspection outcomes, audit recency, data integrity controls
- DMF/Regulatory alignment: cross-references and documentation readiness
- Analytical capability: impurity panel coverage, salt-form identity confirmation, residual solvent controls
- Salt conversion controls: reproducibility of hydrochloride characteristics
- Scale readiness: batching, filtration and isolation capacity, drying performance
- Change control readiness: ability to execute tech transfer and bridging studies
- Supply reliability: lead times, raw material availability (HCl equivalents, solvents, catalysts), and contingency plans
Key Takeaways
- Pexidartinib hydrochloride supply is constrained by API salt-form control and impurity consistency, not just by core synthesis capability.
- Supplier selection hinges on hydrochloride salt conversion robustness and validated impurity panels that align to the approved reference.
- Finished-dose manufacturing is often concentrated in one or few qualified sites even when multiple API sources exist.
- Patent and process constraints can materially narrow the set of legally usable CDMO routes for pexidartinib hydrochloride.
FAQs
1) What documents show which companies supply pexidartinib hydrochloride API?
DMFs, FDA regulatory submissions referencing manufacturing sites, and GMP inspection records are the primary evidence sources.
2) Can a CDMO supply pexidartinib hydrochloride without owning the full API route?
Yes, but the supplier must control salt conversion, impurity fate, and provide a GMP-compliant analytical and manufacturing package for the final API salt.
3) What quality attributes are most sensitive for pexidartinib hydrochloride transitions?
Salt form identity, water content/hygroscopicity, residual impurities, residual solvents, particle size/morphology, and dissolution behavior.
4) How long does supplier qualification typically take for pexidartinib hydrochloride?
Qualification and bridging timelines usually depend on analytical equivalency and stability data requirements, not just on batch release potency.
5) What sourcing risks matter most for hydrochloride kinase inhibitor APIs?
Raw material availability for HCl-based salt formation, impurity formation under alternate routes, and reproducibility of drying/isolation conditions.
References
No cited sources were provided in the prompt.
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