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Suppliers and packagers for generic pharmaceutical drug: GIVINOSTAT HYDROCHLORIDE
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GIVINOSTAT 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 |
|---|---|---|---|---|---|---|---|---|---|
| Italfarmaco Spa | DUVYZAT | givinostat hydrochloride | SUSPENSION;ORAL | 217865 | NDA | Italfarmaco SPA | 11797-110-02 | 1 BOTTLE in 1 CARTON (11797-110-02) / 140 mL in 1 BOTTLE (11797-110-01) | 2024-03-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: GIVINOSTAT HYDROCHLORIDE
Who Supplies Givinostat Hydrochloride for Pharmaceutical Use?
Givinostat hydrochloride is supplied through specialty chemical manufacturers and regional distributors that carry the active pharmaceutical ingredient (API) or API-intermediate form used for pharmaceutical R&D and, in some cases, clinical and commercial manufacture. Supplier coverage depends on whether buyers need (1) analytical-reference material, (2) cGMP/API-grade, or (3) intermediates for route development.
What supplier categories provide givinostat hydrochloride?
1) API and bulk-material manufacturers
- Supply the API as givinostat hydrochloride or as the free base with downstream salt formation.
2) Specialty chemical and reference-standard distributors - Supply small- to mid-scale quantities for assay development, stability, and method validation.
3) Contract manufacturing and custom synthesis providers - Supply via custom synthesis, including hydrochloride salt formation, for non-standard volumes or early-stage programs.
Which supplier names typically appear in the givinostat hydrochloride sourcing channel?
The givinostat hydrochloride supply chain most commonly shows up via the following supplier groups in pharma procurement databases and commercial catalogs:
Category A: China-based chemical manufacturers (bulk/API and custom synthesis)
Commonly listed suppliers in this category for small-molecule APIs and salts include:
- Selleckchem (catalog chemicals; also acts as a distributor in many markets)
- MedChemExpress (reference and research-grade supply channel)
- TargetMol (research-grade supply channel)
- ChemScene (research-grade supply channel)
- Aladdin (chemical and pharmaceutical intermediates; catalog salts/derivatives in some cases)
These firms often list “givinostat hydrochloride” or “givinostat” with a hydrochloride form option in their product catalogs (source: vendor catalogs and listings).
Category B: Specialty distributors for pharma-grade/analytical use
The following distributor archetypes frequently carry APIs/salts for analytical and R&D use:
- Thermo Fisher Scientific / Fisher Scientific channel (where applicable through reference and internal catalog partnerships)
- Vendors that specialize in reference standards and method validation materials (often using external manufacturer supply)
These suppliers usually sell the material for QC testing, method development, or feasibility studies, with documentation such as CoA and typical analytical profiles.
Category C: Contract synthesis and salt-formation capability
For givinostat hydrochloride, custom-synthesis providers with salt-formation capability typically offer:
- API synthesis (or key intermediate synthesis)
- conversion to hydrochloride salt (acid/base pairing step)
- scale-up under pilot or production frameworks (where contracted)
These suppliers usually appear under “custom synthesis,” “API production,” or “salt formation” capabilities rather than as fixed catalog SKUs.
How to validate a givinostat hydrochloride supplier for a pharma program
Supplier qualification for an active pharmaceutical ingredient salt typically hinges on documentation, not just catalog availability. The most decision-critical checkpoints:
Documentation package
- CoA with identification (HPLC/UPLC assay and impurity profile where offered)
- Analytical certificate and typical impurity disclosure
- Solubility and stability statements where the salt form is critical for formulation
Quality system posture
- cGMP or GMP-like production capability if intended for clinical/commercial use
- Batch traceability and controlled manufacturing records
Regulatory alignment
- Ability to support DMF/ASMF pathways where required by jurisdiction and project stage
Procurement reality: givinostat hydrochloride is commonly sourced as a salt form
Many supply arrangements list either:
- givinostat hydrochloride directly, or
- givinostat free base plus hydrochloride conversion step performed by the supplier.
The buyer-side implication is that the salt form is sometimes a supplier-controlled conversion rather than an independently isolated material.
Key Takeaways
- Givinostat hydrochloride is sourced through three channels: API/bulk manufacturers, specialty research-grade distributors, and contract synthesis providers with salt-formation capability.
- Catalog availability does not equate to cGMP/API suitability; the decisive factor is the supplier’s documentation and manufacturing framework.
- Common sourcing names appear in research-chemical catalogs (Selleckchem, MedChemExpress, TargetMol, ChemScene, Aladdin), while pharma-grade supply typically runs through contract manufacturing and quality-auditable API producers.
- For pharma programs, confirm hydrochloride specification via CoA and salt-form identity testing and align vendor quality posture with clinical or commercial needs.
FAQs
1) Is givinostat hydrochloride sold as an API or primarily for research use?
It is sold in both contexts, but many public listings emphasize research-grade supply; pharma-grade supply depends on whether the supplier runs an audited/controlled API manufacturing framework.
2) Why do suppliers sometimes list givinostat and givinostat hydrochloride separately?
Different listings often reflect either a direct salt SKU or conversion capability (free base to hydrochloride) and can affect documentation and impurity profiles.
3) What documents matter most when buying the hydrochloride salt form?
The CoA and identification/assay data tied to the salt form matter most, along with impurity reporting and traceability consistent with the buyer’s intended use.
4) Can contract manufacturers make givinostat hydrochloride from givinostat free base?
Yes. Salt formation (hydrochloride) is a standard process step for small-molecule APIs where the supplier has appropriate synthesis and quality controls.
5) How do I compare suppliers for cost and speed?
Compare lead time and price only after normalizing for grade (research vs cGMP/API), batch size, documentation completeness, and whether hydrochloride identity is verified in the CoA.
References
[1] Selleckchem. Givinostat hydrochloride product listing.
[2] MedChemExpress. Givinostat hydrochloride product listing.
[3] TargetMol. Givinostat hydrochloride product listing.
[4] ChemScene. Givinostat hydrochloride product listing.
[5] Aladdin. Givinostat hydrochloride / givinostat derivative catalog listing.
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