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Suppliers and packagers for generic pharmaceutical drug: molindone hydrochloride
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molindone 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 |
|---|---|---|---|---|---|---|---|---|---|
| Epic Pharma Llc | MOLINDONE HYDROCHLORIDE | molindone hydrochloride | TABLET;ORAL | 090453 | ANDA | EPIC PHARMA, LLC | 42806-336-01 | 100 TABLET in 1 BOTTLE (42806-336-01) | 2018-10-17 |
| Epic Pharma Llc | MOLINDONE HYDROCHLORIDE | molindone hydrochloride | TABLET;ORAL | 090453 | ANDA | EPIC PHARMA, LLC | 42806-337-01 | 100 TABLET in 1 BOTTLE (42806-337-01) | 2018-10-17 |
| Epic Pharma Llc | MOLINDONE HYDROCHLORIDE | molindone hydrochloride | TABLET;ORAL | 090453 | ANDA | EPIC PHARMA, LLC | 42806-338-01 | 100 TABLET in 1 BOTTLE (42806-338-01) | 2018-10-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
MOLINDONE HYDROCHLORIDE: Supplier Map for APIs and Key Raw Materials
Who supplies molindone hydrochloride as an API?
Molindone hydrochloride is marketed as an antipsychotic API under multiple manufacturer and distributor listings. The suppliers below are the entities that have commercial catalog or label claims for the substance in market-facing documentation.
Common supplier/distributor channels (market-facing)
| Supplier type | Entity | What they supply | Evidence |
|---|---|---|---|
| API/distributor | Cayman Chemical | Molindone hydrochloride (catalog item) | Product listing for molindone hydrochloride (Cayman Chemical) |
| API/distributor | Sigma-Aldrich (MilliporeSigma) | Molindone hydrochloride (catalog item) | Product listing for molindone hydrochloride (MilliporeSigma) |
| API/distributor | Tokyo Chemical Industry (TCI) | Molindone hydrochloride (catalog item) | Product listing for molindone hydrochloride (TCI) |
| API/distributor | MedKoo Biosciences | Molindone hydrochloride (catalog item) | Product listing for molindone hydrochloride (MedKoo) |
| API/distributor | Chem-Impex | Molindone hydrochloride (catalog item) | Product listing for molindone hydrochloride (Chem-Impex) |
Source types: these suppliers publish market catalog entries; they are not, by themselves, proof of commercial API supply for GMP drug substance. They are, however, reliable starting points for sourcing paths and cross-checking for GMP availability via distributor statements and COA/quality packages on request.
Which companies list molindone hydrochloride in chemical catalog systems?
The following companies publicly list “molindone hydrochloride” as a purchasable chemical item:
- Cayman Chemical (catalog listing)
- MilliporeSigma (Sigma-Aldrich) (catalog listing)
- TCI (catalog listing)
- MedKoo Biosciences (catalog listing)
- Chem-Impex (catalog listing)
Each uses standard catalog-grade product pages and typically provides item identifiers plus downloadable documentation (COA/SDS), which can be used to validate identity and grade for procurement screening.
Who supplies the underlying synthesis inputs most commonly used for molindone hydrochloride?
Molindone hydrochloride procurement frequently depends on access to intermediate-building-block suppliers (rather than only the final API salt). Common input classes for procurement due diligence include:
- Molindone free base (base compound)
- Salt conversion suppliers, or API suppliers that provide hydrochloride salt directly.
- Hydrochloric acid (HCl) for salt formation
- Industrial chemical supply chain (commodity HCl) is typically used unless the supplier supplies the salt-forming package under controlled conditions.
- Solvents and reagents used in crystallization and salt formation
- Procurement typically uses standard salt-formation solvents and purification reagents under GMP/ICH Q7 controls when used for drug substance.
For each input class, the supplier decision is controlled by whether the purchasing spec requires:
- GMP drug substance (ICH Q7, traceability, CoA with identity/purity)
- Research-grade chemical (catalog-grade documentation)
The market catalog suppliers above often provide either R&D-grade supply or non-GMP support; GMP drug substance supply should be validated through COA, GMP status, and quality agreements.
How to use this supplier map for procurement screening
A practical screening path that reduces spend and lead time risk:
Step 1: Start with salt-name matches and request COA/SDS
Use the entities that list “molindone hydrochloride” for fastest item-level validation:
- Cayman Chemical
- MilliporeSigma
- TCI
- MedKoo Biosciences
- Chem-Impex
Step 2: Validate whether the listing is API-grade vs research-grade
Confirm:
- identity method (typically IR and/or NMR, plus chromatographic purity)
- assay range and impurity profile
- residual solvents and water content
- supply format (powder grade, particle size, polymorph claims if any)
Step 3: Confirm GMP readiness for drug substance use
For drug substance sourcing, request:
- GMP manufacturing site statement
- batch manufacturing record summary or quality agreement
- control strategy references (ICH Q7 compliance, change control)
Key procurement deliverables to require from any supplier
For molindone hydrochloride, procurement due diligence typically hinges on these documents and specs:
- SDS and COA for each batch
- HPLC assay and impurities (including specific named impurities if your internal spec requires them)
- Residual solvents (GC)
- Water content (KF/LOD)
- Particle size (if you require compressibility or dissolution consistency)
- Salt form confirmation (chloride presence and salt definition)
- Stability data or at least a shelf-life statement under defined storage
Risk and availability signals in supplier selection
- Catalog suppliers can often provide rapid supply for screening lots.
- GMP API suppliers may have longer lead times and higher documentation overhead.
- Salt form supply can vary by crystallization process; suppliers should provide evidence of consistent physical properties if you have a dosage form that is sensitive to polymorph or solvate.
Key Takeaways
- Multiple market catalog suppliers list molindone hydrochloride under their chemical product lines: Cayman Chemical, MilliporeSigma, TCI, MedKoo Biosciences, and Chem-Impex.
- These listings are strong for fast screening and identity confirmation, but GMP drug substance status must be validated through COA content and GMP/site documentation.
- For salt-form procurement, confirm chloride/salt identity and impurity profile, and require residual solvent and water controls aligned to your internal specifications.
FAQs
1) Are the catalog suppliers also GMP API manufacturers?
Not necessarily. Many catalog suppliers sell research-grade materials. GMP status depends on the manufacturing site and the batch documentation they can provide for drug-substance use.
2) What documents should be required with the first commercial lot of molindone hydrochloride?
At minimum: SDS and COA with identity plus assay/purity testing, plus residual solvents and water content if you are using it for drug substance.
3) Can molindone hydrochloride be sourced via molindone free base plus hydrochloric acid?
Yes in principle, but your feasibility depends on whether you need a validated drug substance salt form and whether you can control crystallization and impurity introduction under your quality system.
4) Why do suppliers’ impurity profiles matter for molindone hydrochloride?
Impurity control impacts batch release, stability, and downstream formulation performance. Salt formation and purification steps often shift impurity outcomes.
5) Which supplier list is best for initial procurement screening?
Use supplier catalog pages to shortlist sources quickly, then validate through COA, test methods, and GMP readiness before placing higher-volume orders.
References (APA)
[1] Cayman Chemical. (n.d.). Molindone hydrochloride (Product page). https://www.caymanchem.com/
[2] MilliporeSigma (Sigma-Aldrich). (n.d.). Molindone hydrochloride (Product page). https://www.sigmaaldrich.com/
[3] Tokyo Chemical Industry (TCI). (n.d.). Molindone hydrochloride (Product page). https://www.tcichemicals.com/
[4] MedKoo Biosciences. (n.d.). Molindone hydrochloride (Product page). https://www.medkoo.com/
[5] Chem-Impex. (n.d.). Molindone hydrochloride (Product page). https://www.chem-impex.com/
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