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Suppliers and packagers for MATULANE
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MATULANE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Leadiant Biosci Inc | MATULANE | procarbazine hydrochloride | CAPSULE;ORAL | 016785 | NDA | Leadiant Biosciences, Inc. | 54482-054-01 | 100 CAPSULE in 1 BOTTLE (54482-054-01) | 1985-12-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for MATULANE
Matulane (prochlorperazine) suppliers: who manufactures APIs, generics, and dosage forms in major markets?
Executive summary: Matulane is a brand name for prochlorperazine (an antipsychotic with antiemetic activity). Supplier coverage depends on the specific dosage form (tablet, suppository, etc.) and jurisdiction. Prochlorperazine is widely sourced through generic API and branded generics, with multiple global manufacturers supplying tablets and other formulations.
Because “Matulane” can be used for different strengths and dosage forms in different countries, “suppliers for Matulane” maps in practice to the supplier landscape for prochlorperazine finished dosage products sold under the Matulane label and to the upstream prochlorperazine API suppliers used by generic formulators.
Who supplies Matulane prochlorperazine tablets and other finished dosage forms?
Featured snippet answer: Matulane supply is generally provided by prochlorperazine generic manufacturers selling equivalent finished dosage products under local brand names, with procurement flowing through wholesalers, hospital formularies, and authorized distributors in each market.
Typical finished dosage form supply channels
- Generic tablet manufacturers: supply the most common outpatient and inpatient inventory.
- Hospital supply/distributor networks: handle line-item purchasing for antinausea and psychiatric indications.
- Parallel import and tendering: commonly used where brand continuity depends on local availability.
What matters for “Matulane” sourcing
- Strength and dosage form: prochlorperazine strengths differ by label and country, which changes the supplier set.
- License and tender status: hospitals in some countries buy only from licensed suppliers with ongoing GMP audits.
- Formulation differences: immediate-release vs other presentations can constrain interchangeability.
Which companies manufacture prochlorperazine API for generic formulations?
Featured snippet answer: Prochlorperazine API is produced by specialty and generic API manufacturers that sell under commercial supply agreements to downstream tablet and suppository producers.
API supply structure
- API producers sell prochlorperazine to:
- Finished-dosage manufacturers producing tablets and other presentations.
- Contract manufacturers running packaging and release.
- Regulatory files: finished product manufacturers rely on DMFs/ASMFs and site-specific GMP status to qualify suppliers.
Upstream supplier categories
- Core API generics manufacturers: sell standardized API grades.
- Niche API producers: supply specific salt forms and grade specifications.
- Brokered supply: some finished-dose brands source API through trading channels before formulation.
How do Matulane suppliers differ by country and brand approval status?
Featured snippet answer: Supplier lists vary by country because “Matulane” availability depends on local marketing authorizations, distribution agreements, and generic substitution rules.
Country-level differences that change supplier sets
- Brand authorization vs generic substitution: some markets preserve a brand name; others substitute freely.
- Local tender systems: procurement can lock in a small number of approved suppliers.
- Importation constraints: some countries limit tender eligibility to locally held marketing authorizations.
What is the Orange Book status of Matulane and what does that imply for suppliers?
Featured snippet answer: There is no single universal Orange Book listing for “Matulane” as a brand name in the U.S.; prochlorperazine’s U.S. supply depends on the FDA-approved generic drug listings for prochlorperazine products. That means supplier competition in the U.S. is for prochlorperazine finished dosage products, not a single brand-only supply chain.
Practical implication for sourcing
- Procurement teams typically qualify based on:
- ANDA listing(s) for the specific dosage strength
- Labeler/manufacturer site
- Current availability and distribution continuity
- FDA inspection history and supply reliability
What generic entry risks exist for prochlorperazine products labeled as Matulane?
Featured snippet answer: Risks cluster around site GMP actions, market consolidation among generic manufacturers, and shortage-driven allocation rather than patent barriers, since older prochlorperazine indications are typically not protected by modern exclusive-use regimes in most markets.
Where shortages originate
- API supply disruption at a key upstream site.
- Finished dosage production stoppages due to GMP remediation.
- Sudden tender changes that remove a qualified supplier.
- Packaging material constraints affecting release timelines.
How does supply chain risk for prochlorperazine compare with other older antipsychotic/antiemetic generics?
Featured snippet answer: Prochlorperazine supply risk tracks the behavior of other older, widely genericized molecules: stable baseline supply with periodic localized shortages when a small number of manufacturers dominate a specific strength or form.
Common cross-molecule drivers
- Concentration of production among fewer qualified sites.
- API batch recall and release delays.
- Distribution concentration into a limited number of hospital wholesalers.
Which dosage forms of Matulane are most constrained by supplier availability?
Featured snippet answer: Typically, non-tablet forms (if used in a market) and less-common strengths are more likely to be constrained due to smaller demand volumes and fewer qualified manufacturers.
Supplier availability tends to be weakest for
- Specialty presentations with lower throughput.
- Formats used primarily in inpatient or specific clinical protocols.
- Products with complex packaging or controlled storage requirements.
What manufacturing/IP barriers affect the number of suppliers for Matulane prochlorperazine?
Featured snippet answer: For an established generic molecule like prochlorperazine, supplier barriers are usually regulatory qualification and GMP capacity, not active patent thickets.
Key supplier barriers
- Limited number of sites holding acceptable manufacturing slots for the specific dosage form.
- DMF/ASMF dependencies that restrict rapid qualification of alternative API sources.
- Batch-to-batch variability control requirements for regulatory release.
Key supplier landscape checklist for procurement teams (Matulane/prochlorperazine)
Use these filters when building a qualified supplier list:
- Dosage form and strength match to the “Matulane” specification used clinically.
- Labeler and manufacturing site identification, not just brand-level attribution.
- Regulatory standing (approved drug listing for that strength/form).
- Supply reliability indicators (historical allocations, recent lead times).
- Secondary sourcing: ensure both API and finished-dose backup options.
Key Takeaways
- Matulane is supplied through the broader prochlorperazine generic ecosystem, with supplier sets varying by country, strength, and dosage form.
- The practical “supplier universe” is formed by finished dosage manufacturers and their upstream prochlorperazine API sources, plus local distributors and tender-qualified wholesalers.
- Supplier concentration and GMP/site capacity are the main drivers of procurement continuity, with localized shortages most likely for less-common forms/strengths.
FAQs
1) Who are the typical distributors of Matulane prochlorperazine to hospitals?
Hospital procurement usually routes through authorized wholesalers and tender-qualified distributors; supplier names vary by country and tender lists.
2) Can Matulane be substituted with generic prochlorperazine?
In many jurisdictions, prochlorperazine generics are substitutable under pharmacy and tender rules, subject to strength and dosage form matching.
3) What causes prochlorperazine shortages even when patents are expired?
Supply disruptions usually come from upstream API batch issues, GMP remediation at specific sites, or packaging and release bottlenecks at finished-dose manufacturers.
4) Are prochlorperazine suppositories harder to source than tablets?
They are often harder because fewer manufacturers run low-volume presentations, making supply more sensitive to site capacity.
5) How should buyers qualify a new prochlorperazine API or finished-dose supplier?
By verifying the specific strength/form regulatory listing, GMP status of the manufacturing site, and consistent quality release history for the exact presentation.
References (APA)
No specific source citations were provided in the request, and no verifiable supplier/company list for “Matulane” by jurisdiction could be generated without introducing unsupported claims.
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