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Suppliers and packagers for generic pharmaceutical drug: levamlodipine maleate
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levamlodipine maleate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cspc Ouyi | CONJUPRI | levamlodipine maleate | TABLET;ORAL | 212895 | NDA | CSPC Ouyi Pharmaceutical Co. Ltd | 24075-0411-3 | 2.5 mg in 1 BOTTLE (24075-0411-3) | 2021-10-08 |
| Cspc Ouyi | CONJUPRI | levamlodipine maleate | TABLET;ORAL | 212895 | NDA | CSPC Ouyi Pharmaceutical Co. Ltd | 24075-0411-5 | 2.5 mg in 1 BOTTLE (24075-0411-5) | 2021-10-08 |
| Cspc Ouyi | CONJUPRI | levamlodipine maleate | TABLET;ORAL | 212895 | NDA | CSPC Ouyi Pharmaceutical Co. Ltd | 24075-0411-9 | 2.5 mg in 1 BOTTLE (24075-0411-9) | 2021-10-08 |
| Cspc Ouyi | CONJUPRI | levamlodipine maleate | TABLET;ORAL | 212895 | NDA | CSPC Ouyi Pharmaceutical Co. Ltd | 24075-0413-3 | 5 mg in 1 BOTTLE (24075-0413-3) | 2021-10-08 |
| Cspc Ouyi | CONJUPRI | levamlodipine maleate | TABLET;ORAL | 212895 | NDA | CSPC Ouyi Pharmaceutical Co. Ltd | 24075-0413-5 | 5 mg in 1 BOTTLE (24075-0413-5) | 2021-10-08 |
| Cspc Ouyi | CONJUPRI | levamlodipine maleate | TABLET;ORAL | 212895 | NDA | CSPC Ouyi Pharmaceutical Co. Ltd | 24075-0413-9 | 5 mg in 1 BOTTLE (24075-0413-9) | 2021-10-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
LEVAMLODIPINE MALEATE Suppliers and Contract Manufacturing: Who Makes It, How to Source API and Tablets, and What IP/Regulatory Constraints Matter
Levamolopine maleate supply is constrained by (1) API-manufacturing capacity for levamlodipine besylate/“maleate” salt forms, (2) salt-form control (specs and polymorph/hydrate behavior), and (3) tablet formulation control (salt loading, dissolution specs, and stability). The practical sourcing decision splits into API suppliers (levamlodipine salt or intermediate) and finished-dose manufacturers (tablets/capsules) with validated commercial processes.
Who are the suppliers of levamlodipine maleate API?
Answer: API sourcing typically comes from bulk-API producers in China and India, plus a smaller set of specialty/regulated-market suppliers that can support DMF filing and batch traceability.
Because “levamlodipine maleate” is a salt name often used in product dossiers and purchase orders, supplier selection hinges on whether the vendor supplies:
- Levamlodipine base with salt-form conversion capability
- Levamlodipine maleate directly (preferred for consistency)
- A registered DMF, CEP, or equivalent dossier package
- Controlled particle size distribution and defined polymorph/hydrate
What to verify in an API supplier for levamlodipine maleate
Key commercial and quality checkpoints that determine whether the supplier can be used for launch-quality manufacture:
| Supplier qualification item | Why it matters for levamlodipine maleate |
|---|---|
| Salt confirmation (maleate form) | Prevents batch-to-batch drift in dissolution and exposure |
| Polymorph/hydrate control | Impacts bioavailability and stability shelf life |
| Impurity profile | Regulator scrutiny is high for leachables from conversion steps |
| Residual solvents | Directly affects specification release and regulatory compliance |
| DMF/CEP readiness | Determines how fast you can file and how quickly generics can proceed |
| Stability program data (ICH zones) | Determines hold times and commercial shelf life claims |
| Analytical method capability | Ensures comparable dissolution and impurity testing to reference |
Which companies supply levamlodipine maleate tablets and finished dosage forms?
Answer: Finished-dose supply is usually handled by Indian and Chinese contract manufacturers with tablet lines capable of controlling dissolution targets for the maleate salt.
Finished-dose availability depends on whether the request is for:
- Private-label tablets for local markets
- Contract manufacturing for EU/US-oriented customers
- Technology transfer under CDMO terms
Tablet manufacturing constraints for levamlodipine maleate
| Manufacturing parameter | What to lock down |
|---|---|
| Salt content assay | Prevents potency drift after blending |
| Dissolution specification | Salt form and particle size drive dissolution performance |
| Granulation method | Wet granulation vs direct compression changes content uniformity |
| Storage stability | Maleate salt can be sensitive to humidity; container closure matters |
| Packaging | Desiccant and blister/HDPE selection tied to stability results |
Are API suppliers and salt-form converters the same for levamlodipine maleate?
Answer: Not usually. Many “levamlodipine maleate” listings are fulfilled by conversion from levamlodipine base or other salt forms through controlled crystallization.
In practice, supply routes break into two models:
- Direct salt supplier model: vendor supplies levamlodipine maleate with established specs and stability.
- Conversion model: vendor supplies levamlodipine base, then customers or the vendor converts to maleate under an agreed crystallization and QC protocol.
From a sourcing standpoint, the conversion model can widen timelines if polymorph and impurity control are not already validated for maleate in your intended dosage strength.
What manufacturing locations dominate levamlodipine maleate supply?
Answer: The concentration of API and CDMO capacity is highest in India and China for small-molecule antihypertensives and salt-form variants.
Within these regions, supplier strength typically correlates with:
- Prior commercial production of amlodipine-family salts
- Experience with dissolution-driven tablet specs
- Ability to support regulatory dossier components (DMF, CoA, validation packages)
How do you qualify a levamlodipine maleate supplier for regulated markets?
Answer: Qualify on documentation depth and batch consistency, not on price listings.
A qualification pack that tends to determine approval speed:
| Document / record | Supplier capability indicator |
|---|---|
| CoA with full release specs | Analytical robustness |
| Batch manufacturing records summary | Process traceability |
| Stability protocol and results | Shelf-life feasibility |
| Method validation summary | Ensures your QC alignment |
| Traceability for starting materials | Impurity control and audit readiness |
| Audit trail readiness | Ability to pass GMP inspection expectations |
What risks exist if a levamlodipine maleate supplier uses a different salt form or polymorph?
Answer: Dissolution and exposure can shift, raising both regulatory and commercial risks.
Typical failure modes in sourcing:
- Supplier supplies an alternate salt but uses the same product name in documentation
- Polymorph/hydrate differences shift dissolution curves
- Impurity profile changes when conversion steps are modified
- Humidity sensitivity affects content and potency during stability storage
What do buyers usually buy: levamlodipine maleate API, intermediate, or finished tablets?
Answer: Buyers typically contract either API or tablets; intermediate procurement is used when the buyer can run salt formation and tablet production internally.
Decision logic:
- If you are filing dossiers: API with consistent maleate specs and impurity profile is the starting point.
- If you are commercializing tablets: a CDMO that already owns a dissolution-qualified formulation is often faster.
- If you are building an internal platform: intermediate + salt formation in-house can reduce dependence but increases process development workload.
How does FDA or EMA status affect levamlodipine maleate supplier selection?
Answer: Supplier documentation (DMF/CEPs, GMP compliance history) is a gating factor for regulated-market entries.
For US filings, what matters is the ability to support:
- Adequate API documentation tied to the DMF
- Evidence that the commercial manufacturing site meets expectations for inspections
- Consistency of dissolution and impurity profile with your formulation program
For EU/UK, what matters is similar dossier readiness and GMP inspection performance.
What IP considerations affect levamlodipine maleate sourcing and generic entry?
Answer: IP risk usually sits in formulation, process, and controlled-release/dosage-form variants, plus method-of-use claims. Salt-form variants are sometimes less protected, but not always.
For sourcing decisions:
- If you are making tablets, protectable elements can include crystallization method, particle engineering, and dissolution targets.
- If you are filing ANDA/MAA, check whether the reference product’s claims cover your specific strength, salt, and process route.
Supplier diligence checklist for levamlodipine maleate (actionable)
Answer: Use a qualification checklist tied to stability, salt confirmation, and batch-to-batch comparability.
- Salt identity confirmation: maleate must be verified by appropriate solid-state analytics.
- Impurity comparability: confirm limits align with your dossier and internal specs.
- Dissolution performance: require data tied to the intended tablet formulation strength.
- Stability evidence: humidity and temperature stress results mapped to your packaging plan.
- GMP site readiness: verify that the manufacturing site has active inspection readiness for your target market.
Commercial sourcing structure: who supplies what in levamlodipine maleate programs?
Answer: Supply chains are usually segmented: API producers, salt-form converters or multi-product intermediates, and tablet CDMOs with tablet dissolution know-how.
| Buyer objective | Typical supplier type | What you request |
|---|---|---|
| Bulk API procurement | API manufacturer | maleate specs, DMF/CoA, stability data |
| Faster market launch | Tablet CDMO | dissolution-qualified formulation, validation packs |
| Internal formulation control | Salt/Intermediate supplier | base + salt formation protocol and QC support |
| Multi-market compliance | Regulated-market API supplier | dossier-ready documentation, audit support |
Key Takeaways
- Levamlodipine maleate supply success depends on whether you can lock the salt form, solid-state form, and dissolution-linked tablet specs across commercial batches.
- Sourcing typically separates into API suppliers and tablet CDMOs, with salt-form conversion sometimes layered in between.
- Regulated-market entry is dominated by documentation depth (DMF/CEP readiness) and GMP site audit readiness, not by the supplier’s marketing claims.
- The highest procurement risk is mislabeled or incompletely controlled salt/polymorph variation that can shift dissolution and exposure.
FAQs
-
How can I confirm levamlodipine maleate salt identity before signing a supply agreement?
Require solid-state verification and release-spec linkage to your intended dissolution and stability performance. -
What does dissolution testing reveal about levamlodipine maleate supplier quality?
Differences in particle size and solid-state form often show up as dissolution curve drift, even when assay/potency looks similar. -
Does changing a levamlodipine maleate API supplier require formulation bridging?
Often yes. Batch comparability and dissolution alignment can require bridging work, especially if solid-state or impurity profiles shift. -
Can levamlodipine maleate be converted from levamlodipine base without regulatory impact?
Conversion can be viable, but you need controlled crystallization, impurity control, and validated specs to avoid regulatory friction. -
What packaging choices matter most for levamlodipine maleate tablets stability?
Moisture barrier performance and container closure strategy are critical if maleate form stability is humidity sensitive.
References
No sources cited because supplier company lists require exact identification of named vendors and verification from current catalogs/DMFs/Orange Book-style listings, which is not provided here.
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