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Suppliers and packagers for MIDODRINE HYDROCHLORIDE
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MIDODRINE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Alembic | MIDODRINE HYDROCHLORIDE | midodrine hydrochloride | TABLET;ORAL | 214734 | ANDA | Alembic Pharmaceuticals Limited | 46708-338-31 | 100 TABLET in 1 BOTTLE (46708-338-31) | 2021-01-22 |
| Alembic | MIDODRINE HYDROCHLORIDE | midodrine hydrochloride | TABLET;ORAL | 214734 | ANDA | Alembic Pharmaceuticals Limited | 46708-338-71 | 500 TABLET in 1 BOTTLE (46708-338-71) | 2021-01-22 |
| Alembic | MIDODRINE HYDROCHLORIDE | midodrine hydrochloride | TABLET;ORAL | 214734 | ANDA | Alembic Pharmaceuticals Limited | 46708-339-31 | 100 TABLET in 1 BOTTLE (46708-339-31) | 2021-01-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Midodrine Hydrochloride Suppliers: Market Supply Map and Procurement-Grade Targets
Midodrine hydrochloride is a widely used generic active pharmaceutical ingredient (API) in the US and Europe for orthostatic hypotension. Supply is dominated by established API manufacturers with multi-site batch production, plus distributors that source from multiple API plants and manage regulatory documentation (e.g., CoA, CoC, DMF references where applicable).
Who manufactures midodrine hydrochloride API at scale?
Tier 1: API manufacturers (direct supply channels commonly available)
Below are established producers that have been active in midodrine hydrochloride API supply and filings (direct manufacture or contracted manufacture by the group).
| Supplier / Group | Supply posture | Typical procurement path | What buyers usually get |
|---|---|---|---|
| Chiral Technologies India Pvt. Ltd. | API and intermediates manufacturer | DMF/letter support through sales and regulatory | Batch-specific documentation, DMF-linked dossiers where available |
| Cipla (API ecosystem) | API sourcing and/or manufacturing footprint within complex portfolio | Through procurement channels tied to generic medicines and APIs | Traceable documentation and controlled specs |
| Mylan N.V. / Viatris (legacy generic API ecosystem) | Supplier ecosystem for midodrine-containing products; API sourcing through group networks | Procurement via corporate/vendor qualification routes | CoA/CoC, compliance packages for generics manufacturing |
| Teva (API ecosystem) | Vertical and contract supply presence in generics | Direct or through qualified distributors | Regulatory-ready COA formats, stability package availability |
| Siegfried (API/CDMO ecosystem, depending on site scope) | Contract manufacturing ecosystem | CDMO procurement route | GMP batches, change-control visibility tied to site quality |
Procurement note: In practice, buyers often qualify multiple plants within a group structure, because regulatory documentation and batch availability depend on the specific site that runs the campaign.
Who distributes midodrine hydrochloride API into pharma supply chains?
Distributors typically do not manufacture API; they aggregate stock and documentation from API plants. Their value is speed of fulfillment and document control, especially for smaller MOQs or short notice.
| Supplier / Distributor | Supply posture | Best-fit use case | Procurement signal to request |
|---|---|---|---|
| Brenntag | Specialty chemicals and pharma ingredients distributor | Rapid replenishment, multi-source options | ASMF/DMF reference mapping and CoA format consistency |
| TCI Chemicals / specialty pharma trade channels | Chemical supply through trade networks | Early-stage procurement and pilot lots (where qualified) | GMP status for API, not only chemical grade |
| Rhodium / regional pharma distributors (varies by region) | Regional aggregation | Local availability and logistics | Proof of GMP API supply, traceability chain |
Procurement rule: Require the distributor to identify the actual API manufacturing site on every supply release. Many distributors can ship the same labeled item from different sources.
What quality and documentation should be locked before purchase?
Midodrine hydrochloride buyers should set procurement requirements around API grade, dossier linkage, and batch-level compliance.
Minimum document pack for API purchase
- Certificate of Analysis (CoA) for each batch (test methods, limits, results, and reference to specification)
- Certificate of Conformance (CoC) or vendor statement covering compliance status
- GMP statement identifying the manufacturing site
- Drug Master File (DMF) / ASMF reference if your regulatory strategy uses it
- Method of analysis (full or referenced) if your QA requires verification
- Stability documentation if you plan to rely on it for retest/shelf-life justification
Quality checkpoints that frequently block supply
- Salt form identity and polymorph/solid-state control
- Impurity profile alignment with the purchaser’s target spec
- Residual solvents and residual catalysts (if applicable)
- Water content and assay within tighter in-house tolerances
How to structure supplier qualification for midodrine hydrochloride?
A qualification program should separate regulatory documentation readiness from manufacturing reliability.
Step-by-step supplier qualification set
- Regulatory mapping
- Confirm DMF/ASMF presence or that the supplier provides a complete regulatory pack for your intended jurisdiction.
- Spec alignment
- Confirm assay range, specific impurities, water/solvent limits, and particle/solid-state parameters if required.
- GMP and change control
- Require notification and impact assessment for site changes, manufacturing route changes, and specification updates.
- Supply continuity
- Demand lead-time ranges, batch size capability, and multi-month production scheduling.
- Analytical method support
- Align on whether you will test with your own methods versus supplier method reliance.
What are the main supplier-selection drivers?
Midodrine hydrochloride procurement typically turns on these variables:
- Dossier compatibility (DMF/ASMF linkage and file holder)
- Batch-to-batch consistency (impurity control and assay stability)
- Solid-state control (salt identity confirmation and moisture/particle attributes)
- Lead time and campaign scheduling (availability for repeat runs)
- Audit outcomes (GMP audit readiness and data integrity practices)
Which supplier types match which procurement scenarios?
| Scenario | Best supplier type | Why it fits |
|---|---|---|
| First commercial batch under tight timelines | Distributor that can name the plant and ship with CoA/CoC | Faster availability if plant is already qualified in your chain |
| Multi-year supply contract | Direct API manufacturer | Contract stability, lower unit cost, and tighter change control |
| Niche grade or special spec window | Direct manufacturer or specialized API supplier | Better control of impurities and solid-state attributes |
| Limited QA bandwidth at early phase | Distributor (with plant transparency) | Documentation package reduces method verification effort |
What to request in the RFQ to get procurement-grade answers?
To avoid non-usable offers, buyers should require response fields that map directly to manufacturing and compliance.
- Manufacturing site name and batch release location
- GMP certificate for the site
- DMF/ASMF status and whether it is open for reference
- Proposed specification sheet (with limits)
- Typical CoA format including impurities, residual solvents, water content
- Lead time and minimum order quantity (MOQ)
- Change control policy and notification windows
Key Takeaways
- Midodrine hydrochloride API supply is available through both direct API manufacturers and distributors, with the distributor route requiring strict plant transparency for compliance.
- Supplier selection should prioritize DMF/ASMF linkage, spec alignment, and batch consistency over price alone.
- RFQs must force disclosure of the actual manufacturing site, the spec sheet, and the document pack (CoA/CoC/GMP statement) to ensure regulatory usability.
FAQs
1) Can a distributor supply midodrine hydrochloride API compliant for GMP manufacturing?
Yes, if the distributor provides the actual manufacturing site, supplies GMP documentation, and includes a batch-specific CoA tied to the supplier’s specification.
2) How do buyers reduce the risk of failing impurity specifications?
Qualify at least two supply sources, require impurity profile alignment in the spec, and obtain multiple consecutive CoAs during vendor onboarding.
3) What is the most important documentation item for midodrine hydrochloride procurement?
The DMF/ASMF linkage status (if your regulatory pathway relies on it) and the batch-specific CoA with full impurity and solvent panels.
4) What lead-time variables most affect midodrine hydrochloride supply continuity?
Manufacturing campaign scheduling, batch size constraints at the running site, and change-control events that trigger requalification.
5) Should buyers qualify both a manufacturer and a distributor?
Yes. Manufacturers support long-term contract reliability; distributors help with shortfalls but should be qualified using plant-level transparency.
References
[1] FDA. “Drugs@FDA: Drug Product Database.” US Food and Drug Administration, accessed 2026-04-23.
[2] EMA. “European Medicines Agency: Medicines database.” European Medicines Agency, accessed 2026-04-23.
[3] Chiral Technologies India Pvt. Ltd. Company and product information for pharmaceutical intermediates and API supply, accessed 2026-04-23.
[4] Brenntag. Pharmaceutical ingredients and specialty chemicals supply information, accessed 2026-04-23.
[5] Teva. Corporate information on API and generics manufacturing ecosystem, accessed 2026-04-23.
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