Last updated: June 5, 2026
REMERON SOLTAB (mirtazapine) suppliers: API, contract manufacturers, and packaging partners
REMERON SOLTAB is the brand name for mirtazapine orally disintegrating tablet (ODT). The supplier universe is typically split across (1) mirtazapine API and intermediates, (2) finished-dose ODT manufacturing, and (3) packaging and labeling under the branded marketing authorization. No complete, authoritative supplier list can be produced from the information provided.
Who manufactures REMERON SOLTAB mirtazapine orally disintegrating tablets (ODT)?
A defensible “supplier” answer for REMERON SOLTAB requires tying the product to its FDA NDA/labeler, the Orange Book “Applicant/Holder”, and the listed drug manufacturing sites (labeler, manufacturing/packaging establishments, and NDA manufacturing changes). Without those identifiers and corresponding regulatory listings, any named supplier set would be unreliable.
Which entity is the NDA/labeler for REMERON SOLTAB?
- The NDA/labeler drives which parties are contracted for:
- tablet core compression and/or ODT lyophilization-like processes (ODT technology varies by product),
- film coating (if any),
- blistering or bottle filling,
- imprinting, bundling, and labeling.
Which manufacturing steps typically involve different suppliers for ODTs?
- API supply chain (mirtazapine synthesis)
- wet granulation vs direct compression route (depends on product)
- ODT structure formation (spray-drying or direct compression with fast-disintegrating excipients)
- packaging (blister vs bottles)
- secondary packaging and distribution chain
What suppliers provide the mirtazapine API for REMERON SOLTAB?
Mirtazapine API sourcing is usually handled through:
- API manufacturers supplying to the NDA holder or its contract development and manufacturing organization (CDMO)
- intermediate suppliers upstream of API (key impurities and polymorph control can constrain interchangeable sourcing)
A correct supplier mapping requires API manufacturer identification through:
- DMF cross-reference and listed manufacturing sites,
- FDA inspections and establishment listings linked to the product,
- confirmed vendor lists in filings and product-specific change notifications.
No such product-specific linkage is available in the input.
Which contract manufacturing organizations make REMERON SOLTAB tablets for the brand?
Finished-dose ODT manufacturing is commonly performed by CDMOs under quality agreements covering:
- incoming material testing and traceability,
- line clearance and batch record controls,
- in-process controls for disintegration and uniformity,
- stability programs for ODT water activity and friability.
Naming the CDMO for REMERON SOLTAB requires establishing the NDA holder and the manufacturing site(s) used for commercial batches. Those data points are not present in the prompt.
How does FDA Orange Book labeling identify REMERON SOLTAB suppliers?
For branded products, FDA Orange Book entries typically identify:
- NDA holder/applicant,
- patent protection data,
- sometimes the dosage form strength and NDA codes, which then connect to labeler/manufacturer information in FDA label and listing records.
What Orange Book data is needed to list suppliers
- exact NDA number for REMERON SOLTAB ODT
- labeler name
- dosage form and strength mapping
- corresponding manufacturing site details from FDA listing databases
Without the NDA/labeler identifiers, a supplier list cannot be produced.
What are the packaging and labeling partners for REMERON SOLTAB?
ODT products are commonly packaged using:
- alu-alu blisters for moisture protection, or
- high-barrier bottles with desiccants.
Packaging and labeling partners can be separate entities from tablet manufacturing. Correct identification requires:
- mapping the product’s manufacturing and packaging establishments to FDA listing records
- confirming site roles (manufacture, pack, label)
Those establishment identifiers are not provided.
Which suppliers are used across REMERON SOLTAB strengths and dosage variants?
Supplier rosters can shift across:
- different strengths (same platform, different batch sizes, different packaging SKUs)
- lifecycle phases (site changes, line changes, post-approval manufacturing transfers)
A strength-by-strength supplier table requires the product’s complete FDA labeling lineup and the manufacturing site history, which is not included.
Which countries and regions supply components for REMERON SOLTAB?
Without the product’s labeled manufacturing site(s) and DMF/API chain details, geography cannot be stated credibly. ODT supply chains frequently span:
- API production in major synthesis hubs,
- formulation and fill-finish in regulated manufacturing regions,
- packaging near commercialization markets.
No country-specific supplier list can be generated from the prompt.
Key Takeaways
- REMERON SOLTAB is an mirtazapine ODT branded product, but a supplier list requires product-specific regulatory identifiers (NDA/labeler and manufacturing establishment records).
- The input does not provide the Orange Book/NDA identifiers or establishment mapping needed to produce an accurate list of API, CDMO, and packaging partners.
FAQs
- What NDA holder is listed for REMERON SOLTAB in the FDA database?
- How can I identify the manufacturing site for an FDA-listed REMERON SOLTAB batch?
- Do REMERON SOLTAB suppliers change by strength or packaging format (blister vs bottle)?
- Are mirtazapine API suppliers interchangeable for REMERON SOLTAB under GMP?
- Where do I find REMERON SOLTAB’s labeler and “manufactured for” information?
References
No sources were provided in the prompt, and no FDA/Orange Book/NDA identifiers were included to support citations.
