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Suppliers and packagers for MONISTAT 3
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MONISTAT 3
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Medtech Products | MONISTAT 3 | miconazole nitrate | CREAM;VAGINAL | 020827 | NDA | Insight Pharmaceuticals LLC | 63736-015-18 | 3 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-18) / 5 g in 1 TUBE, WITH APPLICATOR | 1998-03-30 |
| Medtech Products | MONISTAT 3 | miconazole nitrate | CREAM;VAGINAL | 020827 | NDA | Insight Pharmaceuticals LLC | 63736-015-25 | 1 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-25) / 25 g in 1 TUBE, WITH APPLICATOR | 1998-03-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for MONISTAT 3 (miconazole nitrate vaginal): contract manufacturing, active ingredient sourcing, and packaging supply map
MONISTAT 3 is a branded intravaginal antifungal. “Suppliers” typically means three supply layers: (1) active pharmaceutical ingredient (API) and excipients, (2) contract manufacturing for the vaginal drug product (cream/kit components), and (3) secondary packaging and fulfillment components. The public “MONISTAT” brand supply chain is split across multiple companies through labeling/packaging ownership and contract manufacturing, and an exact current supplier roster is not consistently disclosed in public records at product level.
Who manufactures MONISTAT 3 vaginal products?
Direct answer: MONISTAT 3 is marketed under the Johnson & Johnson Consumer/Janssen brand structure for OTC women’s health antifungals. Manufacturing and labeling are typically performed by one or more companies listed on the carton (labeler) and in FDA OTC listings, but the specific contract manufacturers change across time and product configuration.
What does “MONISTAT 3” usually refer to
- Active ingredient: miconazole nitrate (commonly “miconazole nitrate vaginal cream” for antifungal treatment)
- Typical regimen: “3” is used in MONISTAT branding to indicate a short course duration, most often 3 days for intravaginal therapy
What supply chain disclosures to use to identify suppliers
For OTC products like MONISTAT 3, supplier identification is usually derived from:
- Product label “Manufactured for / Distributed by” line (company legal name)
- OTC Drug Product listing (FDA structured labeler and manufacturer fields)
- Device/kit component labeling if it is sold as an applicator kit
- Trademark/brand licensing structure (brand owner vs. contract manufacturer)
Which companies supply the miconazole API used in MONISTAT 3?
Direct answer: Miconazole nitrate API is supplied globally by specialty and generic API manufacturers; however, the specific API supplier for the MONISTAT 3 lots sold today is not reliably stated in public-facing documentation.
Where miconazole nitrate API is sourced in the market
Common API supply archetypes include:
- DMF-holding manufacturers (Drug Master File)
- API producers selling to multiple finished-dose packers
- Integrated chemical producers supplying multiple imidazole antifungal products
How to pin down the MONISTAT 3 API supplier
The most reliable public method is lot-specific tracing via:
- FDA OTC listing manufacturer fields (when consistent)
- Supplier statements on DMF referenced in labeling (not always available in OTC context)
- Contract manufacturing change notifications at the labeler/manufacturer level
What contract manufacturers build MONISTAT 3?
Direct answer: Contract manufacturing for OTC vaginal antifungals is usually done by sterile-topical/semisolid fill-finish capable plants, but the exact plant and company name for MONISTAT 3 depends on the current labeler and configuration (single tube vs. multi-component kit with applicators).
Key manufacturing steps relevant to suppliers
- Semisolid formulation compounding (miconazole nitrate into a vaginal cream base)
- Tube filling or unit packaging assembly
- Sterility is not typically required for topical creams, but microbial controls and preservation strategy are relevant
- Applicator manufacturing and kit packing (if included)
How do MONISTAT 3 packaging suppliers work?
Direct answer: Secondary packaging suppliers typically include:
- Carton and insert printing houses
- Tube laminates or tube manufacturing partners
- Applicator manufacturing partners (if the kit includes applicators)
- Packaging line equipment providers that are not tied to branding but impact specs and QC
What packaging components to map for “suppliers”
- Tube body and cap components
- Applicator (if included) molded polymer parts
- Label stock and overwrap film
- Carton and leaflet printers
Which excipient suppliers support MONISTAT 3 cream formulations?
Direct answer: Excipients for miconazole nitrate vaginal creams are usually sourced from established excipient suppliers (polymeric bases, emulsifiers, preservatives, stabilizers). Exact excipient vendor identity for MONISTAT 3 is not typically disclosed publicly at finished-product level.
Typical excipient categories in vaginal creams
- Emulsifying/wetting base ingredients
- Viscosity and spreadability modifiers
- Preservatives and stabilizers
- Solubilizers/co-solvents where applicable
What sourcing and regulatory constraints affect MONISTAT 3 suppliers?
Direct answer: Suppliers must meet OTC drug quality controls and labeling compliance. Key constraints include:
- Finished product cGMP manufacture and QC release
- Raw material qualification for API and excipients
- Stability data supporting shelf life and storage conditions
- Finished product microbiological controls and preservative efficacy where required
FDA OTC drug compliance touchpoints that drive supplier selection
- OTC monograph compliance (product is commonly marketed under an OTC antifungal monograph framework)
- Drug listing/labeling accuracy for active ingredient strength, dosage form, and regimen claims
- cGMP documentation for compounding and filling
How to identify current MONISTAT 3 supplier names from public records?
Direct answer: Use the labeler/manufacturer line on the specific marketed pack and cross-check with FDA OTC drug listing fields. This yields:
- Labeler company name
- Manufacturer company name(s)
- Dosage form classification and strength mapping
What to extract for supplier mapping
- “Manufactured for” and “Distributed by” entities on carton and tube label
- Lot/batch number trace patterns across different packaging runs
- Any “Repackaged by” lines when product is regionalized
Key Takeaways
- MONISTAT 3 supplier identification requires mapping three layers: API, contract manufacturing, and packaging/kit components.
- Public sources for OTC brands typically provide labeler/manufacturer entities rather than naming the exact API vendor.
- The most reliable supplier roster is derived from the specific pack labeling and corresponding FDA OTC listing manufacturer fields.
FAQs
- How can I find the contract manufacturer for the specific MONISTAT 3 package I have? Look at the carton and tube “Manufactured for” / “Distributed by” lines and cross-check in FDA OTC drug listing manufacturer fields for the same dosage form and strength.
- Do MONISTAT 3 kits use the same applicator supplier across all regions? Not necessarily. Applicators can change via kit assembly vendors; label-level “packed/assembled” lines are the best public signal.
- Is miconazole nitrate API always sourced from the same supplier for MONISTAT 3? Finished products commonly use multiple qualified API sources, so lot-to-lot supplier continuity is not guaranteed in public disclosures.
- What cGMP capabilities are required to manufacture a vaginal miconazole cream? Semisolid compounding, controlled filling/packaging, validated mixing and QC release testing, and stability support for the chosen container-closure system.
- Which FDA records help confirm manufacturers of MONISTAT 3? The FDA OTC drug product listing and the labeler/manufacturer fields corresponding to the product’s labeled strength and dosage form are the primary public starting points.
References
- U.S. Food and Drug Administration. OTC Drug Products (FDA listing data). https://www.accessdata.fda.gov/scripts/cder/ob/search.cfm
- U.S. Food and Drug Administration. Drug Master Files (general information). https://www.fda.gov/drugs/drug-master-files-dmf/about-drug-master-files
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