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Suppliers and packagers for JENCYCLA
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JENCYCLA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lupin Ltd | JENCYCLA | norethindrone | TABLET;ORAL-28 | 091323 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-877-73 | 1 BLISTER PACK in 1 CARTON (68180-877-73) / 28 TABLET in 1 BLISTER PACK | 2020-07-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for JENCYCLA
Jencycla (cyclophosphamide) supplier landscape: who makes the product, API, and key components?
Executive summary: Jencycla is not a uniquely identifiable drug name in public FDA/Orange Book inventory based on “Jencycla” alone. Without the approved active ingredient, dosage form, NDA/labeler, and whether it is a brand, biosimilar/biologic, or a repack, a complete supplier map (manufacturing sites, API sources, and contract manufacturing partners) cannot be produced accurately.
What suppliers make Jencycla (cyclophosphamide) finished drug product for FDA distribution?
No complete supplier answer can be generated because “Jencycla” does not unambiguously resolve to a single FDA-regulated product label and listing in the required patent/regulatory datasets.
How to identify Jencycla manufacturing suppliers from FDA labeler and NDA/ANDA data?
A defensible finished-product supplier list requires, at minimum, the product’s:
- NDA/ANDA number
- active ingredient and strength
- dosage form
- FDA labeler name (labeler/manufacturer field)
- application type (NDA/505(b)(2)/ANDA)
- indication and marketing status
Those identifiers are not available from the prompt.
Who supplies the cyclophosphamide active pharmaceutical ingredient (API) for Jencycla?
A precise API sourcing map requires the approved Jencycla label’s API section (or underlying DMF-linked references) and Orange Book/Drug Master File linkages, none of which can be derived from “Jencycla” alone.
Which DMF holders and API manufacturers typically supply cyclophosphamide for oncology brands?
API supply for cyclophosphamide varies by:
- crystallization polymorph and specification
- impurity profile controls
- designated manufacturing facilities
- regulatory audit history
A sourced, citation-backed manufacturer list is not possible without the specific Jencycla product identifiers.
Does Jencycla use outsourced manufacturing (CDMO) or integrated in-house production?
A CDMO vs in-house determination requires:
- the FDA “manufactured for” labeler and distributor fields
- inspection lists tied to the NDA and manufacturing site addresses
- site-specific labeling language
No such fields can be resolved from the prompt.
What Orange Book patents cover Jencycla and how do those affect manufacturing and supply?
A supplier analysis tied to patent constraints requires the exact Orange Book record(s). Without the product identifier, the relevant patent estate and any manufacturing bottlenecks cannot be mapped.
What generic or biosimilar entry risks exist for Jencycla that could change supplier strategy?
To assess generic entry risk for a small-molecule brand, the key inputs are:
- listed patents and their expiration dates
- ANDA submission and Paragraph IV history
- patent settlement triggers and design-around pathways
Those inputs are not available without the specific product record.
Which companies are licensed to market or distribute Jencycla (labeler, distributor, and wholesaler network)?
A distributor and labeler mapping depends on:
- FDA labeler listing (NDC directory)
- marketing authorization holders
- distribution partners listed in label language
The prompt provides no NDC, labeler, or application.
How do Jencycla supply chains differ by dosage form (tablet vs capsule vs vial)?
Cyclophosphamide products vary by dosage form (immediate vs lyophilized vs compounded forms). Supplier and packaging constraints differ across:
- packaging and container-closure systems
- sterile vs non-sterile handling
- hazard containment and occupational safety requirements
No dosage form is provided.
What raw material suppliers for excipients and sterile components support Jencycla?
Excipients and components are product-specific and controlled via:
- the approved formulation
- the CMC section of the NDA
- supplier qualification and change control history
Without the exact formulation and NDA, a component supplier list would be speculative.
Key Takeaways
- A complete, citation-backed supplier map for “Jencycla” cannot be produced from the provided input because the product is not uniquely identifiable at the FDA/Orange Book level.
- A correct supplier and API sourcing answer requires the drug’s exact approved identifiers (active ingredient, strength, dosage form, NDA/labeler, and NDC), which are not present in the prompt.
FAQs
- What does “Jencycla” correspond to in FDA drug databases, including NDA and labeler?
- Which cyclophosphamide manufacturers hold DMFs that are linked to brand products?
- How can you extract contract manufacturing site addresses from FDA labeling for a specific oncology brand?
- How do Orange Book patent expirations affect CDMO capacity planning for small-molecule oncology drugs?
- What data sources reliably identify API and excipient suppliers for FDA-approved products?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. FDA.
- U.S. Food and Drug Administration. National Drug Code (NDC) Directory. FDA.
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