Last Updated: July 10, 2026

Suppliers and packagers for generic pharmaceutical drug: crinecerfont


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crinecerfont

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Neurocrine CRENESSITY crinecerfont CAPSULE;ORAL 218808 NDA Neurocrine Biosciences, Inc. 70370-5025-1 60 CAPSULE in 1 BOTTLE (70370-5025-1) 2024-12-13
Neurocrine CRENESSITY crinecerfont CAPSULE;ORAL 218808 NDA Neurocrine Biosciences, Inc. 70370-5050-1 60 CAPSULE in 1 BOTTLE (70370-5050-1) 2024-12-13
Neurocrine CRENESSITY crinecerfont CAPSULE;ORAL 218808 NDA Neurocrine Biosciences, Inc. 70370-5100-1 30 CAPSULE in 1 BOTTLE (70370-5100-1) 2024-12-13
Neurocrine CRENESSITY crinecerfont SOLUTION;ORAL 218820 NDA Neurocrine Biosciences, Inc. 70370-5250-1 30 mL in 1 BOTTLE (70370-5250-1) 2024-12-13
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for generic pharmaceutical drug: crinecerfont

Last updated: June 6, 2026

CRINECERFONT Suppliers: Who Manufactures and Supplies the Pharmaceutical Ingredient, Drug Product, and Contract Manufacturing?

CRINECERFONT supplier coverage depends on what “CRINECERFONT” refers to in the source supply chain (active pharmaceutical ingredient versus finished dosage form) and which market (US FDA-licensed product versus ex-US). Without that mapping, a complete, accurate supplier list cannot be produced.

What suppliers make CRINECERFONT active pharmaceutical ingredient (API)?

No authoritative supplier set can be compiled from the term “CRINECERFONT” alone.

Which entities typically appear as CRINECERFONT API suppliers?

  • Primary API manufacturers (or API license holders)
  • Contract manufacturing organizations (CMOs) for API synthesis
  • API packagers and re-packers
  • Traders/distributors supplying wholesalers

Who supplies CRINECERFONT finished drug product (tablets, capsules, injections)?

No authoritative finished-product supplier set can be compiled from the term “CRINECERFONT” alone.

What finished dosage forms might be supplied?

  • Oral solid dose (tablets, capsules)
  • Oral liquids
  • Sterile injectables (if applicable, typically with specialized sterile CMOs)
  • Ophthalmic, inhalation, transdermal (if applicable)

Which contract manufacturing organizations (CMOs) supply CRINECERFONT?

A CMO list requires identifying the exact marketed product name, strength, dosage form, and the regulated manufacturing sites (labeler, application holder, or FDA listing), which the input does not establish.

What manufacturing/IP terms typically drive “supplier” identification?

  • Labeler (application holder)
  • Site(s) for drug substance and drug product
  • Marketing authorization holder versus manufacturing authorization holder
  • Labeling claims tied to specific manufacturing sites

What is the FDA Orange Book status of CRINECERFONT and who are the listed sponsors?

No Orange Book mapping can be produced because the product cannot be reliably linked to an Orange Book listing from “CRINECERFONT” alone.

What you normally extract from Orange Book entries

  • Proprietor and patent holder(s)
  • Drug product name, dosage form, route
  • Approval date
  • Listed patents (composition, formulation, method of use)
  • Exclusivity periods

What generic or biosimilar supply risk exists for CRINECERFONT?

Supplier lists for generics and biosimilars require confirming whether CRINECERFONT is an approved reference listed drug and whether any ANDA/BLA filings exist. No filing association can be produced from “CRINECERFONT” alone.

ANDA and Paragraph IV supplier dynamics

  • Starter generic manufacturers seeking access to supply
  • Settlement agreements affecting launch timing
  • Approval bottlenecks at manufacturing site level

How does CRINECERFONT supplier coverage differ by country or region?

A global supplier list requires country-specific authorization and labeling. “CRINECERFONT” alone does not identify which national medicines register(s) correspond to the product.

Where regional supplier lists are usually sourced

  • EMA member states (where applicable)
  • UK MHRA listings
  • Canada NDS/Drug Submission information
  • India CDSCO and national import authorization records
  • Local tender databases (public procurement)

Key Takeaways

  • A complete, accurate “suppliers for CRINECERFONT” list cannot be produced from the single term “CRINECERFONT” without a verifiable mapping to an API name or approved finished drug product record.
  • Supplier identification for high-stakes decisions requires binding the name to a specific labeler/application holder and manufacturing site record (for API and drug product), which is not inferable from the provided input.

FAQs

  1. How can I identify CRINECERFONT API suppliers reliably?
  2. Where do I find the drug product manufacturer for CRINECERFONT (labeler and manufacturing sites)?
  3. Does CRINECERFONT have any ANDA or Paragraph IV challenges impacting supply?
  4. What databases list international suppliers for a specific CRINECERFONT strength and dosage form?
  5. How do contract manufacturing sites affect CRINECERFONT supplier qualification and compliance?

References

(No sources were cited because no authoritative supplier mapping for “CRINECERFONT” can be established from the provided information.)

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