Last Updated: June 25, 2026

Suppliers and packagers for bijuva


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bijuva

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132 NDA Mayne Pharma LLC 50261-211-05 1 BLISTER PACK in 1 CARTON (50261-211-05) / 5 CAPSULE in 1 BLISTER PACK 2019-04-03
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132 NDA Mayne Pharma LLC 50261-251-05 1 BLISTER PACK in 1 CARTON (50261-251-05) / 5 CAPSULE in 1 BLISTER PACK 2023-03-31
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132 NDA Mayne Pharma LLC 50261-251-30 1 BLISTER PACK in 1 CARTON (50261-251-30) / 30 CAPSULE in 1 BLISTER PACK 2023-03-31
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for bijuva

Last updated: May 24, 2026

BIJUVA Suppliers (API, Contract Manufacturing, and Packaging)

BIJUVA (estradiol/progesterone) relies on a vertically integrated supply chain for drug product and is sourced through established branded-drug procurement channels. The publicly discoverable supplier list is not complete from a single view because BIJUVA’s finished goods sourcing, API manufacturing, and repackaging/packaging vendors are distributed across Orange Book listings, FDA facility databases, and commercial contract manufacturing relationships.

No information was provided that identifies the specific BIJUVA suppliers (API manufacturers, contract manufacturers, fill-finish sites, or packaging vendors) with enough precision to produce an accurate supplier roster.

Which companies supply BIJUVA drug product to the U.S. market?

No complete, citable supplier roster is available in the provided inputs.

Does BIJUVA use contract manufacturing for the capsule and packaging?

No complete, citable supplier roster is available in the provided inputs.

Where are BIJUVA manufacturing sites located (fill-finish, packaging, labeling)?

No complete, citable supplier roster is available in the provided inputs.

What API suppliers make estradiol and progesterone for BIJUVA?

No complete, citable API supplier roster is available in the provided inputs.

Are estradiol and progesterone sourced from multiple API manufacturers?

No complete, citable API supplier roster is available in the provided inputs.

What chemical intermediates or controlled substance handling is involved?

No complete, citable supplier roster is available in the provided inputs.

How do BIJUVA’s suppliers differ by strength and dosage form?

No complete, citable supplier roster is available in the provided inputs.

Is BIJUVA supplied through multiple warehouses, distributors, or wholesalers?

No complete, citable supplier roster is available in the provided inputs.

What does the FDA facility list show for BIJUVA manufacturing sites?

No facility-level dataset was provided.

What does the Orange Book list for BIJUVA manufacturer and applicant information?

No Orange Book identifiers (applicant/labeler, NDA number) were provided in the inputs.

Which contract manufacturers are active in BIJUVA commercialization?

No complete, citable supplier roster is available in the provided inputs.

What licensing or manufacturing agreements affect BIJUVA supply continuity?

No agreement-level information was provided that ties specific suppliers to BIJUVA.

What generic or biosimilar pressures could disrupt BIJUVA supplier capacity?

No competitive or litigation/supply chain linkage was provided.

Key Takeaways

  • A precise BIJUVA supplier list (API manufacturers, contract manufacturers, packaging and labeling vendors, and distribution wholesalers) cannot be produced from the information provided.
  • Supplier identification for BIJUVA requires Orange Book applicant/labeler data, FDA facility inspections/registration for the NDA, and company-specific manufacturing/packaging confirmations.

FAQs

  1. Who is the NDA holder/labeler for BIJUVA in the FDA system?
  2. Which FDA-registered sites manufacture the BIJUVA capsule dosage form?
  3. Who manufactures the estradiol component used in BIJUVA?
  4. Who fills and packages BIJUVA at commercial scale?
  5. Are there multiple BIJUVA manufacturing sites for supply redundancy?

References

No sources were provided or cited.

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