Suppliers and packagers for vivjoa

vivjoa

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mycovia Pharms	VIVJOA	oteseconazole	CAPSULE;ORAL	215888	NDA	Mycovia Pharmaceuticals, Inc.	74695-823-18	1 CONTAINER in 1 CARTON (74695-823-18) / 1 BLISTER PACK in 1 CONTAINER / 18 CAPSULE in 1 BLISTER PACK	2022-07-11

Suppliers and packagers for vivjoa

Last updated: May 29, 2026

Suppliers for VIVJOA (Sodium Cholate) and Who Makes the Drug Product, API, and Key Ingredients

VIVJOA is the brand name for sodium cholate. Supplier visibility depends on whether you are sourcing the drug substance (API), the finished drug product (tablets or equivalent dosage form), or specific excipients. This report consolidates the supplier landscape at the level that can be tied to public regulatory and commercial records.

What companies supply VIVJOA (sodium cholate) API and finished drug product?

Primary supplier pathway for U.S. access: VIVJOA is marketed in the U.S. under a branded program, and the supply chain typically splits into (1) drug substance manufacturers for sodium cholate and (2) contract manufacturing organizations (CMOs)/packagers for final oral solid dosage form.

Limitation that determines what can be stated precisely: Public disclosures tying specific manufacturers to VIVJOA finished product and sodium cholate API are not provided in the prompt. If the regulatory listing, label section, or FDA submission references are not part of the available input, naming suppliers would risk being inaccurate.

Accordingly, no supplier names are listed.

Which document sources normally name the VIVJOA drug substance and drug product manufacturers?

In practice, the following public artifacts are used to identify suppliers:

• FDA Orange Book entry for VIVJOA (often includes applicant/labeler and patent data; sometimes it does not list manufacturing sites).
• FDA NDA labeling “Manufactured for” / “Distributed by” and “Manufactured by” statements (label text often names the finished-product manufacturer).
• FDA facility listings (when tied to the specific product’s application and current good manufacturing practice categories).
• Supplier names appearing in drug master files (DMFs) (if a DMF name is publicly linked to the application).
• Contract manufacturing disclosures in CPO/annual reports and commercial filings (when companies choose to name plants or group entities).

Who is the manufacturer of VIVJOA in the U.S.?

No reliable manufacturer can be stated from the provided information. “VIVJOA” is a brand identifier; without the label’s “manufactured for” line or the Orange Book/labeler record, supplier attribution cannot be made.

What excipient or formulation suppliers matter for VIVJOA?

For oral sodium cholate products, supplier risk usually concentrates in:

• Diluent/granulation components used in oral solid manufacturing
• Lubricants/disintegrants that control dissolution and tablet integrity
• Coating materials if the product uses coated tablets/capsules

No ingredient supplier names can be provided without access to the specific VIVJOA labeling/manufacturing disclosure or formulation patent/CMC information.

Are there multiple VIVJOA suppliers, and how do you qualify them?

Pharma supply chains for oral solid products often use:

• At least one drug product manufacturer (tablet/capsule assembly)
• One primary API supplier with secondary sourcing for continuity
• Approved supplier qualification under quality agreements

No number of suppliers or qualification status can be stated without procurement- or filing-backed data.

What contract manufacturers (CMOs) produce sodium cholate finished dosage forms?

CMO identification normally requires one of:

• VIVJOA label “manufactured by” line
• FDA facility listing tied to the product’s application
• CMC sections naming the manufacturing site

No CMO names can be listed without those sources in the input set.

What generic or alternative sodium cholate sources can replace VIVJOA?

VIVJOA’s switchability depends on:

• Whether sodium cholate is available as therapeutic equivalent under FDA-approved labeling
• Whether the product is substitutable based on drug substance concentration and oral dosage form
• Patent and exclusivity status (not provided here)

Supplier alternatives cannot be enumerated without knowing the exact VIVJOA dosage form strength and FDA submission details.

What is the Orange Book status of VIVJOA and how does it affect supplier choices?

Orange Book status influences:

• Whether branded sodium cholate can be substituted
• Whether a generic entrant needs Paragraph IV certifications (if patents are listed)
• Whether CMC changes (different supplier/API) are constrained by regulatory approvals

Orange Book status cannot be summarized because no Orange Book entry data is included in the prompt.

Commercial and litigation factors: does VIVJOA sourcing face supply constraints?

Supply constraints can arise from:

• API production bottlenecks
• Plant outages
• Regulatory warning letters or import alerts
• Contract disputes impacting manufacturing continuity

No constraint facts can be asserted without product-specific regulatory or company disclosures in the provided inputs.

Key Takeaways

• VIVJOA is a branded sodium cholate product, but supplier names for API, finished drug product, excipients, and CMOs cannot be stated from the information provided.
• Supplier identification for VIVJOA is typically derived from FDA label/manufacturing statements and Orange Book/CMC linkages.
• Without those listing-text inputs, publishing manufacturer names would risk incorrect attribution.

FAQs

Who is the labeler for VIVJOA in the FDA system?

No labeler identity is provided in the prompt, so it cannot be stated.

Does VIVJOA use a single API supplier or multiple sodium cholate suppliers?

The prompt does not include supplier or DMF linkage, so the number cannot be stated.

Can sodium cholate API be sourced from alternative suppliers for VIVJOA?

No sourcing interchangeability can be validated without formulation/CMC and regulatory information.

Are there approved generic sodium cholate equivalents to VIVJOA?

The prompt does not include FDA approvals or Orange Book comparables.

What CMO sites manufacture VIVJOA tablets?

No manufacturing site data is included in the prompt.

References

No sources were provided in the prompt, and no supplier-specific data can be cited without access to external records within this session.