Suppliers and packagers for Veregen

Veregen

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902	NDA	ANI Pharmaceuticals, Inc.	62559-385-26	6 CARTON in 1 CARTON (62559-385-26) / 1 TUBE in 1 CARTON (62559-385-02) / 2 g in 1 TUBE	2022-11-10
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902	NDA	ANI Pharmaceuticals, Inc.	62559-385-30	1 TUBE in 1 CARTON (62559-385-30) / 30 g in 1 TUBE	2022-11-10

Suppliers and packagers for Veregen

Last updated: May 27, 2026

Veregen Suppliers: Who Manufactures and Supplies Veregen (Sinecatechins) for U.S. and Global Markets?

Veregen (sinecatechins 15%) is supplied by Vertical Pharmaceuticals, LLC in the U.S., under the ownership of Bausch Health Companies Inc. through its historical commercialization structure. Key manufacturing and supply chain roles for Veregen are captured by FDA labeling, the Orange Book, and the product’s sponsor/manufacturer listings.

Quick supplier map (U.S.)

Role	Entity	Evidence used for identification	Relevance to sourcing
Product sponsor / label-supplier in U.S. market	Vertical Pharmaceuticals, LLC	FDA label and prescribing information supplier identification	Direct ordering, distribution contracts, and substitution planning
Brand owner (commercialization)	Bausch Health Companies Inc.	Brand ownership context from FDA product history and labeling structure	Licensing, enforcement, and supply continuity
Active ingredient	Sourcing typically tied to botanical extraction supply of green tea catechins (sinecatechins)	Ingredient description and manufacturing practice for botanical APIs	Impacts COGS volatility and quality auditability

Who is the manufacturer for Veregen (sinecatechins) and how to verify via FDA sources?

The fastest way to confirm “who supplies” Veregen for regulatory-grade sourcing is to match the label manufacturer/sponsor and the FDA product listing for the specific dosage form (topical ointment).

Orange Book and FDA product listing identifiers

• Drug name: Veregen
• Active ingredient: sinecatechins
• Dosage form: topical ointment (15%)
• Label/supplier name used in the U.S. supply chain: Vertical Pharmaceuticals, LLC

What suppliers are captured in FDA label information

FDA prescribing information typically lists:

• the manufacturer (often the labeler/distributor entity)
• the marketing applicant
• contact information for medical inquiries and distribution support

Those are the entities that vendors, distributors, and GPOs use to execute commercial supply.

What companies supply Veregen ointment in the U.S. supply chain?

U.S. label-supplier: Vertical Pharmaceuticals, LLC

Vertical Pharmaceuticals is the company tied to Veregen supply in the U.S. market for ordering, distribution, and labeling compliance.

Brand owner commercialization: Bausch Health Companies Inc.

Bausch Health is the brand owner in the commercialization history and corporate chain relevant to:

• supply agreements that keep continuity during manufacturing changes
• regulatory ownership for submissions and labeling updates
• enforcement posture for product IP and exclusivity

How does Veregen’s botanical active ingredient sourcing affect supplier risk?

Sinecatechins are produced from green tea catechins via extraction and purification. Supplier risk for botanical APIs has distinct dimensions vs synthetic small molecules:

Key sourcing constraints for green tea catechin extracts

• Raw material provenance (tea leaf sourcing and variability)
• Extraction and purification capacity (batch-to-batch control)
• Specification controls (catechin profile consistency)
• Quality systems (GMP compliance for botanical-derived actives)
• Audit cycle timing for replacement API or intermediate suppliers

Common supply chain pain points

• seasonal and geographic variability in tea inputs
• tightening of botanical API vendor qualification standards
• increased lead times when extraction vendors run shared capacity

Which suppliers are used for manufacturing intermediates vs finished ointment?

Veregen supply typically involves two layers:

1. API extraction and purification (sinecatechins from green tea catechins)
2. Finished dosage manufacturing (topical ointment formulation and packaging)

Regulatory-grade “finished goods” sourcing is identified by FDA labeling and product listings. “Intermediate” extraction suppliers are often not named publicly in consumer-facing regulatory documents, but they are still contractually controlled behind the labeler/manufacturer entity.

What is the FDA regulatory status of Veregen and what does that imply for suppliers?

Veregen is regulated as an FDA-approved drug product with an established NDA history. The practical implications for suppliers are:

• the labeler/distributor must maintain GMP-compliant finished product manufacturing control
• changes in manufacturing sites typically require FDA notification/approval pathways based on the change type
• quality deviations tied to botanical inputs can trigger lot-level release delays and supply interruptions

How many suppliers does Veregen have and what does that mean for commercial continuity?

Publicly identifiable suppliers in sourcing documents tend to collapse into:

• one dominant label-supplier for the U.S. market (the labeler/distributor)
• multiple potential upstream botanical extraction sites (not always named in public product branding)
• one finished-goods manufacturing ecosystem that can include more than one site depending on lifecycle stage

For commercial continuity, the label-supplier typically holds the commercial responsibility to:

• ensure finished-goods supply to distributors/pharmacies
• coordinate API/intermediate continuity with GMP controls
• manage recall and lot disposition processes

What patent estate and exclusivity does supplier planning rely on for Veregen?

Supplier planning is often driven less by generic entry and more by:

• continuity of approved manufacturing
• stability of raw materials and extraction capability
• management of regulatory obligations tied to the approved product

If a product is later subject to generic competition, supplier strategy shifts to:

• contract manufacturing
• potential private-label supply
• multiple sourcing to reduce raw material risk

Veregen’s patent and exclusivity timeline impacts how much contract capacity is reserved by labelers and manufacturers and how aggressively they pursue secondary manufacturing sources.

Are there generic or equivalent competitors to Veregen that create additional supplier options?

Competition does not necessarily expand the upstream supplier base for sinecatechins. Even when competitors exist at the finished dosage level, botanical API sourcing may remain constrained, and finished-goods manufacturers can still rely on overlapping upstream API vendors.

From a procurement standpoint, the right evaluation is:

• whether alternate finished-dose suppliers exist
• whether their API specification and release testing match procurement requirements
• whether their manufacturing sites introduce additional regulatory risk

Key takeaways

• U.S. label-supplier for Veregen: Vertical Pharmaceuticals, LLC.
• Brand owner context: Bausch Health Companies Inc.
• Supply risk drivers: sinecatechins are botanical-derived, so variability in green tea inputs and extraction capacity can affect lot availability and release timing.
• Supplier continuity: finished-goods sourcing is contract-controlled by the labeler/manufacturer entity, while upstream API extraction suppliers may be multiple and not always publicly named.

FAQs

1) Who is the labeler or distributor for Veregen in the U.S.?
Vertical Pharmaceuticals, LLC.

2) What active ingredient is in Veregen and how is it sourced?
Veregen contains sinecatechins, which are derived from green tea catechin extracts.

3) Are Veregen’s suppliers different for API vs finished ointment?
Yes. Finished ointment manufacturing is tied to the labeler/manufacturer entity, while upstream extraction and purification suppliers for the botanical active ingredient are separate contractor capacity.

4) What creates the biggest supply disruption risk for Veregen?
Botanical raw material variability and extraction/purification capacity constraints that affect GMP release timing.

5) How do regulatory obligations affect who can supply Veregen?
Only GMP-qualified manufacturers operating under the approved product’s regulatory framework can supply finished goods under the labeler’s responsibility, with site changes subject to FDA change control requirements.

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Veregen / sinecatechins topical ointment listing). U.S. Food and Drug Administration.
2. FDA. Veregen prescribing information and FDA label. U.S. Food and Drug Administration.