Last updated: May 27, 2026
TACLONEX suppliers (calcipotriene + betamethasone dipropionate) list: manufacturers, contract suppliers, and distribution network
TACLONEX (calcipotriene 0.005% / betamethasone dipropionate 0.064%) is a fixed-dose topical psoriasis therapy marketed in the US by LEO Pharma Inc. as the NDA holder. The commercial supply chain is built around LEO Pharma manufacturing and/or LEO-authorized contract manufacturing, with Finished Dosage Form (FDF) supply tracked through FDA product listings and official labeling.
Who makes TACLONEX in the US and which companies supply the product?
US NDA holder / marketer: LEO Pharma Inc. (TACLONEX drug product and labeling entity in the US).
Product concept: calcipotriene (Vitamin D analog) + betamethasone dipropionate (topical corticosteroid).
Dosage forms typically marketed under TACLONEX brand: ointment and scalp solution (depending on strength/presentation and market).
What is the official FDA drug label supplier for TACLONEX (NDA holder vs manufacturer)?
The drug label identifies the manufacturer or labeler for the finished product. For TACLONEX, the party responsible for US labeling and market authorization is LEO Pharma Inc. as the NDA holder/labeler entity.
For supply-chain due diligence, the practical split is:
- NDA holder / labeler: LEO Pharma Inc.
- Drug product manufacturer (site-level): may be LEO Pharma manufacturing facilities and/or contract manufacturers used by LEO Pharma, as reflected in labeling, product manufacturing section, and FDA drug establishment records where available.
How do you identify contract manufacturing suppliers for TACLONEX?
Contract manufacturing suppliers for marketed drug products are typically identified through one or more of the following in regulated pharma documentation:
- FDA product label “Manufactured for” / “Distributed by” sections
- FDA Drug Establishment Registration and Listing (facility-level) tied to the labeled product
- NDC-to-establishment mapping (commonly used internally for procurement and qualification)
For TACLONEX, the controlling point for supplier onboarding is the NDA holder relationship. In practice, procurement and tech transfer are routed through LEO Pharma’s regulatory and manufacturing operations (with contract sites listed as drug product manufacturing establishments when applicable).
Which TACLONEX package and presentation has which supplier?
TACLONEX is sold in multiple presentations; supplier responsibility can vary by NDC even when the brand and active ingredients are the same. A supplier mapping exercise for purchasing or litigation discovery is done at the NDC level, not just by brand.
TACLONEX presentations commonly include:
- TACLONEX ointment
- TACLONEX scalp (solution)
Each presentation corresponds to distinct product listings that can carry different manufacturing establishments.
What are the key regulatory filings that identify who supplies TACLONEX?
TACLONEX is governed by:
- US NDA coverage for the brand
- FDA product listing and Orange Book entry for exclusivity/patent status (if applicable to the specific product listing/NDC)
- Facility registrations for the manufacturing sites that produce the drug product (and, if needed, drug substance)
Because supplier responsibility can differ across sites and NDCs, the supplier list for operations is derived from:
- NDA product labeling and
- FDA establishment registrations tied to the NDC.
What about drug substance suppliers for calcipotriene and betamethasone dipropionate?
Drug substance procurement is usually handled through:
- LEO Pharma’s qualified API suppliers for calcipotriene and betamethasone dipropionate
- Contract or vertically integrated sources depending on scale, cost, and supply continuity
However, a definitive public “supplier roster” for the underlying API suppliers is not typically fully enumerated in public sources for branded topical products. For supply-chain contracting and quality agreements, the controlling data set is the NDA holder’s qualified vendor list and qualification documents, with facility names reflected where publicly disclosed via registrations and label manufacturing sections.
What is the TACLONEX distribution network in the US?
In the US, the distribution channel is structured through:
- LEO Pharma Inc. for brand commercialization and
- wholesale distribution to pharmacies and institutional accounts
For supplier mapping, distribution does not always equal manufacturing. The manufacturer is the drug product production establishment. Distribution can be handled by logistics providers and wholesalers under label “distributed by” or “marketed by” sections.
Key Takeaways
- LEO Pharma Inc. is the US NDA holder/labeler and is the primary contracting counterparty for TACLONEX supply, manufacturing changes, and supplier onboarding.
- Site-level manufacturing suppliers for TACLONEX are identified through label manufacturing language, NDC-specific listings, and FDA establishment registration records tied to the finished product.
- Drug substance suppliers for calcipotriene and betamethasone dipropionate are typically managed via LEO’s qualified supplier network; public identification is incomplete compared with finished drug product manufacturer attribution.
FAQs
- Does TACLONEX have different manufacturers for ointment vs scalp solution?
- How can I match TACLONEX suppliers by NDC for procurement?
- Where do I find FDA drug establishment registration entries for TACLONEX manufacturing sites?
- Are calcipotriene and betamethasone dipropionate API suppliers publicly listed for TACLONEX?
- Who controls supply chain decisions for TACLONEX in the US: LEO Pharma or wholesalers?
References (APA)
- U.S. Food and Drug Administration. (n.d.). Drug labels and prescribing information for TACLONEX (calcipotriene and betamethasone dipropionate). FDA.
- U.S. Food and Drug Administration. (n.d.). FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (TACLONEX entries). FDA.
- U.S. Food and Drug Administration. (n.d.). Drug Establishment Registration and Listing (facility-level registrations). FDA.
