Last updated: June 6, 2026
ELIDEL is the brand for pimecrolimus 1% cream (topical calcineurin inhibitor). The supplier set for ELIDEL is determined primarily by (1) who holds the FDA-approved applications for the strength and dosage form and (2) who is listed as manufacturer on the approved labeling and FDA product records for drug product and, where disclosed, drug substance.
If ELIDEL refers to U.S.-market product supply, the authoritative supplier identifiers are the FDA label “Manufactured for” or “Distributed by” statements, and the FDA registration and listing records tied to the approved drug product.
H1: ELIDEL supplier list (pimecrolimus 1% cream) drug product manufacturer and drug substance suppliers
Who supplies ELIDEL (pimecrolimus 1% cream) in the US market?
Answer: ELIDEL supply originates from the manufacturer(s) named on the FDA-approved U.S. labeling (drug product) and from the contract or in-house makers of pimecrolimus drug substance used in that approved manufacturing route.
What to look for on the ELIDEL label to identify suppliers
- “Manufactured for” line (drug product contract manufacturer or brand owner).
- “Distributed by” line (commercial distributor, not always the same as the manufacturer).
- Strength and dosage form match: pimecrolimus 1% cream.
How FDA data ties to supplier identification
- FDA registration for the finished dosage form ties to the entity operating the manufacturing site.
- FDA product listing ties the marketed product to a manufacturing/labeler chain.
- Orange Book patent listings, while not supplier data, anchor the U.S. product identity and application references.
What contract manufacturers make ELIDEL cream under the approved NDA?
Answer: The contract manufacturing company for ELIDEL is the firm listed on the FDA-approved label as “Manufactured for,” and the manufacturing sites appear through FDA establishment registration and listing associated with the approved finished product.
Which supply roles exist in ELIDEL’s chain
- Finished dosage form manufacturer (cream filling, assembly, packaging).
- Drug substance manufacturer (pimecrolimus synthesis).
- Secondary packaging and label operations (sometimes separate sites).
- Contract logistics and distribution (often the label “Distributed by” entity).
Why supplier lists can differ by lot and lifecycle stage
- NDA lifecycle changes can shift finished dosage form manufacturing sites without changing the brand.
- Labeling can keep the labeler/distributor constant while swapping manufacturing sites via manufacturing supplements.
What is the drug substance sourcing for pimecrolimus (ELIDEL API suppliers)?
Answer: The drug substance (API) supplier is identified in regulatory filings as the company manufacturing pimecrolimus used for the approved finished product, but API vendor names may not appear on the commercial carton or package insert.
Where API supplier names appear in practice
- FDA manufacturing supplement documentation (CMC) for the NDA.
- Quality agreements between the NDA holder and API manufacturer.
- Sometimes only the finished-product manufacturer is visible in public consumer-facing documents.
What is the Orange Book status of ELIDEL and how does it affect supplier competition?
Answer: Orange Book status affects generics and supplier competition more than it changes who can manufacture the brand, because the brand’s NDA remains the baseline for authorized manufacturing.
What Orange Book listings generally show for a brand topical
- Active ingredient and dosage form: pimecrolimus 1% cream.
- Listed patents (if any) covering composition, formulation, or use.
- Any periods of exclusivity tied to the NDA filing and approvals.
What this implies for new suppliers
- If the NDA is still protected, generic manufacturers may avoid launch.
- The brand can still change manufacturing suppliers via supplements, subject to FDA approval and quality system readiness.
Which companies have FDA-approved generic or ANDA pathways for pimecrolimus cream?
Answer: Generic or “therapeutic equivalent” competition depends on whether ANDAs exist and whether they qualify for approval. For topical immunomodulators, the market can remain brand-dominant if no approved generic products exist.
How to map competitor suppliers for competitive intelligence
- Identify approved ANDA products for pimecrolimus 1% cream (if any).
- Pull the labeler/manufacturer statements for each.
- Compare finished dosage form manufacturers and packaging sites.
What patent and exclusivity timelines matter for ELIDEL supply and sourcing?
Answer: Patent and exclusivity affect whether additional firms can commercially supply competing products, not whether ELIDEL’s NDA holder can contract additional manufacturing sites for the brand.
What timing typically drives supply changes
- Manufacturing supplement approvals (CMC changes) after formulation or process scale changes.
- Site transfers after capacity planning or cost optimization.
- Stability requalification for new packaging or manufacturing site changes.
What litigation or settlements could constrain ELIDEL or generic supply?
Answer: Patent litigation and Paragraph IV settlements typically affect generic entry dates and approval schedules, which in turn changes competitive supplier landscape for pimecrolimus products.
What to monitor for supply-impact events
- Injunction or “carve-out” settlement terms limiting specific generic labels or strengths.
- Court decisions affecting patent scope (composition vs method-of-use).
- Consent decrees changing approval timelines.
How does ELIDEL compare with other topical calcineurin inhibitors on supplier strategy?
Answer: Comparing supplier strategies across topical calcineurin inhibitors (e.g., tacrolimus topical brands and generics) helps model how companies structure contract manufacturing and packaging. The supplier facts for ELIDEL, however, remain label- and FDA-record driven.
Typical cross-product supplier patterns
- One or two global API sources feeding multiple finished-product sites.
- Finished-product manufacturers vary by region and regulatory changes.
- Packaging and labeling often remain centralized even when manufacturing sites move.
Key Takeaways
- ELIDEL supplier identification is anchored to the FDA-approved label statements for drug product manufacture and to FDA establishment registration for manufacturing sites.
- ELIDEL contract manufacturing is typically the entity named in “Manufactured for” on the U.S. labeling, with actual site details reflected in FDA registration records.
- API supplier names for pimecrolimus may not be visible in consumer-facing labeling, but they are addressed in NDA CMC documentation for the approved finished product.
- Orange Book status and patent/exclusivity timelines control generic competition and therefore competitive supplier entry, while the brand NDA holder can change manufacturing suppliers through approved CMC supplements.
FAQs
1) Who is the NDA holder for ELIDEL (pimecrolimus 1% cream) and what does that imply for sourcing?
2) How can I identify the finished dosage form manufacturer for ELIDEL on the package labeling?
3) Do ELIDEL lots come from multiple manufacturing sites, and how is that reflected in FDA records?
4) Is there an FDA-approved generic or ANDA for pimecrolimus 1% cream that lists alternate manufacturers?
5) Do ELIDEL patent listings in the Orange Book list manufacturing-related patents or formulation patents that constrain competitors?
References
No citations included because no source documents (FDA label text, Orange Book record, or FDA registration extracts) were provided in the prompt.
