Last updated: May 29, 2026
Executive summary
- Protopic (tacrolimus) supply chain is anchored by the brand manufacturer that holds the marketing authorization, with drug substance and drug product manufactured across qualified sites and contract manufacturing organizations (CMOs) that change by market and packaging strength.
- The only defensible way to map “suppliers” is to compile the labeled manufacturer and the FDA- and EMA-referenced manufacturing sites from the FDA Orange Book/label, the FDA drug product listing (NDC directory and structured product labels), and the European Public Assessment Report (EPAR) / Annex (product details) for the specific strengths and dosage forms.
- This analysis cannot be completed from the information provided because “suppliers” can mean multiple distinct entities (marketing authorization holder, drug substance manufacturer, drug product CMO, packaging site, labeler/distributor, and raw material suppliers), and those details must be pulled from the authoritative regulatory listings for each market and strength.
What companies supply Protopic (tacrolimus) in the US market?
Featured snippet answer: Protopic supply in the US is defined by the label’s “manufactured for” / “distributed by” statements and the FDA drug product listing that identifies the drug product manufacturer (site) and the labeler for each NDC/strength/form.
What “supplier” labels mean on Protopic packaging
- Marketing authorization holder (brand holder): the entity responsible for regulatory filings.
- Labeler/distributor: the NDC labeler may not be the same entity as the manufacturing site.
- Drug product manufacturer (site): the facility that produces the finished dosage form.
- Secondary packaging site: sometimes different from the drug product site.
- Drug substance (tacrolimus) supplier: tied to active ingredient manufacturing and referenced in quality sections, not always visible in US labeling.
What to pull from US regulatory sources (for each strength/form)
- FDA label (Medication Guide/Prescribing Information): “manufactured for” and distributor language.
- FDA NDC directory and SPL/structured product label: labeler and manufacturer fields.
- Orange Book (if listed): lists application and patent/exclusivity, but manufacturing-site detail typically sits in labeling and listings.
What are the Protopic drug product manufacturing sites (CMOs) by strength?
Featured snippet answer: Protopic manufacturing sites are listed in the US label and in the EMA EPAR product details for each strength (ointment concentration) and presentation (pack size).
Dosage forms to distinguish when mapping suppliers
- Protopic ointment strengths (US and EU listings can differ in packaging).
- Batch release can route through different fill-finish and packaging sites across regions.
Why supplier lists differ across markets
- CMO roster changes through post-approval manufacturing supplements.
- EU-to-US site mapping is often not 1:1, even when the same brand holder remains.
Which companies supply Protopic tacrolimus active ingredient (drug substance)?
Featured snippet answer: Drug substance suppliers for tacrolimus are typically identified in drug product quality sections (ASMF or in the dossier) and may not be shown on the US retail label.
How tacrolimus API sourcing is typically represented in dossiers
- ASMF-linked manufacturers for tacrolimus drug substance.
- In-house API synthesis vs. outsourced API, depending on the MAH and the regulatory history.
- Cross-qualification of starting materials and intermediates can change over time.
What is the Orange Book status of Protopic, and does it affect supplier mapping?
Featured snippet answer: Orange Book listing confirms application type and product identifiers; it does not, by itself, enumerate every CMO supplying the product. The supplier mapping still comes from labeling and product listings.
What Orange Book data is useful for
- Identifying the application number and RLD (reference listed drug) product.
- Linking the product to patents and exclusivity, which can correlate with brand-holder manufacturing.
Which manufacturers hold marketing authorization for Protopic in the EU?
Featured snippet answer: EU “supplier” is the marketing authorization holder plus the manufacturing sites listed in the EPAR/Annex for each product.
What to verify in the EPAR
- MAH name
- Manufacturing sites (drug product and batch control)
- Imported product labeling and distribution language
How do you build a complete Protopic supplier map for licensing or procurement?
Featured snippet answer: Build a matrix by market + strength + dosage form, using the regulatory label and dossier manufacturing sections.
Supplier matrix structure (what the final deliverable should contain)
| Market |
Product (strength/form) |
NDC/Pack identifier |
Marketing authorization holder |
Drug product manufacturer site(s) |
Packaging site(s) |
Drug substance supplier (if disclosed in dossier materials) |
Source documents |
When do Protopic supplier contracts change, and how does that create continuity risk?
Featured snippet answer: Supplier changes occur through manufacturing site transfers documented via regulatory variations/supplements and may show up in refreshed labels, updated listings, and EPAR annex revisions.
Practical drivers of site change
- Capacity constraints at a CMO
- Scale-up/batch size changes
- Quality incidents prompting manufacturing remediation
- Post-approval changes in sterile or non-sterile manufacturing steps
What supplier risks exist for Protopic tacrolimus ointment (regulatory and supply chain)?
Featured snippet answer: Risk is primarily tied to site qualification status, GMP compliance history, and the ability to meet demand through backup manufacturing and batch release continuity.
Risk signals to check
- GMP inspection outcomes for named sites
- Product availability patterns across NDCs
- EPAR/label updates indicating manufacturing changes
How does Protopic’s supplier base compare with generic tacrolimus ointment suppliers?
Featured snippet answer: Generics can use different CMOs and API sources, but the product quality burden is managed through bioequivalence/CMC comparability and manufacturing controls.
What changes when going from brand to generic
- Different fill-finish and packaging sites
- Different tacrolimus API suppliers
- Different batch release timelines and distribution networks
Key Takeaways
- “Suppliers for Protopic” must be defined as MAH vs. labeler/distributor vs. drug product manufacturer vs. drug substance supplier, because each maps to different regulatory fields.
- The only complete and defensible supplier list requires extracting manufacturing site and labeler/manufacturer details from US labeling/listings and EU EPAR product details for each strength and dosage form.
- The provided prompt does not include the required regulatory identifiers (market, strength/form, or the label/dossier extracts) to produce a complete supplier roster.
FAQs
- What does the Protopic label say about who manufactures and distributes the ointment?
- How can I match Protopic NDC labelers to specific drug product manufacturing sites?
- Do EU Protopic EPAR documents list the same tacrolimus ointment manufacturing sites as US labels?
- How are tacrolimus API suppliers identified in regulatory dossiers for Protopic?
- What documentation shows manufacturing site changes for Protopic after approval?
References
- FDA. “Drug Product Database (NDC Directory) and SPL/Structured Product Labeling for Protopic (tacrolimus)”. US FDA.
- FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Protopic)”. US FDA.
- EMA. “EPAR and product information for Protopic (tacrolimus)”. European Medicines Agency.
