Suppliers and packagers for LEVULAN

LEVULAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965	NDA	Sun Pharmaceutical Industries, Inc	67308-101-01	1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE	2000-09-04
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965	NDA	Sun Pharmaceutical Industries, Inc	67308-101-02	2 APPLICATOR in 1 CARTON (67308-101-02) / 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE	2000-09-04
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965	NDA	Sun Pharmaceutical Industries, Inc	67308-101-06	6 APPLICATOR in 1 CARTON (67308-101-06) / 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE	2000-09-04

Suppliers and packagers for LEVULAN

Last updated: May 26, 2026

Levulan (ALA HCl) Suppliers: Who Manufactures the Drug, API, and Key Components for Market Supply

Executive summary: Levulan Kerastick and related Levulan products are supplied through a defined manufacturing chain centered on 5-aminolevulinic acid (ALA) hydrochloride (HCl) drug substance and topical drug product manufacturing. Market supply is tied to the FDA listed-drug and Orange Book-linked manufacturers for each finished-dose presentation. Without the specific country/market and exact Levulan presentation (for example Levulan Kerastick vs other Levulan-labeled SKUs), a complete, accurate supplier mapping (API manufacturers, fill-finish, packaging line suppliers, and distribution wholesalers) cannot be produced from verifiable data.

What companies supply Levulan Kerastick in the US market?

Short answer: Levulan Kerastick supply in the US follows FDA drug listing: the entity listed as manufacturing site for drug product (and separate sites for labeler and drug substance when disclosed) is the primary “supplier” path used for sourcing and procurement. The same is true for any non-Kerastick Levulan presentation that exists in other regulatory catalogs.

Which Levulan presentations change the supplier list?

Supplier identity differs by:

• Finished dose form (stick applicator vs other topical packaging)
• Strength and concentration
• Package configuration (single unit vs multi-pack)
• Regulatory listing version (label revisions and NDC changes)

How to identify Levulan suppliers using high-confidence records

For US market diligence, suppliers should be confirmed via:

• FDA “Drugs@FDA” listing entries for each Levulan product/NDC
• FDA Orange Book listings for the listed drug product manufacturer(s)
• FDA SPL (Structured Product Labeling) “manufacturer” and “labeler” fields that map to current market authorization

Who supplies levulinic acid (5-aminolevulinic acid) hydrochloride (ALA HCl) for Levulan?

Short answer: The API “supplier” for Levulan is the manufacturer of 5-aminolevulinic acid hydrochloride (ALA HCl) used as drug substance. In practice, API supply is disclosed as drug substance manufacturer(s) in FDA labeling/registration data or inferred from the drug product manufacturing sites and cGMP disclosures tied to the registered establishments.

Common API-to-product supply chain patterns for topical ALA

Topical Levulan manufacture typically involves:

• ALA HCl synthesis and crystallization under GMP
• Drug substance testing (identity, assay, residual solvents/impurities)
• Drug product formulation and controlled moisture handling
• Aseptic or cleanroom-oriented filling depending on formulation and packaging design
• Applicator (“Kerastick”) filling, sealing, and secondary packaging

What is the Orange Book status of Levulan and how does that identify suppliers?

Short answer: Orange Book listings identify the listed drug and the patents tied to the drug product. The Orange Book listing also maps the applicant/holder and frequently the drug product manufacturer used for market entry and legal referencing. That is the most direct public anchor for supplier identification that matters for licensing and regulatory work.

Why Orange Book data is supplier-critical

For supply diligence, Orange Book provides:

• The listed drug identity
• The patent holder/applicant
• The connection to the approved drug product used in FDA regulatory submissions
• A stable reference point for which finished product is being manufactured under which regulatory authorization

Which manufacturers are listed for Levulan drug product manufacturing and labeling?

Short answer: Levulan supplier lists depend on the current FDA labeler and manufacturing establishment per NDC. These details are recorded in FDA registration and product listing systems and can be retrieved for:

• Each Levulan presentation
• Each NDC
• Each country-specific regulatory authorization

Data fields used to build an auditable supplier map

• Labeler (legal entity holding the marketing authorization)
• Applicant (if separate from labeler)
• Drug product manufacturer (establishment)
• Drug substance manufacturer (when disclosed)
• Packager / repackager (where applicable)
• Distributor / logistics partner (often not public unless shown in labeling or regulatory files)

What formulations are protected for Levulan and who supplies the protected product?

Short answer: Levulan is protected by formulation and use-related patent estate elements tied to the approved topical ALA presentation and its light-activation use. Supplier identity is determined by the approved, protected product being manufactured under the relevant cGMP authorization.

How formulation patents affect supplier sourcing

When formulation and process patents are active:

• Competitors may be restricted from sourcing/producing equivalent topical products
• Contract manufacturing must remain within licensed scope for the specific approved formulation and process

When does Levulan lose exclusivity and what supplier entry risks appear?

Short answer: Exclusivity loss and patent expiration timelines govern when additional manufacturers can enter with lawful reference products or biosimilar-equivalent constructs (not applicable to ALA topical in the usual biologics sense). Entry risk is primarily about generic/topical equivalents and Paragraph IV-type challenges where relevant patent frameworks exist.

Entry risk drivers for Levulan supply

• Whether patents covering the specific Levulan presentation remain active
• Whether any supplier can lawfully manufacture a non-infringing alternative
• Whether FDA has approved any alternative ALA topical products with different NDCs

What generic or alternative ALA topical products compete with Levulan and who supplies them?

Short answer: Competitive risk is tied to the market presence of ALA topical generics/alternatives approved to the same intended use. Supplier identity for competitors is again determined by their FDA product listings and Orange Book entries.

How to compare supplier estates vs Levulan

For each competitor:

• Identify the labeler/manufacturer(s)
• Map the drug product manufacturing sites
• Align patent estate scope to see whether competitors rely on:
  • different formulations
  • different delivery systems
  • different method-of-use or dosing regimens

What patent litigation affects Levulan supply contracts and supplier selection?

Short answer: Litigation affects which manufacturers can supply the product without triggering injunction risk or licensing obligations. For ALA topical products, the key is whether any active patent disputes target the specific Levulan listed patents or the approved formulation/process.

How to use litigation dockets to find “real” suppliers

• Settlement agreements often name manufacturing and distribution entities indirectly via parties and licensing entities
• Injunctions constrain specific production chains tied to particular establishments and applications

What is the FDA regulatory status of Levulan and which suppliers can legally manufacture it?

Short answer: Levulan’s FDA approval defines the set of legally recognized manufacturing establishments via FDA registration and labeling. Only entities operating within those approved establishments for the authorized product can market supply under that authorization (or under an alternative approval path for comparable products).

Key Takeaways

• Levulan supplier identification is presentation-specific (Kerastick vs other SKUs) and NDC-specific.
• The most reliable public anchor for supplier mapping is FDA Drugs@FDA and Orange Book product and patent listing records.
• A complete supplier map requires linking the drug product manufacturer(s) and any drug substance manufacturer(s) disclosed for the specific authorized presentation.
• Patent and exclusivity status determines which additional suppliers can enter without legal or regulatory constraint.

FAQs

1. How do I identify Levulan suppliers by NDC and FDA labeler?
2. Which FDA database fields list Levulan drug product manufacturing establishments?
3. Does Levulan’s supplier chain include ALA HCl drug substance manufacturers, or only finished-dose sites?
4. What role do Orange Book patents play in identifying who can supply Levulan equivalents?
5. How do changes in Levulan packaging (stick vs other configurations) affect supplier mapping?

References

1. U.S. Food and Drug Administration. Drugs@FDA database. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/