Suppliers and packagers for SOMATULINE DEPOT

SOMATULINE DEPOT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074	NDA	Ipsen Biopharmaceuticals, Inc.	15054-1060-4	1 POUCH in 1 CARTON (15054-1060-4) / 1 SYRINGE in 1 POUCH / .2 mL in 1 SYRINGE	2007-11-14
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074	NDA	Ipsen Biopharmaceuticals, Inc.	15054-1090-4	1 POUCH in 1 CARTON (15054-1090-4) / 1 SYRINGE in 1 POUCH / .3 mL in 1 SYRINGE	2007-11-14
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074	NDA	Ipsen Biopharmaceuticals, Inc.	15054-1120-4	1 POUCH in 1 CARTON (15054-1120-4) / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE	2007-11-14

SOMATULINE DEPOT Suppliers: Who Manufactures, Fills, and Supplies Lanreotide Depot in the US and EU

Last updated: May 26, 2026

Executive summary

• SOMATULINE DEPOT (lanreotide acetate) depot is supplied through a global manufacturing and supply chain anchored by Ipsen as the brand owner and commercial supplier.
• The supply base typically includes (1) API manufacture, (2) depot-formulation drug product manufacture, and (3) sterile/controlled fill-finish and packaging performed by a mix of Ipsen sites and contract manufacturing organizations (CMOs), with site responsibilities varying by market (US vs EU) and strength/formulation batch.
• For definitive supplier attribution by site and dosage strength, the controlling sources are FDA Orange Book drug-product listings (for US) and EMA product information and manufacturing authorizations (for EU), which tie drug product strength to specific manufacturing sites and marketing authorization holders.

Who are the suppliers for SOMATULINE DEPOT (lanreotide depot) in the US?

Short answer: Ipsen supplies SOMATULINE DEPOT as the listed labeler/marketer in the US; specific manufacturing sites for each dosage strength and package configuration are identified via FDA drug listing and Orange Book references.

What does “supplier” mean for a depot like SOMATULINE DEPOT?

For depot injectables, supplier mapping usually splits into:

• Marketing authorization holder / labeler (brand supply responsibility)
• API supplier (lanreotide acetate manufacture)
• Drug product manufacturer (depot formulation and sterilized injectable manufacture)
• Fill-finish and packaging site(s)
• Secondary pack and distribution logistics

What is the controlling US reference to map SOMATULINE DEPOT suppliers?

• FDA Orange Book listings identify the drug product and reference the application and manufacturing information reflected in the FDA database.
• FDA label (Prescribing Information) also lists the manufacturer and may include multiple manufacturing and packaging locations.

What suppliers produce lanreotide acetate (API) for SOMATULINE DEPOT?

Short answer: API manufacture is handled through Ipsen’s supply chain and/or qualified CMOs; the definitive supplier identity is the named API manufacturer in the FDA/EMA manufacturing authorization chain tied to SOMATULINE DEPOT batches and application references.

How to interpret API supplier listings for lanreotide depot

Lanreotide depot is not a simple solution formulation. API supply is typically coupled to:

• Specific polymorph and particle specifications for the depot drug substance
• Controlled release performance requirements for the final microparticle or depot matrix
• Manufacturing control strategies that limit interchangeability of API sources

Manufacturing structure typically used for depot injectables

• Drug substance (lanreotide acetate): produced under pharmaceutical-grade GMP with validated impurity profiles
• Depot drug product: typically a long-acting injectable with a controlled release matrix and depot-specific critical quality attributes
• Fill-finish: often performed in a limited number of high-control sterile injectable facilities

Which companies manufacture and fill SOMATULINE DEPOT drug product (depot injection)?

Short answer: The drug product is manufactured under Ipsen’s marketing and quality system, with manufacturing and packaging often performed at Ipsen facilities and, for some steps, at contract sterile/injectable CMOs.

Dosage strengths change the manufacturing footprint

Depot formulations are supplied across strengths (commonly including the 60 mg/90 mg/120 mg range in markets). In practice:

• Each strength can map to a different drug product manufacturing site and sometimes different fill-finish lots
• Orange Book entries and EU manufacturing authorizations can show distinct sites per strength

Where to see the exact manufacturing sites

• FDA product listing and Orange Book records for SOMATULINE DEPOT
• EMA EPAR and product manufacturing authorization disclosures (by strength and presentation)

What manufacturing sites supply SOMATULINE DEPOT in the EU?

Short answer: Ipsen is the marketing authorization holder in many EU markets; manufacturing sites are identified in the EU product dossier and manufacturing authorization documents for the specific product strength and presentation.

How EU supplier identification works for depot injectables

For EU products, supplier mapping relies on:

• Marketing authorization holder (MAH)
• Manufacturer of the finished product
• Manufacturer of the active substance
• Batch release site (where described)
• Packaging site(s)

Why EU and US supplier sets can differ

Depot injectables are distributed by geography and regulatory supply chains:

• US labeling and approvals can point to different sites than EU manufacturing authorizations
• Batch release and packaging can shift based on capacity constraints and seasonal demand

Is SOMATULINE DEPOT supplied by a single contract manufacturer or multiple CMOs?

Short answer: Depot injectable supply chains commonly use multiple sites for redundancy. The precise answer for SOMATULINE DEPOT depends on the specific strength and jurisdiction as reflected in Orange Book and EMA manufacturing documents.

Typical multi-site patterns for long-acting depots

• Primary drug product manufacturing site plus backup sites
• Separate facilities for sterile assembly vs packaging
• Quality release performed by specialized batch release units

What is the Orange Book status of SOMATULINE DEPOT and what does it imply for supplier mapping?

Short answer: SOMATULINE DEPOT’s Orange Book listings define the approved drug product and can be used to tie the product to its application and referenced manufacturing information.

How Orange Book data supports supplier identification

• Orange Book contains drug product identifiers and can link to patent and exclusivity records, and the FDA labeler and sometimes manufacturing information by configuration.
• It is the fastest regulatory data source to connect a named depot to the FDA-defined product record.

What generic or biosimilar competition exists for SOMATULINE DEPOT, and does it change supplier risk?

Short answer: Competition is constrained by lanreotide depot’s approved-drug exclusivity and patent landscape. If no approved generic depot equivalents exist, supplier risk remains primarily tied to drug product manufacturing continuity rather than product switching.

How to read competition risk for depot injectables

Supplier exposure in mature specialty injectables typically comes from:

• Site-specific capacity
• Sterile injectable and depot matrix manufacturing bottlenecks
• Raw material constraints for the active and depot excipients
• Regulatory variance (if a manufacturer changes or supplements are filed)

Key takeaways

• Ipsen is the core supplier for SOMATULINE DEPOT as the brand owner and commercial labeler in the approved markets.
• Supplier mapping down to API and drug product manufacturing sites must be anchored to FDA Orange Book/product listings (US) and EMA manufacturing authorizations (EU), because depot injectables often use multiple sites by strength and presentation.
• For supply-chain planning, the practical risk is multi-site dependency and site-specific batch release capacity, not only brand ownership.

FAQs

1) Who is the labeler/marketer of SOMATULINE DEPOT in the US?
SOMATULINE DEPOT is supplied in the US under the brand label and approval record controlled by Ipsen. (US specifics are verified via FDA drug listing/Orange Book.)

2) Can lanreotide API be sourced from multiple suppliers for SOMATULINE DEPOT?
Yes in practice many complex injectables maintain approved alternative sources. The authorized API supplier list is determined by the regulatory manufacturing chain for the specific product strength.

3) Do manufacturing sites for SOMATULINE DEPOT differ by strength?
Often yes. Depot products can be manufactured and released at different sites depending on strength and presentation, as reflected in FDA/EMA records.

4) Does Orange Book show manufacturing sites for SOMATULINE DEPOT?
Orange Book primarily anchors the approved drug product record and identifiers. Manufacturing site detail is typically corroborated with the FDA label and referenced manufacturing information in the application record.

5) What is the biggest supplier continuity risk for a long-acting lanreotide depot?
The biggest operational risk is drug product depot manufacturing and sterile-ready fill-finish capacity at the qualified GMP site(s), plus raw-material supply for depot formulation components.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA Orange Book database.
2. FDA. SOMATULINE DEPOT Prescribing Information and drug labeling (active ingredients: lanreotide acetate; depot injectable).
3. EMA. European public assessment reports (EPAR) and product information for SOMATULINE DEPOT (lanreotide acetate) for manufacturing authorization details by strength and presentation.