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Suppliers and packagers for SANDOSTATIN LAR
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SANDOSTATIN LAR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008 | NDA | Novartis Pharmaceuticals Corporation | 0078-0811-81 | 1 KIT in 1 KIT (0078-0811-81) * 6 mL in 1 VIAL (0078-0790-61) * 2 mL in 1 SYRINGE | 2016-07-22 |
| Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008 | NDA | Novartis Pharmaceuticals Corporation | 0078-0818-81 | 1 KIT in 1 KIT (0078-0818-81) * 6 mL in 1 VIAL (0078-0797-61) * 2 mL in 1 SYRINGE | 2016-07-22 |
| Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008 | NDA | Novartis Pharmaceuticals Corporation | 0078-0825-81 | 1 KIT in 1 KIT (0078-0825-81) * 2 mL in 1 SYRINGE * 6 mL in 1 VIAL (0078-0804-61) | 2016-07-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for SANDOSTATIN LAR
Who Supplies SANDOSTATIN LAR (octreotide) Globally?
SANDOSTATIN LAR is an intramuscular (IM) sustained-release formulation of octreotide acetate (long-acting release) marketed in multiple countries. The drug’s commercial supply chain is anchored by the originator/brand owner for SANDOSTATIN (Novartis) and the company’s licensed manufacturing network for finished product and key intermediates.
Brand owner and commercial supply control
| Role | Entity | What they supply / control | Notes |
|---|---|---|---|
| Originator/brand owner | Novartis | Commercial rights and quality system oversight for SANDOSTATIN and SANDOSTATIN LAR | Brand operations run through country affiliates and distributors; manufacturing occurs via approved sites under Novartis control. |
| Marketing authorization holder (varies by country) | Novartis affiliates | Country-level regulatory responsibility for the listed product | The authorization holder is listed on local labels/SmPC for each market. |
What “supplier” means for SANDOSTATIN LAR
“Suppliers” in a pharmaceutical context typically breaks into three layers:
1) Finished-dose manufacturer (where the LAR drug product is produced and released),
2) Primary component suppliers (active pharmaceutical ingredient and major excipient/encapsulation components),
3) Distribution network (wholesalers/pharmacies per country).
Only the finished-dose manufacturing and API/major component layers materially affect R&D benchmarking and patent freedom-to-operate assessments.
Who manufactures SANDOSTATIN LAR finished drug product?
SANDOSTATIN LAR is produced under Novartis’ approved manufacturing network for long-acting octreotide acetate formulations. In regulatory dossiers, the finished-dose manufacturer is typically listed as one or more manufacturing sites responsible for production and batch release.
Manufacturing structure
| Manufacturing step | Typical supplier type | How it shows up in filings/labels |
|---|---|---|
| Drug product manufacturing (IM LAR) | Licensed finished-dose manufacturer (Novartis or contract manufacturer) | Listed on SmPC/label as “Manufactured by” / “Batch release site” |
| Sterile IM dose assembly and packaging | Same site or parallel packaging site | “Packaged by” and “Batch release” listings in local regulatory docs |
| Quality release and GMP batch disposition | Qualified person (QP) at release site | “Batch release” location in regulatory records |
Actionable implication: for supplier due diligence, treat the finished-dose manufacturer(s) as the primary “supply” node because they control formulation process, particle/suspension characteristics, and release testing.
Who supplies the active ingredient (octreotide acetate) and major components?
SANDOSTATIN LAR contains octreotide acetate as the active ingredient, plus a sustained-release matrix system consistent with LAR technology (suspension in microsphere-type delivery format).
API and component supply categories
| Layer | Supplier type | Common evidence used in due diligence |
|---|---|---|
| API: octreotide acetate | API manufacturer under Novartis supply chain or approved alternate sites | CoA and regulatory listing of manufacturer for API in dossiers |
| LAR matrix system components | Excipient/microsphere-related suppliers used by the drug product manufacturer | Often shown indirectly through manufacturing formulas in dossiers |
| Primary packaging | Packaging/label supplier ecosystem | “Packaged by” entries on local labels and regulatory submissions |
Actionable implication: for competitive intel (cost, lead times, sourcing risk), focus on (a) API release testing site and (b) the drug product batch release site, not just the brand owner.
What is known from public regulatory and product information sources?
Public product databases and regulatory label references consistently identify:
- Novartis as the brand owner/marketing entity for SANDOSTATIN LAR, and
- the local manufactured by / batch released by / packaged by entities per country.
However, a precise, market-agnostic list of specific supplier companies (named finished-dose sites and named API sites) requires pulling each country’s SmPC/label text and mapping the listed manufacturing sites to the same entities across markets.
Given the constraint that only complete and accurate information should be provided, this response limits itself to the verifiable structure: Novartis controls commercial supply and quality oversight, with finished-dose and batch release executed at approved manufacturing sites that are listed in each market’s labeling.
Why supplier identification differs by country
SANDOSTATIN LAR is supplied through:
- country-specific marketing authorization holders, and
- country-specific distributor and warehouse networks, and
- potentially country-specific packaging or release routes.
So, the “supplier” name a customer sees (labeling/ordering) can differ from the underlying manufacturing site.
Example: how “supplier” appears on labels
Local product labeling typically includes fields such as:
- “Marketing authorization holder: Novartis … (country affiliate)”
- “Manufacturer: … (site name and address)”
- “Batch release: … (site name)”
- “Packaged by: …”
This is the operational supplier list used for procurement and contract manufacturing compliance.
Procurement-ready supplier map (what you can act on now)
| Procurement need | Supplier node to target | Source to validate in practice |
|---|---|---|
| Identify who releases batches | Batch release site listed on local SmPC/label | Local label/SmPC for each strength (10 mg / 20 mg / 30 mg) |
| Identify who makes the IM LAR | Finished-dose manufacturer listed on local SmPC/label | Local label/SmPC manufacturing section |
| Identify who controls octreotide API | API manufacturer listed in regulatory dossiers or by API CoA source | Novartis API supply documentation and filings |
| Identify distribution channel | Authorized wholesalers / distribution partners | Local tender/distributor listings for each country |
Key Takeaways
- Novartis is the brand owner and commercial quality/oversight anchor for SANDOSTATIN LAR.
- The operational “supplier” for R&D and compliance purposes is the finished-dose manufacturer and batch release site named in each country’s SmPC/label.
- The octreotide acetate API and LAR matrix system components are sourced through the approved manufacturing network feeding those batch release sites.
- Supplier names in procurement documentation can vary by market due to local labeling, packaging, and release routing.
FAQs
1) Who is the supplier of SANDOSTATIN LAR?
Novartis controls the brand and manufacturing oversight, while the finished-dose manufacturer and batch release site are specified on each country’s SmPC/label.
2) Is the manufacturer the same worldwide?
Not necessarily. Packaging and batch release routes can vary by country, even if the brand owner stays the same.
3) Who supplies the active ingredient octreotide acetate?
Octreotide acetate is supplied through the approved Novartis/contract API supply network feeding the LAR manufacturers; the exact API supplier is listed in regulatory documentation and confirmed via batch documentation.
4) What suppliers matter most for quality and process intel?
The finished-dose manufacturing site and the QP batch release site matter most because they define formulation execution and release specifications.
5) Where do you find the named supplier companies?
In the manufacturing and marketing authorization sections of each country’s local SmPC and product label for SANDOSTATIN LAR.
References
[1] Novartis. SANDOSTATIN LAR (octreotide acetate) product information and regulatory documentation (varies by country).
[2] European Medicines Agency (EMA). SANDOSTATIN LAR EPAR and associated product documentation (manufacturing and batch release details may require country label mapping).
[3] U.S. FDA. Approved drug labeling and reference product information for octreotide acetate long-acting release products (labeling sections may list manufacturer and packaging information).
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