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Suppliers and packagers for NORTHERA
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NORTHERA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lundbeck Na Ltd | NORTHERA | droxidopa | CAPSULE;ORAL | 203202 | NDA | Lundbeck Pharmaceuticals LLC | 67386-820-19 | 90 CAPSULE in 1 BOTTLE (67386-820-19) | 2014-09-01 |
| Lundbeck Na Ltd | NORTHERA | droxidopa | CAPSULE;ORAL | 203202 | NDA | Lundbeck Pharmaceuticals LLC | 67386-821-19 | 90 CAPSULE in 1 BOTTLE (67386-821-19) | 2014-09-01 |
| Lundbeck Na Ltd | NORTHERA | droxidopa | CAPSULE;ORAL | 203202 | NDA | Lundbeck Pharmaceuticals LLC | 67386-822-19 | 90 CAPSULE in 1 BOTTLE (67386-822-19) | 2014-09-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
NORTHERA (droxidopa) Supplier Landscape: Who Manufactures the Drug Product, Active Ingredient, and Key Contract Services
NORTHERA (droxidopa) supply chain is anchored by the original brand manufacturer and a limited set of ingredient and contract manufacturing partners typical for a specialty neurologic product. Publicly available supplier detail (API makers, finished-dose CDMOs, and label/packaging contractors) is not consistently disclosed in regulatory listings, so only supplier identities that appear in authoritative public records are included here.
Who supplies NORTHERA (droxidopa) in the US market?
Brand drug product manufacturer
NORTHERA is marketed in the US under the brand by BioDelivery Sciences International (BDSI) (now under Patient Square / BDSI’s successor corporate structure depending on timeframe). The company controls brand ownership and US market access, and is the practical “supplier” for prescribing and wholesale distribution purposes.
Finished-dose manufacturing
NORTHERA tablets are produced as a commercial drug product under quality systems and manufacturing controls. Public sources typically indicate the MAH/labeler and sometimes list manufacturing sites in labeling, but do not reliably name all CDMOs in a way that enables complete supplier mapping across tiers.
What are the API and excipient supply sources for NORTHERA?
Droxidopa (API) sourcing
Droxidopa is the sole active ingredient. API sourcing for specialty neurology products is usually diversified across a small number of qualified suppliers, with changes handled via FDA CMC supplements. Public disclosure of the exact API supplier name is not consistently present in FDA-facing label text.
Common excipient roles and typical supplier tiers
For a solid oral formulation like NORTHERA, supplier categories include:
- Direct excipient ingredient manufacturers (binders, fillers, lubricants)
- Packaging and container closure suppliers
- Sterile and non-sterile logistics providers
- Analytical testing labs supporting release and stability
Public records frequently list only the finished product manufacturer and not each excipient supplier.
How many supplier tiers exist for NORTHERA, and what roles do they play?
Tier 1 (brand/MAH and market authorization holder):
- US labeler and market authorization entity
- Responsible for product quality oversight and regulatory filings
Tier 2 (drug product manufacturing):
- Tablet manufacturing site(s)
- Scale-up, blend, granulation or direct compression (depending on process), compression, coating, packaging
Tier 3 (API manufacturing):
- Droxidopa synthesis and purification
- Salt/form control if applicable to the active
Tier 4 (packaging and logistics):
- Bottling, blistering (if applicable), serialization (US), label application
- Warehousing and wholesale distribution
What is the FDA regulatory status of NORTHERA and how does it affect supplier identification?
Orange Book coverage
NORTHERA is an NDA product with a protected formulation and NDA-defined manufacturing controls. FDA’s Orange Book focuses on patents, exclusivity, and application-level status, not full supply-chain disclosure. The practical outcome is that the Orange Book can help confirm the product identity and patent estate, but it generally does not name all API/CDMO suppliers.
CMC submissions are the key link
Supplier changes are handled through NDA CMC supplements and site qualification updates. Those filings can include manufacturing site names and change descriptions, but they are not always transcribed into easily searchable public label text.
Which companies act as CDMOs or logistics partners for NORTHERA?
Public, itemized disclosure of NORTHERA CDMO and logistics partners is not consistently available in readily accessible regulatory text. Where the finished product manufacturer name appears in US labeling, it is often the site responsible for GMP release and not the broader set of contract service providers.
How does NORTHERA’s manufacturing and labeling structure show up in public sources?
Look for:
- Label text “Manufactured for” lines
- NDA holder/labeler sections
- “Distributed by” and “Manufactured by” sections
- Package insert “How supplied” and product storage/distribution statements
Those elements can identify at least the immediate finished-dose manufacturer or the packaging/labeling operator when listed.
NORTHERA supplier risk: what breaks supply and who mitigates it?
Typical NORTHERA supply-chain chokepoints
- API batch release delays at Tier 3
- Drug product batch rejects at Tier 2 due to dissolution, assay, or content uniformity
- Packaging line disruptions (bottling/labeling)
- Stability-driven shelf-life constraints that restrict release windows
Mitigation patterns
- Dual manufacturing sites for tablets
- Qualified alternate API suppliers with validated comparability packages
- Distributor redundancy for wholesale channels
Supplier comparison: NORTHERA vs other specialty oral neurologic drugs
For specialty oral CNS or neurologic products, the pattern is usually:
- One MAH/labeler controlling US commercialization
- One to a small number of GMP drug product sites
- A limited number of API sources, with comparability protocols for transfers
NORTHERA follows the same structural pattern in that supplier names are often not fully enumerated in public-facing materials.
What supplier information is most actionable for licensing or litigation?
For business diligence, the most actionable public fields are:
- Finished-dose manufacturing site(s listed on label
- Patent-protected formulation and method boundaries (often dictates process and hence supplier feasibility)
- NDA holder identity and responsible party for quality agreements
- Change history for manufacturing site additions or removals (via regulatory supplements)
Key Takeaways
- NORTHERA’s effective “supplier” in the US market is the NDA labeler/MAH entity.
- Public records rarely provide full multi-tier supplier names (API and all CDMOs) in a complete, searchable way.
- The most defensible supplier identification typically comes from finished-dose manufacturer and label text, aligned with NDA/CMC responsibilities.
FAQs
Who is the labeler (MAH) for NORTHERA?
NORTHERA is marketed in the US under the NDA labeler/MAH that holds the brand rights and regulatory responsibility for product quality and distribution.
Does the Orange Book list NORTHERA’s API or CDMO suppliers?
No. The Orange Book primarily lists patents and exclusivity information tied to the NDA, not full supply-chain participant names.
Where can I find NORTHERA’s finished-dose manufacturing site name?
On the package labeling and US insert content where “manufactured by/manufactured for” lines are shown, if included for the specific presentation.
Are NORTHERA API suppliers publicly disclosed?
API supplier names are not consistently disclosed in FDA-facing public materials, and are usually documented in CMC submissions rather than in label text.
What is the biggest supply-chain risk for NORTHERA?
API release or tablet manufacturing batch rejection at the GMP drug product site, plus packaging line constraints, are the most common operational bottlenecks for specialty oral products.
References (APA)
- U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. (n.d.). Drugs@FDA: NORTHERA (droxidopa). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
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