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Suppliers and packagers for CONTRAVE
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CONTRAVE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063 | NDA | Nalpropion Pharmaceuticals LLC | 51267-890-07 | 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-07) | 2014-10-22 |
| Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063 | NDA | Nalpropion Pharmaceuticals LLC | 51267-890-99 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-99) | 2014-10-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for CONTRAVE
Who Supplies CONTRAVE’s Key Components and Manufacturing?
CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride extended-release) is supplied through a defined US commercial supply chain that combines branded product manufacturing with specialized API and excipient sourcing. The drug’s supply structure is built around (1) controlled-release formulation technology, (2) two active pharmaceutical ingredients (APIs), and (3) US-market regulatory documentation that identifies the application holder and key manufacturing roles.
What entity is tied to CONTRAVE’s commercial supply in the US?
CONTRAVE’s application is held by Orexigen Therapeutics, Inc. (historical US label-holder; company name shown on US prescribing and regulatory records). The product is marketed in the US under the trade name CONTRAVE with naltrexone HCl/bupropion HCl extended-release in fixed-dose combination. The label identifies the drug’s composition, dosage forms, and the regulatory basis for the marketing authorization. (Source: FDA label for CONTRAVE). [1]
What APIs does CONTRAVE require?
CONTRAVE contains two APIs:
- Naltrexone hydrochloride
- Bupropion hydrochloride extended-release
(Source: FDA label for CONTRAVE). [1]
This matters for supplier mapping because each API has its own upstream supply: API manufacturers, salt/polymorph control, and release-spec-driven blending into a controlled-release final dosage form.
Who supplies the final dosage form manufacturing?
What does the US label say about manufacturing responsibility?
The US Prescribing Information documents the drug product identity and regulatory context, but it does not, within the core label sections, list the full vendor-by-vendor manufacturing roster in a way that is complete for “suppliers” in the procurement sense. The public label is still the anchor for legal supply-chain mapping because it locks the marketed composition and product form used by distribution channels. (Source: FDA label for CONTRAVE). [1]
Vendor-level supplier names for the finished-dose product (site-by-site contract manufacturing organization) are not provided in the label itself. They are instead typically located in FDA facility registries (Drug Establishment Registration and listing), drug application manufacturing sections (Module 3), and import/export declarations, none of which are included in the single label document.
Who supplies the APIs and controlled-release excipients?
What can be stated from public label composition about API and excipient supply?
Public label documentation confirms the drug’s actives and the fact that bupropion is present as an extended-release component. That implies:
- controlled-release formulation requires specialized excipients and release-controlling components; and
- the supplier pool spans API producers and controlled-release formulation component suppliers.
The label itself is the authoritative public record for actives and dosage form, but it does not enumerate excipient vendors by name. (Source: FDA label for CONTRAVE). [1]
As a result, only API identities can be stated with certainty from the label text, not specific upstream supplier companies.
How to interpret “suppliers” for CONTRAVE in procurement terms
What supplier categories matter for CONTRAVE sourcing?
For a fixed-dose combination with controlled release, procurement “supplier” mapping splits into four categories:
- API supplier for naltrexone HCl
- API supplier for bupropion HCl extended-release
- Controlled-release formulation component supply (excipients that enable extended-release performance)
- Finished-dose manufacturer / packer (tablet manufacture, coating, imprinting, packaging)
Only category (1) and (2) are explicitly named at the “what API” level in the publicly available label record; category (3) and (4) require site-specific regulatory files or facility listings. (Source: FDA label for CONTRAVE). [1]
CONTRAVE regulatory reference points that define the supply chain
What formal record pins the product to regulatory and manufacturing oversight?
- FDA Prescribing Information for CONTRAVE confirms the marketed product composition (naltrexone HCl + bupropion HCl extended-release) and indicates the regulated dosage form used for US distribution. (Source: FDA label for CONTRAVE). [1]
This is the only source in the provided dataset that supports direct, named-ingredient-level claims about supply inputs.
Key facts summary
| Category | CONTRAVE requirement | What can be evidenced from label/public record provided |
|---|---|---|
| APIs | Naltrexone hydrochloride | Confirmed in label [1] |
| APIs | Bupropion hydrochloride extended-release | Confirmed in label [1] |
| Finished-dose manufacture | Tablet + extended-release formulation | Not vendor-named in provided label text [1] |
| Excipient vendors | Controlled-release excipients and formulation components | Not vendor-named in provided label text [1] |
Key Takeaways
- CONTRAVE is a fixed-dose combination of naltrexone HCl and bupropion HCl extended-release. [1]
- The publicly provided FDA label record supports the ingredient and dosage-form identity, but it does not name specific supplier companies for finished-dose manufacturing or upstream excipients.
- For procurement-level “supplier” identification beyond API identities, supplier names must come from facility-registration/listing and application manufacturing sections, not the label.
FAQs
1) What are CONTRAVE’s active ingredients?
CONTRAVE contains naltrexone hydrochloride and bupropion hydrochloride extended-release. [1]
2) Is CONTRAVE a single-API product or a combination?
It is a two-API combination product: naltrexone HCl plus bupropion HCl in an extended-release form. [1]
3) Does the CONTRAVE label list specific manufacturer or supplier companies?
The label confirms composition and regulatory identity but does not provide a complete vendor-by-vendor procurement list for manufacturing sites or excipient suppliers in the provided record. [1]
4) Why does “extended-release” matter for sourcing?
Extended-release requires formulation performance with controlled-release components, which affects excipient and manufacturing process qualification. [1]
5) Where is the authoritative record for CONTRAVE formulation?
The FDA Prescribing Information is the anchor for formulation identity and regulated dosage form. [1]
References
[1] U.S. Food and Drug Administration. CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride) tablets, extended-release: Prescribing Information. FDA label document.
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