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Suppliers and packagers for librax
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librax
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bausch | LIBRAX | chlordiazepoxide hydrochloride; clidinium bromide | CAPSULE;ORAL | 012750 | NDA | Bausch Health US, LLC | 0187-4100-10 | 100 CAPSULE in 1 BOTTLE (0187-4100-10) | 1966-09-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
LIBRAX suppliers: Who manufactures, packages, and supplies chlordiazepoxide + clidinium in the US and EU
Who supplies LIBRAX (chlordiazepoxide and clidinium) to pharmacies and wholesalers?
Answer: LIBRAX is supplied by the brand manufacturer/marketer that holds FDA approval for the listed drug application (NDA) and its contract manufacturing and packaging network. In the US, the drug’s “labeler” and distributor identity is reflected in FDA’s Drug Approvals and Orange Book entries and in NDC directory listings (labeler, packager).
A complete, accurate supplier map requires the specific NDCs and the current labeler and manufacturer of record that correspond to those NDCs. Without NDC-specific identification, supplier attribution can be incorrect because LIBRAX strengths and dosage forms can be sourced through different manufacturing and packaging sites over time.
Which companies manufacture LIBRAX tablets (chlordiazepoxide HCl + clidinium bromide)?
Answer: Identify the manufacturer-of-record for each LIBRAX NDC strength and package size from the latest FDA Orange Book and the NDC Directory. Each NDC can list different “manufacturing sites” and sometimes different “labeler” entities, even when the active ingredients are unchanged.
Typical supply-chain roles that show up for LIBRAX
- NDA holder / labeler (US): Responsible for product on the market and compliance with cGMP and labeling.
- Finished dosage manufacturer: Produces the tablets, including blending and compression.
- Packaging and labeling: Bottling, blister packaging, carton labeling, and serialization.
- API manufacturers (upstream): Suppliers of chlordiazepoxide HCl and clidinium bromide to finished-dosage makers (often not listed publicly in a simple way).
- Wholesalers/distributors: Wholesale distribution is handled through large national chains and regional distributors, with the brand labeler supplying them.
What does the FDA Orange Book list for LIBRAX suppliers and patent coverage?
Answer: The Orange Book lists active ingredient, applicant (NDA holder), dosage form, strength, and patent information tied to that approved drug. Orange Book is the correct anchor for “who is the applicant/holder,” which is the starting point for identifying supplier responsibility.
What Orange Book does not reliably provide
- It may not enumerate API supplier names.
- It may not list every contract manufacturing or packaging subcontractor that participates in current production.
- It does not always provide site-level operational sourcing details beyond “applicant” and associated regulatory identifiers.
How many NDCs does LIBRAX have, and do they map to different manufacturers?
Answer: LIBRAX commonly has multiple NDC listings across strength and package configuration. In practice, different NDCs can correspond to:
- different packaging sites,
- different manufacturing sites,
- different labelers (especially when marketed under different legal entities or through repackagers).
A supplier analysis that targets “who supplies pharmacies” should map:
- NDC → 2) labeler → 3) manufacturer of record → 4) dosage form/strength.
Which distributors supply LIBRAX in the US wholesale channel?
Answer: Wholesale distribution typically runs through national wholesalers (and GPO-linked channels) that carry brand products. However, the specific distributor that supplies a particular pharmacy depends on the pharmacy’s purchasing arrangement, contract status, and inventory routing at the time of fulfillment.
A reliable “top distributors” answer must be derived from shipment and wholesaler inventory reporting or from current NDC product distribution data that ties NDCs to distributors.
Are generic equivalents of LIBRAX supplied by different manufacturers?
Answer: Yes. Generic chlordiazepoxide + clidinium equivalents are supplied by their own ANDA holders and their manufacturing networks. If a pharmacy substitutes, the supplier identity changes to the generic manufacturer (and its labeler), even though the active ingredients and dosage form match.
What suppliers support API production for chlordiazepoxide HCl and clidinium bromide?
Answer: Public, authoritative supplier attribution for the APIs is not consistently available without direct sourcing disclosures, regulatory filings that name suppliers, or procurement-level documentation. Finished dosage manufacturers often use multiple API suppliers and qualify them under their quality systems.
For a business-grade supplier list, the correct method is to extract:
- API manufacturer identifications from dmfs/Drug Master Files references (when publicly findable),
- supplier names from public procurement or regulatory documentation tied to the NDA/ANDA,
- and current commercial supply-chain statements from the finished dosage manufacturer.
Which contract manufacturers typically produce and package combination psychiatric antispasmodic products like LIBRAX?
Answer: Many combination products rely on contract manufacturing organizations (CMOs) and contract packaging organizations (CPOs). Identifying the specific CMOs/CPOs for LIBRAX requires NDC-level labeler/manufacturer-of-record site mapping and confirmation against cGMP facility registrations and product-specific manufacturing authorizations.
Without NDC-specific anchor data, naming CMOs/CPOs risks misidentification.
Key Takeaways
- “LIBRAX suppliers” must be defined at the correct level: NDA holder/labeler, finished dosage manufacturer, packaging site, and upstream API supplier.
- FDA Orange Book and NDC Directory mappings are the authoritative starting points for supplier-of-record identification.
- A complete supplier list is NDC-specific, because labelers and manufacturing/packaging sites can differ by strength and packaging configuration.
- Generic substitution changes the supplier network to the ANDA holder and its manufacturing partners.
FAQs
-
How do I identify the manufacturer-of-record for LIBRAX for a specific NDC?
Check the NDC Directory entry for that exact NDC, then cross-reference the applicant in FDA Orange Book for the corresponding dosage form and strength. -
Do different LIBRAX strengths come from different manufacturers?
They can. Supplier-of-record changes can occur by strength, package size, and over production cycles. -
Where can I see LIBRAX NDA holder and patent estate details?
Use FDA Orange Book listings for the LIBRAX dosage form and strength to obtain applicant and related listed patents. -
Can I confirm API suppliers for chlordiazepoxide HCl and clidinium bromide?
Only reliably via public regulatory documentation that names API DMF holders or via disclosures tied to the finished dosage manufacturer’s quality and regulatory submissions. -
What happens to suppliers when a pharmacy substitutes a generic for LIBRAX?
The supplier becomes the generic ANDA holder and its manufacturer/labeler network, not the brand labeler.
References (APA)
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- FDA. NDC Directory. U.S. Food and Drug Administration.
- FDA. Drug Approvals and Databases. U.S. Food and Drug Administration.
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