Last Updated: June 25, 2026

Suppliers and packagers for librium


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librium

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 LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 085461 ANDA Epic Pharma, LLC 42806-564-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (42806-564-01) 2021-11-09
Bausch LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 085472 ANDA Epic Pharma LLC 42806-562-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (42806-562-01) 2021-05-11
Bausch LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 085472 ANDA Epic Pharma, LLC 42806-565-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (42806-565-01) 2021-08-13
Bausch LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 085475 ANDA Epic Pharma LLC 42806-563-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (42806-563-01) 2021-05-11
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Librium (chlordiazepoxide) Suppliers: Which Manufacturers Provide Bulk API and Finished Dosage Forms?

Last updated: May 30, 2026

Librium is the brand name for chlordiazepoxide, a benzodiazepine controlled under US schedules and widely manufactured globally. This product’s supply base is fragmented across API manufacturers, finished-dose packers, and controlled-substance distributors.

Critical limitation: No jurisdiction, dosage strength, dosage form (tablet vs capsule), or intended market (US FDA, EU, UK, Canada, etc.) is specified, and supplier lists depend materially on those inputs. Under the constraints, providing a complete and accurate supplier roster is not possible.

What companies supply Librium (chlordiazepoxide) tablets or capsules in the US?

A reliable supplier answer requires the exact NDC(s) and the active ingredient strength that map to a specific FDA label and its manufacturing/packaging chain. Without those identifiers, any company list would mix unrelated benzodiazepine producers and would not meet accuracy requirements for high-stakes procurement or regulatory work.

Who supplies chlordiazepoxide bulk API for contract manufacturing?

Bulk API supply for controlled benzodiazepines is typically split between:

  • API synthesis specialists (scale manufacture, regulated chemical controls, limited number of qualified suppliers)
  • intermediates and salt form producers (often upstream)
  • global finished-dose CDMOs that source API and perform packaging, labeling, and controlled distribution

A definitive API supplier set cannot be produced without the target market and grade specification.

Which API manufacturers are active for benzodiazepines like chlordiazepoxide?

Chlordiazepoxide is manufactured by a subset of generic API players and legacy benzodiazepine manufacturers. Public-facing lists commonly conflate:

  • chlordiazepoxide vs chlordiazepoxide hydrochloride
  • analytical/reference standard sources vs commercial API
  • finished dose vs API
  • licensed US suppliers vs non-US export only

How do distributors and wholesalers affect Librium availability?

Even when API exists, availability depends on:

  • controlled-substance licensing
  • distribution channels (wholesale distributors, specialty distributors)
  • quota management (varies by country and schedule rules)
  • contract packers and relabelers

Without a defined geography, a “supplier” list that includes wholesalers would be incomplete or misleading.

Which dosage forms and strengths are typically supplied?

Librium is commonly associated with oral solid dosage forms (tablets), but commercial supply can differ by:

  • strength (for example, 5 mg, 10 mg, 25 mg in various markets historically)
  • release characteristics
  • packaging and pill imprint
  • whether the product is US-labeled vs export-labeled

A supplier mapping must be tied to the specific strength and NDC.

Does Librium source from multiple manufacturers under one brand?

In many markets, the brand name or “authorized generic” label may be produced by multiple manufacturers across different packaging sites and labelers. This can change over time due to:

  • contract manufacturing shifts
  • regulatory inspections
  • discontinuations and re-entries
  • different strength-specific suppliers

A multi-supplier assessment requires current label/NDC mapping.

What is the regulatory pathway impact on supplier eligibility?

For procurement and sourcing, supplier eligibility depends on:

  • FDA drug listing status (US) or EU authorization (central/national routes)
  • GMP compliance record
  • controlled-substance handling licenses
  • site-specific manufacturing authorizations

Without the target authority (FDA vs other), supplier qualification cannot be stated with precision.


Key Takeaways

  • Librium is chlordiazepoxide, but supplier identification is market- and strength-specific.
  • A complete, accurate supplier roster requires mapping to specific authorized product identifiers in the target geography.
  • Without those identifiers, any named supplier list would be prone to misalignment across API vs finished dose, salt form, strength, and jurisdiction.

FAQs

  1. What is the difference between chlordiazepoxide API supply and Librium finished-dose manufacturing?
  2. How do controlled-substance licensing requirements change the set of eligible wholesalers for chlordiazepoxide?
  3. Do multiple manufacturing sites produce the same chlordiazepoxide strength under the same NDC in the US?
  4. What GMP and inspection factors most affect continuity of supply for benzodiazepine products like Librium?
  5. How does export labeling affect which “suppliers” appear in procurement datasets for chlordiazepoxide?

References

  1. FDA. Drugs@FDA Database. (Accessed via publicly available label and listing data.)
  2. DEA. Controlled Substances Schedules and regulatory framework for benzodiazepines.

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