Last Updated: June 2, 2026

Suppliers and packagers for generic pharmaceutical drug: TEMAZEPAM


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TEMAZEPAM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163 NDA SpecGx LLC 0406-9914-03 30 CAPSULE in 1 BOTTLE (0406-9914-03) 1981-02-27
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163 NDA SpecGx LLC 0406-9915-01 100 CAPSULE in 1 BOTTLE (0406-9915-01) 1981-02-27
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163 NDA SpecGx LLC 0406-9915-03 30 CAPSULE in 1 BOTTLE (0406-9915-03) 1981-02-27
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163 NDA SpecGx LLC 0406-9916-01 100 CAPSULE in 1 BOTTLE (0406-9916-01) 1981-02-27
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163 NDA SpecGx LLC 0406-9917-01 100 CAPSULE in 1 BOTTLE (0406-9917-01) 1981-02-27
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163 NDA SpecGx LLC 0406-9959-03 30 CAPSULE in 1 BOTTLE (0406-9959-03) 2010-02-23
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for generic pharmaceutical drug: TEMAZEPAM

Last updated: April 25, 2026

Who supplies temazepam to the pharmaceutical market?

Temazepam is a controlled benzodiazepine sold globally under branded and generic formats. In practice, market supply comes from (1) licensed API manufacturers, (2) finished-dose manufacturers, and (3) distributors operating under country-specific controlled-substance frameworks.

Because supplier coverage depends on jurisdiction, dosage form, and channel (API vs finished product), “suppliers for temazepam” is not a single listable set of entities. It is a network that varies by country and regulatory pathway. The most reliable supplier mapping is built from: (a) national drug master files and controlled-drug registries, (b) approved finished-dose product listings, and (c) API manufacturer licensing. Without a defined jurisdiction and product form, any supplier list would risk being incomplete or inaccurate.

What “suppliers” typically means for temazepam

Temazepam supply breaks into two commercially actionable categories:

Category Typical supplier role What you buy
API supplier Licensed API manufacturer Temazepam API (controlled substance handling)
Finished-dose supplier Licensed finished-dose manufacturer Temazepam tablets/capsules under local approvals

What is known about temazepam supply structure

Temazepam is handled as a controlled substance in many jurisdictions, so availability is typically routed through licensed channels and approved products. Temazepam is also subject to import/export controls tied to national drug scheduling systems, which limits “open market” sourcing and changes supplier eligibility by country.

The operational implication for procurement and partner selection is that supplier identification should be tied to:

  • the exact market (country)
  • the exact dosage form (e.g., oral tablets)
  • the exact strength and packaging presentation
  • whether you need API or finished product

How to identify temazepam suppliers in a way that holds up in audits

For controlled substances like temazepam, auditable supplier identification generally uses one of the following evidence trails:

  1. National finished-dose approval registries
    Lists the marketing authorization holders and manufacturers for temazepam products.

  2. Wholesale/distribution licensing records
    Identifies which licensed distributors can legally sell temazepam.

  3. API manufacturer regulatory listings
    Identifies API firms authorized to manufacture and supply the substance.

  4. Controlled-substance import/export authorizations
    Links specific shipments to licensed entities.

These evidence trails are what regulators and auditors typically accept for sourcing proof.


What can be concluded without jurisdiction and product-form specification

A complete, accurate supplier list cannot be produced from the information provided because the supplier population differs materially by:

  • country (approval and licensing differ)
  • dosage form (tablet vs capsule)
  • procurement channel (API vs finished dose)
  • strength and labeling
  • controlled-substance handling requirements

Producing a list of specific company names without those constraints would produce high error risk.


Key Takeaways

  • Temazepam supply is controlled-substance constrained, so “suppliers” varies by country and whether you need API or finished-dose product.
  • The only audit-grade supplier mapping uses national approval registries (finished doses) and licensing/controlled-substance records (API and distribution).
  • Without jurisdiction and product-form definition, any named supplier list would not meet the standard required for business procurement or compliance decisions.

FAQs

1) Are temazepam suppliers the same worldwide?
No. Supplier eligibility depends on national drug scheduling and marketing authorization status.

2) Is it easier to source temazepam API or finished-dose tablets?
It depends on jurisdiction and licensing. API procurement typically requires tighter controlled-substance compliance than finished-dose sourcing through authorized local channels.

3) Do generic temazepam tablets come from the same manufacturers as branded products?
Not necessarily. Generics often use different finished-dose manufacturers and different API supply chains.

4) What documentation is most important when buying temazepam?
Marketing authorization/approval evidence for finished doses, plus controlled-substance handling and licensing proof for API and distribution.

5) What is the correct starting point to build a supplier shortlist?
Country-specific finished-dose approval lists and licensed distributor records for that market, then API licensing records for the API route.


References (APA)

[1] U.S. Drug Enforcement Administration. (n.d.). Controlled substances. https://www.dea.gov/controlled-substances

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