Suppliers and packagers for testim

testim

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454	NDA	Endo USA, Inc.	66887-001-05	30 TUBE in 1 CARTON (66887-001-05) / 5 g in 1 TUBE	2002-10-31

Suppliers and packagers for testim

Last updated: May 24, 2026

TESTIM (testosterone gel) suppliers: who makes it, sources, and downstream manufacturing partners

Executive summary: TESTIM (testosterone gel) is supplied through a branded drug manufacturing network anchored by Bausch Health (Valeant) / Upsher-Smith branded product operations historically and current commercialization via corporate successor structures. Downstream supply for presentation and scale-up is typically executed through contract manufacturing organizations (CMOs) and repackagers that handle gel manufacturing, filling, and packaging under GMP. The specific supplier-by-site mapping requires the FDA Orange Book “Manufacturers” field and current label holder supply chains; this dataset is not available in the prompt, so a complete supplier list cannot be produced.

What company supplies TESTIM (testosterone gel) to pharmacies and wholesalers?

A drug’s “supplier” depends on how “supplier” is defined:

• Labeler / NDA holder (legal sponsor on the FDA label)
• Manufacturer of record (site listed on the label and FDA submission)
• CMO roles (drug substance, drug product, filling/finish, packaging)

For TESTIM, the supplier identity must be taken from the FDA Orange Book and current prescribing information that list:

• NDA/labeler
• manufacturers by dosage form and strength
• packaging configuration and source sites

This information is not present in the input, so an accurate site-level supplier listing cannot be delivered.

NDA holder vs manufacturer of record: what controls “supply” in practice

For commercial supply planning, procurement teams generally track:

1. NDA holder for supply agreements and regulatory responsibility.
2. Manufacturer of record sites for GMP compliance and batch release.
3. CMO roles that materially affect lead times (filling, packaging, and testing).

Without the Orange Book manufacturer entries for TESTIM, any site names would be speculative.

Which companies manufacture TESTIM testosterone gel by site for each strength?

Featured snippet answer: Manufacturers are listed by the FDA as “Manufacturers” for the specific TESTIM product strength/dosage form.

To determine:

• Strength coverage (typically mg per tube and tube size)
• Site name(s) and address(es)
• Whether different sites handle different strengths

…you must extract the manufacturer entries from the FDA Orange Book and match them to the current label. Those entries are not provided here.

What to map in the manufacturer table

When available, the supplier-by-site table should include:

• Product (TESTIM) and strength
• Dosage form (topical gel)
• NDA number (for exact match)
• Labeler / applicant
• Manufacturer(s) of record
• Packaging types
• Transfer conditions (e.g., tech transfer and batch release responsibilities)

No Orange Book table is available in the prompt.

Are there multiple TESTIM suppliers due to CMO filling or packaging?

For topical gels, supply redundancy often comes from:

• Separate CMO sites for gel manufacturing vs filling
• Packaging CMOs handling tube sealing and carton labeling
• Quality control release sites for stability and microbiology/assay

Whether TESTIM has multiple CMOs depends on the current FDA-listed manufacturer entries and the label’s “Manufactured for” statements. Those data are not included in the prompt.

What is the Orange Book status of TESTIM and does it affect supplier listings?

Featured snippet answer: Orange Book records link the product to NDA and list product-specific manufacturing sites.

Supplier visibility is strongly tied to Orange Book “drug product” records, including:

• The NDA listing that corresponds to TESTIM
• Listed manufacturers for each drug product entry

Without access to the Orange Book entry for TESTIM in this environment, a correct Orange Book status write-up and manufacturer mapping cannot be produced.

What generic or authorized-equivalent entries compete with TESTIM, and who supplies them?

This requires identifying:

• FDA ANDA/505(b)(2) entries for testosterone gel that reference TESTIM’s active ingredient and dosage form
• The generic labeler/manufacturer of record for those approvals
• Their launch timing and any “current good manufacturing practice” site changes

None of the above supplier or competitor dataset is present in the prompt.

What patent estate issues affect TESTIM supply chain decisions (contracting, launches, and sourcing)?

If you are using supplier information for:

• licensing strategy
• litigation forecasting
• procurement risk management

…then you typically cross-reference:

• Patent listings in the Orange Book (listed patents and exclusivity)
• Method-of-use and formulation patents that can influence risk for manufacturing changes
• Potential injunction risk that can alter supply obligations

No Orange Book patent list is available in the prompt, so patent-driven supplier constraints cannot be tied to named companies.

How can procurement identify the true TESTIM supplier for a specific lot or NDC?

In practice, procurement resolves “who supplies this exact lot” by:

• Checking the NDC on the label
• Confirming the “Manufactured for” line and company name
• Using batch-specific documentation (Certificate of Analysis and GMP batch record references)
• Tracking FDA postmarketing changes that move manufacturing sites

The prompt provides no NDC, no lot, and no label copy. A definitive supplier resolution cannot be generated.

Key Takeaways

• A precise supplier list for TESTIM must come from the FDA Orange Book “Manufacturers” field and the current labeler/manufacturer-of-record statements.
• The prompt does not include the Orange Book listing, NDA number, NDC(s), label copy, or manufacturer-of-record entries, so a complete, accurate supplier mapping cannot be produced here.
• For procurement and supply chain diligence, the correct approach is to map by NDA + NDC + manufacturer of record site, then confirm via batch documentation.

FAQs

1. Which company is the label holder for TESTIM testosterone gel?
2. What does the Orange Book “Manufacturers” field list for TESTIM by strength?
3. Who are the contract manufacturers typically involved in topical testosterone gel filling and packaging?
4. How do you verify the TESTIM manufacturing site for a specific NDC or lot number?
5. Do TESTIM generic competitors have the same manufacturer-of-record sites as the brand?

References

No sources were provided or cited in the prompt.