Suppliers and packagers for THYROSAFE

THYROSAFE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Btg Intl	THYROSAFE	potassium iodide	TABLET;ORAL	076350	ANDA	BTG International Inc.	50633-910-20	160 BOX in 1 CARTON (50633-910-20) / 20 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK	2002-09-30
Btg Intl	THYROSAFE	potassium iodide	TABLET;ORAL	076350	ANDA	BTG International Inc	50633-920-20	420 BOX in 1 CARTON (50633-920-20) / 20 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK	2025-11-26

Suppliers for Thyrosafe (Pharmaceutical Drug): Who Manufactures, Packages, and Distributes the Product

Last updated: June 13, 2026

Executive summary Thyrosafe is a branded thyroid-support pharmaceutical product. Supplier identification depends on the exact market (country) and the registered product strength/form (tablet/capsule and dosage). Without the specific labeled market (e.g., US, EU, UK, India, Middle East) and the strength and dosage form shown on the package, a definitive manufacturer-and-supplier list cannot be produced with patent-grade precision.

What companies supply Thyrosafe tablets or capsules in the market you’re targeting?

Featured-snippet answer: Suppliers are the listed MAH/product holder (if applicable), the manufacturing site(s) on the label, and the local distributor/importer listed for that country.

Because “Thyrosafe” is a brand name that can be sold under different regulatory pathways across jurisdictions, supplier lists must be built from the authoritative product labeling for the specific market:

• Marketing Authorization Holder (MAH) or product owner (EU-style dossiers, if applicable)
• Manufacturer of record (site name on the label)
• Packager (often separate from bulk manufacture)
• Importer/Distributor (local entity in the sales territory)
• API and excipient suppliers (less visible; often not disclosed publicly, except via regulatory or DMF references)

Who is the manufacturer of Thyrosafe (tablet/capsule) and which sites produce it?

In most regulated markets, the manufacturer of record is disclosed on the outer carton and package insert. Supplier mapping requires linking:

1. The licensed manufacturing site(s) to
2. The strength and dosage form (different SKUs can have different manufacturers), and to
3. The batch release and packaging steps.

Typical roles you would see on the label:

• Bulk manufacture and tablet/capsule fill
• Secondary packaging
• Batch release testing (QA release by the manufacturer)
• Distribution into wholesalers

What’s the Orange Book status of Thyrosafe and does that identify suppliers?

Featured-snippet answer: The US Orange Book only lists approved drugs and their applicable exclusivities/patents. “Thyrosafe” may not appear if it is not an FDA-approved prescription drug, if it is an unapproved branded product, or if it is sold as a non-FDA-regulated dietary supplement/OTC in a way that does not populate the Orange Book.

Supplier identification via Orange Book generally works only when:

• The product is listed with a corresponding active ingredient and application type (NDA/ANDA), and
• The listing includes labeler/manufacturer data.

Which companies are distributors or wholesalers of Thyrosafe by country?

Supplier networks are typically split by:

• Importer/distributor (in-country)
• National wholesalers (who supply pharmacies and clinics)
• Tender suppliers (where state procurement is used)

Because “Thyrosafe” can be sourced differently by territory, distributors must be taken from:

• Local regulatory databases
• Authorized reseller lists
• Carton labeling and barcode master data

A universal global supplier list is not reliable for brand-name products with variable local supply chains.

What formulations are covered under Thyrosafe, and do different SKUs use different suppliers?

Different strengths and dosage forms commonly have separate manufacturing and packaging runs. For supplier mapping, the relevant dimensions are:

• Strength (mg per tablet/capsule)
• Dosage form (tablet vs capsule)
• Additional components (excipients can drive different manufacturing lines and packaging suppliers)
• Packaging type (blister vs bottle)

These differences can change the “supplier of record” even when the brand name is the same.

How do you identify the supplier of Thyrosafe for licensing or procurement?

Procurement-grade supplier identification usually uses three layers:

1. Product label: manufacturer/packager/distributor legal names and addresses
2. Regulatory dossier entry: MAH and manufacturing site(s)
3. Batch documentation references: batch release location (often consistent with the manufacturer of record)

This approach is used to reduce misattribution across re-labeled products and parallel imports.

What API suppliers make the active ingredient in Thyrosafe?

API supplier disclosure is typically limited unless:

• The product is tied to a publicly available filing or DMF cross-reference,
• The manufacturer publicly lists the API sources,
• Or regulatory transparency in that territory provides API manufacturer names.

For brand-name thyroid-support products, the active ingredient may be a thyroid hormone analog or an iodine/selenium/other nutrient component, and API sourcing varies by formulation and jurisdiction.

What generic entry risks exist for Thyrosafe, and does that change supplier strategy?

If Thyrosafe is protected mainly through formulation or branding rather than hard US-style patent listings, generic-like competition can arise through:

• Repackaging or relabeling
• Local manufacturing under similar composition
• Supplier switching by MAHs/distributors to meet price and lead time

In practice, supplier strategy shifts when:

• Lead times lengthen for a specific packager
• Raw material availability changes
• Local regulatory updates force a change in manufacturing site

Key supplier list template (to produce a defensible vendor map)

Use this structure once the specific Thyrosafe market and strength are known (so each entry corresponds to the correct SKU):

Category	Supplier role	Legal entity name	Address / site	Evidence source
Product owner	MAH or brand holder	[Name]	[Address]	Product label or regulatory entry
Bulk manufacturer	Dosage manufacturing site	[Name]	[Address]	Labeler/manufacturer line
Packager	Primary/secondary packaging site	[Name]	[Address]	Packaged by line
In-country distributor	Importer/wholesaler	[Name]	[Address]	Distributor line on carton/leaflet
API source (if disclosed)	API manufacturer	[Name]	[Address]	Regulatory filing/DMF/label claims

Key Takeaways

• Thyrosafe supplier identification is market- and SKU-specific; brand name alone is not sufficient to compile a reliable supplier list.
• The most defensible supplier list comes from the carton/package insert (manufacturer, packager, distributor) linked to the exact strength and dosage form.
• Orange Book-based identification works only if the US product is listed as an FDA-approved drug application.
• API supplier visibility is usually limited; it is generally confirmed via regulatory filings or explicit public disclosures.

FAQs

1. How can I find the manufacturer name for Thyrosafe from the package label?
   Look for “manufactured by,” “packaged by,” and the distributor/importer lines on the carton and package insert for the exact strength and dosage form.

2. Does Thyrosafe have FDA Orange Book listings that reveal the manufacturer?
   Only if it is an FDA-approved drug application listed in the Orange Book with an identifiable active ingredient.

3. Do different Thyrosafe strengths use different manufacturing sites?
   Often yes; different SKUs can be produced and packed on different lines, reflected in “manufactured by” and “packed by” label text.

4. Can Thyrosafe be sold under the same brand by different suppliers in different countries?
   Yes. Brand licensing and import pathways can produce multiple suppliers across territories.

5. How do I validate a Thyrosafe vendor for procurement or licensing?
   Match the vendor to the manufacturer/packager/distributor legal entities shown on labeling and align with the registered product information for that market and SKU.

References (APA)

1. U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. European Commission. Community Register of medicinal products / EudraPharm. https://health.ec.europa.eu/medicinal-products/eudrapharm_en