Suppliers and packagers for BETOPTIC S

BETOPTIC S

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	BETOPTIC S	betaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	019845	NDA	Novartis Pharmaceuticals Corporation	0078-0729-10	1 BOTTLE in 1 CARTON (0078-0729-10) / 10 mL in 1 BOTTLE	1996-01-15
Novartis	BETOPTIC S	betaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	019845	NDA	Novartis Pharmaceuticals Corporation	0078-0729-15	1 BOTTLE in 1 CARTON (0078-0729-15) / 15 mL in 1 BOTTLE	1996-01-15

Suppliers and packagers for BETOPTIC S

Last updated: April 25, 2026

Who Supplies BETOPTIC S (betaxolol ophthalmic) and How to Identify the Manufacturing Chain

BETOPTIC S is a brand-name betaxolol hydrochloride ophthalmic solution. The supplier landscape is anchored to the market authorization holder/brand owner and the contract manufacturers that produce the drug product (and, in most cases, the API supply chain). The operational way to identify “suppliers” for BETOPTIC S is to pull the labels and regulatory submissions for the specific marketed presentation (strength, dosage form, and country).

What “supplier” means for BETOPTIC S in practice

For downstream sourcing and diligence, “supplier” for a branded ophthalmic product typically resolves into four concrete categories:

1. Marketing authorization holder / brand owner (responsible party on the label and in regulatory filings).
2. Finished dosage form manufacturer (holds drug product manufacturing authorization and appears as “Manufactured for/Distributed by” on packaging).
3. API supplier(s) (betaxolol hydrochloride; usually disclosed in regulatory dossiers rather than consumer packaging).
4. Contract packer / distributor (may appear on the label even when the drug product is made elsewhere).

BETOPTIC S: what you can verify on the product label

The label is the highest-integrity and fastest route to define the supplier set for a specific market because it identifies at least two roles (brand/distributor and product manufacturer). The key lines to extract from the outer carton and package insert are:

• “Manufactured for [Company]”
• “Manufactured by [Company]”
• “Distributed by [Company]”
• “Storage” and “NDC” (for US) to map the specific listed manufacturer to the correct filing

Without the exact country and strength/presentation, supplier identification can only be stated at the structural level, not the named entity level.

Supply chain structure for betaxolol ophthalmic products

Betaxolol ophthalmic brands follow a standard value chain:

• API: betaxolol hydrochloride produced under GMP by chemical manufacturers (API suppliers usually do not appear on consumer labels).
• Drug product: ophthalmic solution is formulated and filled by sterile production sites using validated aseptic processing.
• Packaging: sterile ophthalmics are packaged and labeled by the drug product site or via a contract packer.

In diligence terms, the “supplier” list you need for BETOPTIC S consists of the drug product manufacturer(s) and the brand/distribution entity tied to the specific NDC or national trade item.

Market-access identifiers that link you to the correct supplier

To identify the correct manufacturer for BETOPTIC S, you use the market identifier that ties to the regulatory listing:

Market identifier	Where it appears	Why it matters for suppliers
NDC (US)	Label/carton	Directly maps to a specific manufacturer and labeler on the FDA drug listing
PL number (EU/UK varies)	SmPC/label	Maps to the marketing authorization and manufacturer details in the regulatory product profile
National registration number	Local product dossier	Maps to the approved manufacturing sites and responsible legal entity
Presentation (strength, container type)	Carton and leaflet	Prevents cross-matching suppliers across different strengths or bottle sizes

Actionable supplier identification workflow (what your team should extract)

Use these extraction points to build the supplier register:

1. Capture the NDC (or local registration) and strength from the specific BETOPTIC S carton you are sourcing against.
2. Record “Manufactured for” and “Manufactured by” entries verbatim from the label.
3. Cross-check the manufacturer name against the regulatory database listing tied to that identifier.
4. Build two supplier tiers:
   • Tier 1: label-identified drug product manufacturer and labeler/distributor
   • Tier 2: API manufacturer only from regulatory dossiers/DMFs (not from consumer packaging)

Named suppliers

No named supplier entities can be provided from the information in the prompt alone. Supplier names for BETOPTIC S vary by country, strength, and packaging presentation, and those names are printed on the product label and registered to specific listings. Without those exact identifiers, supplying a definitive list of manufacturers and distributors would be incomplete or potentially incorrect.

Key Takeaways

• “Suppliers for BETOPTIC S” must be defined by market and presentation, because the label-identified manufacturer and distributor can differ across listings.
• The fastest accurate supplier identification is via the label plus the market identifier (NDC in the US or the national registration number elsewhere).
• Your supplier register should be built as Tier 1 (drug product manufacturer + distributor/labeler) and Tier 2 (API supplier from regulatory dossiers).

FAQs

1. What supplier names should be captured first for BETOPTIC S?
   The label entries for “Manufactured for”/“Manufactured by” and the distributor/labeler on the specific presentation.

2. Is the API supplier visible on BETOPTIC S packaging?
   Typically not. API suppliers are usually disclosed in regulatory filings rather than consumer labels.

3. Why does BETOPTIC S have different suppliers across markets?
   Different markets can use different labelers and manufacturing sites under the same brand.

4. What single identifier best ties the product to its manufacturer?
   In the US, the NDC tied to the specific strength and dosage form.

5. Does the supplier set change with bottle size or strength?
   Yes. Different presentations can map to different packaging and sometimes different manufacturing sites, so suppliers must match the exact presentation.

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References

[1] FDA. “NDC Directory.” FDA National Drug Code (NDC) Directory. https://www.accessdata.fda.gov/scripts/cder/ndc/
[2] FDA. “Drugs@FDA.” FDA. https://www.accessdata.fda.gov/scripts/cder/daf/