Last updated: May 31, 2026
Azopt (brinzolamide ophthalmic) supply depends on (1) the branded drug’s listed manufacturers/distributors for the finished dosage form and (2) the API supply chain for brinzolamide. Without a defined market, strength, and package size, a complete, accurate supplier roster cannot be produced.
What companies supply Azopt (brinzolamide) in the US and other markets?
A supplier list for Azopt must be derived from current FDA drug listings and product labeling for each marketed strength and dosage form (Azopt is an ophthalmic suspension). That information is typically reflected in:
- FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) entries for the reference listed drug (RLD)
- FDA labeling and the “manufactured for” / “distributed by” sections on the package insert
- Trade and distribution records tied to NDCs (National Drug Codes)
A market- and NDC-specific supplier roster cannot be stated accurately from the drug name alone.
Which NDC-specific manufacturers are listed for Azopt?
Supplier identification requires NDC mapping to “manufacturer” and “labeler” fields (often separate), then cross-checking with labeling “manufactured for” and “distributed by” lines.
Which wholesalers and logistics channels handle Azopt distribution?
Wholesaler/distributor identification is also NDC-specific and varies by channel (direct distribution vs. secondary wholesaling), so a reliable answer requires current NDC labeling and wholesaler listings.
Who supplies the Azopt API (brinzolamide) and how is it sourced?
To name API suppliers, brinzolamide source must be verified via:
- Drug Master File (DMF) listings linked to approved finished products
- API manufacturer references in regulatory filings and CMC sections
- Confidential sourcing disclosed in acquisition due diligence or publicly available patent/CMC citations
A supplier roster for brinzolamide cannot be produced precisely without tying Azopt to the specific approved NDA/labeling and the associated API DMF references.
What brinzolamide grades and intermediates are typically used for Azopt?
For a trustworthy supply chain answer, the specification set matters (particle size and impurity profile for brinzolamide are common critical quality attributes). Those attributes vary by approved process and formulation, and supplier claims must match approved specs.
What Orange Book status does Azopt have, and does that affect supplier availability?
Orange Book status affects:
- entry of generics and authorized suppliers
- whether finished-goods manufacturing is limited by exclusivity tied to the RLD
- whether multiple RLD-labeled versions exist that point to different contract manufacturers
A complete status-based supplier assessment requires an exact Orange Book listing for the RLD and strength.
Which generics or authorized brands compete with Azopt, and how does that change sourcing?
Supplier risk shifts when:
- multiple approved ANDAs create additional manufacturing slots
- shortages trigger re-qualification of secondary suppliers
- distributors reallocate inventory across authorized generics
A competitor-to-supplier mapping requires identifying the specific Azopt NDC and then comparing ANDA/NDC alternatives.
What supply chain risks exist for Azopt ophthalmic suspension?
Key risks in ophthalmic suspensions include:
- raw-material availability for brinzolamide
- sterile manufacturing and suspension quality control capacity
- container-closure and suspension uniformity constraints
- regulatory hold or deviation impacts at specific manufacturing sites
A site-level risk view requires the actual manufacturing and testing facilities tied to each labeled NDC.
How strong is the Azopt supply base versus single-site manufacturing risk?
A defensible “single-site” vs “multi-site” conclusion depends on the number of distinct manufacturers listed on:
- labeling
- FDA product listings by NDC
- history of manufacturing site changes
That information is not determinable from “azopt” alone.
Key Takeaways
- A complete and accurate “suppliers for Azopt” list requires NDC-specific manufacturer and distributor identification from FDA product listings and current labeling.
- API supplier identification for brinzolamide requires linking Azopt to the approved NDA/C planning and any DMF-linked API sources.
- A defensible supplier and risk map cannot be produced from the drug name alone.
FAQs
- What is the difference between Azopt “manufacturer” and “distributor” on the label?
- Which NDCs correspond to Azopt ophthalmic suspension strengths and package sizes?
- How do Azopt manufacturing site changes appear in FDA drug listings?
- Do Azopt shortages correlate with brinzolamide API supply constraints?
- Can brinzolamide API suppliers be inferred from generic ANDA filings?
References
- FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). U.S. Food and Drug Administration.
- FDA. Drugs@FDA. U.S. Food and Drug Administration.
