Last updated: May 29, 2026
Micronized glyburide supply is dominated by bulk API producers and high-potency oral dosage manufacturers that can meet particle-size and blend-uniformity controls for immediate-release tablets using micronized active.
What companies supply micronized glyburide API for tablet manufacturing?
Answer: Micronized glyburide is supplied through (1) API producers that offer glyburide with controlled particle-size specifications, and (2) contract manufacturers that micronize and certify the active to particle-size and purity specs prior to blending into tablets. Supplier lists for “micronized” are typically documented as specification offerings rather than as a distinct regulatory-grade monograph category.
Common supplier models for micronized glyburide
- API manufacturer with particle-size option
- Provides glyburide API with defined D90 (or similar) particle-size targets in the certificate of analysis.
- API micronization and certification at the contract manufacturing site
- Source API is micronized in-house or under contract and tested for particle size distribution and content uniformity.
- Finished dosage manufacturers (FDF) that buy micronized API
- Use supplier-controlled particle-size grades to meet dissolution and uniformity requirements.
How to map “micronized” suppliers in practice
- Look for suppliers that publish or support particle-size controlled glyburide in COAs/specifications.
- Confirm the grade used matches the drug product’s dissolution target, not only bulk assay and impurity profile.
Which suppliers provide micronized glyburide tablets (finished dosage) for the US market?
Answer: Finished-dose supply is typically handled by generic manufacturers licensed to market glyburide tablets; some vendors source micronized API from upstream API suppliers and micronize or blend under GMP. Finished products are listed on FDA’s Orange Book under glyburide tablet strengths, with different NDA/ANDA owners and labelers depending on the applicant.
Where finished-dose supplier identification is anchored
- FDA Orange Book for the glyburide immediate-release tablet label (active ingredient: glyburide).
- ANDA applicant/labeler identifies the commercial manufacturer/distributor chain.
- The submission (CMC) package typically references the API source and micronization/particle-size control strategy.
How many API and micronization-capable suppliers cover glyburide globally?
Answer: Coverage is typically “medium,” with a limited number of API producers and fewer that support micronized particle-size specifications consistently. The effective supplier pool narrows further because glyburide is an older, low-to-moderate demand molecule where particle-size control and regulatory documentation can be the differentiator.
Supplier pool segmentation
- API supply: fewer specialized producers able to meet impurity and polymorph requirements.
- Micronization services: even fewer can handle high-potency blending impacts and validate particle-size targets reproducibly.
- Tablet manufacturing: multiple firms can tabletize, but not all can guarantee the micronized active’s performance batch-to-batch.
What criteria determine whether a supplier can deliver micronized glyburide at launch scale?
Answer: Particle-size distribution control, impurity profile, and batch release testing capacity are the gatekeepers.
Technical and quality controls buyers typically require
- Particle-size distribution (D10/D50/D90 or equivalent)
- Polymorph confirmation (where applicable)
- Residual solvents and elemental impurities
- Content uniformity support for low-dose strengths
- Blend uniformity validation in the final dosage
- GMP documentation for micronization steps (if performed)
What manufacturing and IP barriers affect glyburide micronized supply?
Answer: For glyburide (micronized) as a drug substance, IP barriers are usually less about “micronization patent rights” and more about the regulatory and process knowledge embedded in ANDA manufacturing. Contract manufacturing availability and validation burden can limit how fast new qualified suppliers enter.
Where process barriers show up
- Validated micronization process parameters
- Milling equipment cleaning and cross-contamination controls
- Dissolution bridging and robustness evidence
What is the Orange Book status of micronized glyburide tablets?
Answer: Glyburide tablets are widely marketed as generics; Orange Book entry status varies by strength and dosage form (immediate release tablets). The Orange Book is the authoritative source for patent/exclusivity-linked listings, but it does not explicitly list “micronized” as a separate regulatory class.
Practical implication
- Micronized status is a CMC specification. Orange Book confirms drug product approvals, not always the active’s particle-size descriptor.
How do suppliers differ between micronized glyburide API and alternative particle-size grades?
Answer: Suppliers that provide multiple particle-size grades can reduce buyer risk during scale-up by allowing process parameter adjustments rather than requiring a single fixed spec.
Grade-dependent performance risks
- Dissolution rate variation
- Blend uniformity variation
- Downstream tablet hardness friability differences
Key Takeaways
- Micronized glyburide supply is typically delivered through API producers offering controlled particle-size glyburide or through GMP micronization at contract manufacturing sites.
- Finished-dose “supplier” mapping is best done through the FDA Orange Book ANDA applicant/labeler, then tracing upstream CMC references for the particle-size control strategy.
- Supplier qualification hinges on particle-size distribution, impurity profile, and validated blending/dissolution performance rather than on a standalone “micronized” designation.
FAQs
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How do I confirm a glyburide supplier really supplies micronized API and not just “fine” bulk?
Require a COA with particle-size distribution and milling validation documentation, plus batch release data tied to dissolution or blend uniformity controls.
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Do micronized glyburide suppliers list D90 particle-size targets openly?
Often they provide targets in QMS/specifications and confirm in COAs; public marketing language may be generic.
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Can a tablet manufacturer qualify non-micronized glyburide and still meet dissolution by process adjustment?
Sometimes, but it requires formulation and process validation, including dissolution bridging and content uniformity demonstration.
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What is the most common buyer risk when switching micronized glyburide suppliers?
Particle-size distribution drift that impacts dissolution and tablet content uniformity.
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Does Orange Book indicate the particle-size form of glyburide?
Orange Book listings confirm approvals and patent/exclusivity status; particle-size descriptors like “micronized” are usually CMC-level details, not consistently listed as a separate regulatory category.
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026). https://www.accessdata.fda.gov/scripts/cder/daf/
