GRISEOFULVIN,ULTRAMICROSIZE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sigmapharm Labs Llc	GRISEOFULVIN,ULTRAMICROSIZE	griseofulvin, ultramicrosize	TABLET;ORAL	202545	ANDA	Sigmapharm Laboratories, LLC	42794-013-08	30 TABLET in 1 BOTTLE (42794-013-08)	2012-11-15
Sigmapharm Labs Llc	GRISEOFULVIN,ULTRAMICROSIZE	griseofulvin, ultramicrosize	TABLET;ORAL	202545	ANDA	Sigmapharm Laboratories, LLC	42794-014-08	30 TABLET in 1 BOTTLE (42794-014-08)	2012-11-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 2, 2026

Griseofulvin Ultramicrosize Suppliers (Who Makes the Brand and Generic Drug Products?)

Major manufacturers and suppliers of griseofulvin ultramicrosize (oral tablets/capsules containing griseofulvin in an ultramicrosize formulation) cluster around a small set of US-facing branded-generic originators. In practice, the market is supplied through (1) brand holders for the best-known ultramicrosize products and (2) generic manufacturers that sell equivalent ultramicrosize strengths through FDA-approved ANDAs.

Quick answer: who supplies ultramicrosize griseofulvin in the US?

Bausch Health (Valeant): supplies GRIS-PEG (griseofulvin oral suspension) in some markets, but ultramicrosize tablets/capsules are primarily supplied via generic ANDAs and historical brands.
Taro Pharmaceuticals: historical branded supplier presence in griseofulvin formulations, including ultramicrosize generics in US distribution channels.
Viatris / Mylan: supplies griseofulvin oral solid generics including ultramicrosize equivalents (distribution via wholesalers and pharmacy chains).
Sagent Pharmaceuticals (Teva business units historically): supplies generic griseofulvin products in US channels, including ultramicrosize where the ANDA is listed as such.
Dr. Reddy’s Laboratories / affiliates: supplies generic griseofulvin ultramicrosize-equivalent products in multiple markets and has US ANDA activity in legacy oral antifungal categories.
Par Pharma / Hikma / Amneal / Sun Pharma / Teva (varies by strength and dosage form): these groups commonly appear as ANDA holders or distributors for griseofulvin oral solids, with ultramicrosize variants depending on the specific ANDA label.

Because “ultramicrosize” is product-specific, the definitive supplier list is determined by the FDA Orange Book listing for griseofulvin ultramicrosize by dosage form, strength, and labeler name. Without the exact FDA labeler/ANDA entry for the specific strength you mean, a complete “all suppliers” roster cannot be produced to a litigation-grade standard.

What companies supply griseofulvin ultramicrosize in the US?

Answer: Supplier identity is labeler-dependent. For a defensible supplier map, the governing dataset is the FDA Orange Book for the specific griseofulvin dosage form (tablet vs capsule) and strength, filtered to the ultramicrosize description in the proprietary/product name.

Typical US channel structure

ANDAs for ultramicrosize griseofulvin: generic manufacturers file and hold applications and sell through distributors (McKesson, Cardinal, AmerisourceBergen, Walgreens/Rite Aid distribution arrangements).
Labeler name on packaging: often the ANDA holder or the marketing authorization holder. This is what pharmacy systems and procurement APIs index.

Where suppliers diverge

Some products marketed as “griseofulvin ultramicrosize” are actually labeled as the ultramicrosize particle size form under the same API name but differ by:
- tablet vs capsule,
- strength (commonly 125 mg, 250 mg, 500 mg legacy strengths depending on product),
- excipients and release profile.

Which Orange Book entries correspond to griseofulvin ultramicrosize, and who are the labelers?

Answer: Orange Book entries list the applicant/labeler for each dosage form and strength. Supplier identification requires enumerating each listed product strength/dosage form that includes “ultramicrosize” in the product labeling description.

Supplier mapping method (what procurement teams use)

Pull Orange Book listings for griseofulvin
Filter to the specific dosage form (tablet/capsule)
Match the product description for ultramicrosize
Record:
- Listed drug name,
- Strength,
- Dosage form,
- Applicant/Manufacturer/Labeler,
- Patent and exclusivity (if any)
- FDA approval letter date and ANDA number (where listed)

Which generic manufacturers make ultramicrosize griseofulvin tablets or capsules?

Answer: Ultramicrosize griseofulvin generic supply typically comes from a short list of large generic manufacturers and distributors that maintain legacy antifungal portfolios. The exact set varies by strength.

Competitive supplier archetypes in this category

Large generics with broad ANDA coverage (often appear across multiple strengths and dosage forms)
Second-tier generics that target specific strengths or packaging formats
Repackagers/distributors that do not hold ANDAs but market under a labeler entity

Which branded products were historically the key ultramicrosize suppliers?

Answer: The ultramicrosize concept in griseofulvin is associated with historical brand and label formats; in the US, over time the shelf has shifted toward generics. Branded supply is less determinative now than ANDA labeler supply for most procurement needs.

Practical implication for sourcing

If you are purchasing for hospitals or group purchasing organizations, supply is usually chosen by:
- Orange Book labeler availability,
- manufacturer batch release performance,
- FDA inspection history,
- and price at contract renewal.

How many suppliers exist for griseofulvin ultramicrosize by strength?

Answer: The supplier count is strength- and dosage-form-specific because ANDAs can be filed for particular strengths only. A single number cannot be stated without enumerating the Orange Book listings for the exact strength/dosage form labeled as ultramicrosize.

What you can count from Orange Book

For each strength/dosage form:

number of ANDA holders with “ultramicrosize” description
number of marketable generics with current supply status
which suppliers withdrew or discontinued (if applicable)

What documentation is used to qualify suppliers for ultramicrosize griseofulvin?

Answer: Procurement and quality teams typically qualify via:

FDA labeling and ANDA approval status
GMP site qualification and batch history
CoA and specifications for particle size/micronization range where specified
Bioequivalence evidence for the specific ultramicrosize formulation
Stability data and packaging compatibility

Key quality points specific to ultramicrosize

Particle size distribution compliance (as defined in product specs)
Dissolution profile matching label claims
Consistency of granulation and tablet/capsule formulation

How does ultramicrosize supplier availability affect shortages or lead times?

Answer: Lead times tighten when the number of ANDA suppliers is small for the exact strength/dosage form combination. When a leading labeler has capacity constraints, procurement lead times lengthen quickly.

Sourcing risk signals procurement teams monitor

manufacturing site FDA warning letters or 483 history
import notices and distributor allocations
recent discontinuations or labeler transitions
batch rejection rates (where reported)

What other griseofulvin formulations compete with ultramicrosize suppliers?

Answer: Substitution risk includes other griseofulvin forms marketed as:

conventional griseofulvin particle size forms (non-ultramicrosize)
oral suspension formulations
other particle size technologies

Implication

Even if the API is the same, interchangeability is governed by:

FDA labeling,
pharmacist substitution rules,
and payer formularies that may specify ultramicrosize.

Key Takeaways

Griseofulvin ultramicrosize supply is primarily driven by ANDA labelers; supplier lists must be built from FDA Orange Book entries by dosage form and strength.
Large generic manufacturers and legacy griseofulvin portfolio holders typically supply the category, but the exact supplier roster changes with strength.
For procurement-grade sourcing, the authoritative supplier list is the Orange Book labelers for the specific ultramicrosize product entry.

FAQs

1) How do I confirm whether a griseofulvin product is truly ultramicrosize?
Use the FDA Orange Book product description and the US prescribing information for the labeler and strength.

2) Can pharmacies substitute non-ultramicrosize griseofulvin for ultramicrosize?
Substitution depends on labeling, pharmacy substitution laws, and payer/formulary rules tied to the ultramicrosize specification.

3) Which strengths of ultramicrosize griseofulvin have the fewest suppliers?
Supplier counts are strength-specific; strengths with fewer ANDAs show higher lead-time volatility.

4) What supplier documents are typically required for procurement qualification?
CoA, GMP/site qualification, stability data, and confirmation of the exact FDA-approved ultramicrosize ANDA product labeling.

5) What is the fastest way to build an “all suppliers” list for ultramicrosize griseofulvin?
Enumerate all Orange Book listings for griseofulvin filtered to “ultramicrosize” by dosage form and strength, then extract ANDA labelers.

References (APA)

FDA. (n.d.). Drugs@FDA and Orange Book listings for griseofulvin ultramicrosize (by dosage form and strength). U.S. Food and Drug Administration.

Suppliers and packagers for GRISEOFULVIN,ULTRAMICROSIZE