Suppliers and packagers for generic pharmaceutical drug: PYRIDOSTIGMINE BROMIDE

PYRIDOSTIGMINE BROMIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	REGONOL	pyridostigmine bromide	INJECTABLE;INJECTION	017398	NDA	Sandoz Inc	0781-3040-95	10 AMPULE in 1 CARTON (0781-3040-95) / 2 mL in 1 AMPULE (0781-3040-72)	2005-05-10
Bausch	MESTINON	pyridostigmine bromide	SYRUP;ORAL	015193	NDA	Bausch Health US, LLC	0187-3012-20	473 mL in 1 BOTTLE (0187-3012-20)	1965-01-25
Bausch	MESTINON	pyridostigmine bromide	SYRUP;ORAL	015193	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-307-05	473 mL in 1 BOTTLE (68682-307-05)	2019-07-01

PYRIDOSTIGMINE BROMIDE: Which Companies Supply It for Pharmaceutical Use?

Last updated: April 24, 2026

Who manufactures or supplies pyridostigmine bromide?

Pyridostigmine bromide is supplied by multiple global chemical and pharmaceutical ingredient manufacturers. The market commonly sees supply through branded API manufacturers and bulk chemical producers, with distribution handled by ingredient trading and specialty pharma suppliers. The supplier base below focuses on companies that appear as API producers and/or market-facing suppliers for pyridostigmine bromide in widely used public product catalogs and regulatory-facing listings.

Manufacturers / API suppliers (global)

Supplier	What they supply (typical)	Evidence type
Mylan Pharmaceuticals / Viatris group entities	Pyridostigmine bromide drug product supply presence in regulated markets	U.S. label references of company involvement in marketed product supply chain (as reflected in prescribing information)
Bausch Health (and/or legacy Valeant entities)	Market presence for pyridostigmine bromide (distribution through marketed product channels)	U.S. product label references to marketed product supply
Catalent (site-dependent; contract manufacturing through drug products, not necessarily API)	Finished-dose supply in some territories depending on product ownership	U.S. label and manufacturer-of-record references

Note: Pyridostigmine bromide is also widely sold as a bulk chemical/API in multiple grades (USP/EP, analytical grade). Those suppliers typically market it through chemical catalogs and ingredient distributors, which changes by region.

Which supplier types dominate pyridostigmine bromide availability?

Supplier type	Typical role	Why it matters for sourcing
API manufacturers	Produce pyridostigmine bromide bulk active ingredient	Determines API specifications, impurity profile, and batch consistency
Drug product manufacturers	Produce tablets/liquid drug products that contain pyridostigmine bromide	Determines formulation route, tablet/pack sizes, and documentation package
Chemical distributors / ingredient traders	Resell bulk chemical/API from multiple upstream makers	Determines lead times, documentation, and regional availability

What documentation is standard when sourcing pyridostigmine bromide?

Suppliers that sell to pharmaceutical customers typically provide a documentation bundle that supports quality and regulatory expectations:

• COA (Certificate of Analysis) for each lot
• Specification sheet (assay, identification, impurities)
• Analytical method description (or reference to pharmacopeial methods)
• Quality documents such as GMP status statements (for pharmaceutical-grade)
• Stability and storage conditions (where applicable to the grade sold)

What grades are typically supplied?

Grade category	Typical use	Common requirements
Pharmaceutical / USP-grade	Generic drug manufacture and development	Meets pharmacopeial specs (assay/ID/impurities)
Chemical / industrial grade	Research and non-GMP manufacturing uses	Lower burden documentation than GMP-grade
Analytical reagent	Testing and method development	Purity suited for analytical workflows

Which prescribing and drug-label sources can be used to map marketed supply?

Market mapping for finished-dose pyridostigmine bromide relies on U.S. prescribing information identifiers that name the “manufacturer” and/or “labeler.” These documents help connect drug product supply entities to the pyridostigmine bromide market, even when upstream API sourcing differs.

U.S. label mapping basis

Label field	What it indicates	Practical use
“Manufactured for” / “Distributed by”	Market-facing entity supplying the branded/generic product	Helps identify drug product supply chain parties
NDC-linked labeler / manufacturer of record	Formal record for the product you buy	Used for procurement and compliance records

What are the main sourcing risks to account for in supplier selection?

Risk	How it shows up	Sourcing mitigation
API impurity drift across lots	Out-of-spec impurities or assay variation	Lock specifications and impurity reporting requirements
Grade mismatch	Wrong documentation for the intended GMP use	Source only the correct grade and request GMP-grade COAs
Lead-time volatility	Delays due to upstream capacity	Qualify at least two suppliers and keep safety stock where required
Regulatory documentation gaps	Missing batch traceability documentation	Require full COA and GMP status per lot

Key supplier-selection checklist (for pyridostigmine bromide)

• Confirm grade: USP/EP-compliant vs. chemical vs. analytical.
• Lock specs: assay, identification method, known impurities list, water/solvent residuals (if applicable).
• Require impurity reporting: include limits and analytical method references.
• Batch traceability: lot genealogy and manufacturing site.
• Quality system alignment: GMP status for pharmaceutical-grade supply.

Key Takeaways

• Pyridostigmine bromide supply comes from both API manufacturers and drug product manufacturers, with chemical distributors acting as intermediaries in many regions.
• Best procurement visibility comes from mapping finished-dose labelers/manufacturers and then qualifying upstream API sources with COA, impurity panels, and documentation.
• Supplier qualification should prioritize impurity control, grade verification, and lot traceability, because pyridostigmine bromide quality issues typically present at the impurity/specification level rather than assay alone.

FAQs

1) Who supplies pyridostigmine bromide in finished drug products?

Finished-dose pyridostigmine bromide supply is reflected in U.S. prescribing information that lists the labeler and/or manufacturer of record. Those entities distribute the tablet product that contains the API. (See referenced U.S. prescribing information sources below.)

2) Are pyridostigmine bromide API suppliers the same as drug product suppliers?

Not necessarily. Drug product manufacturers often source the API from separate upstream suppliers, including API manufacturers or chemical producers.

3) What documentation should procurement require for pyridostigmine bromide?

At minimum: per-lot COA, applicable specification sheet, identification/assay and impurity results with method references, and GMP-grade quality documentation when the intended use is pharmaceutical manufacturing.

4) What sourcing risks matter most for pyridostigmine bromide?

Lot-to-lot impurity variation, grade mismatch, documentation gaps, and lead-time volatility from upstream capacity constraints.

5) What grade should be used for generic manufacturing or clinical development?

Use pharmaceutical-grade pyridostigmine bromide that aligns with USP/EP specifications and provides GMP-grade documentation for intended regulatory use.

---

References (APA)

[1] U.S. National Library of Medicine. (n.d.). Pyridostigmine bromide prescribing information and label information (Drug label references in DailyMed/Medline resources). https://dailymed.nlm.nih.gov/
[2] U.S. Food and Drug Administration. (n.d.). Drugs@FDA (labeler/manufacturer information for marketed pyridostigmine bromide products). https://www.accessdata.fda.gov/scripts/cder/daf/