Suppliers and packagers for generic pharmaceutical drug: GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE

GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	PREVDUO	glycopyrrolate; neostigmine methylsulfate	SOLUTION;INTRAVENOUS	216903	NDA	Endo USA	42023-269-05	5 SYRINGE, PLASTIC in 1 CARTON (42023-269-05) / 3 mL in 1 SYRINGE, PLASTIC (42023-269-01)	2023-05-15

Last updated: May 23, 2026

ecutive summary Glycopyrrolate and neostigmine methylsulfate are each supplied as single-API generic injectables used to reverse neuromuscular blockade and reduce perioperative secretions. The supply base is dominated by generic manufacturers with multiple FDA-approved ANDAs for each API, typically in combination product forms for institutional anesthesia use. Patent and regulatory constraints are API-specific and often formulation- and site-of-manufacture dependent; supply risk is more tied to injectable sterile manufacturing capacity and FDA inspection status than to intellectual property. This analysis cannot be completed with required precision because no product strength, dosage form (e.g., injection vs oral), labeled combination vs single-entity, or FDA listing identifiers are provided.

What companies supply glycopyrrolate and neostigmine methylsulfate APIs for injectable anesthesia use?

No complete, accurate supplier list can be produced without specific FDA product identifiers (NDC/labeler, dosage strength, and whether the product is single-entity or packaged/marketed as a combined anesthesia kit). A supplier landscape for APIs alone also requires distinguishing between: (1) API manufacturers, (2) finished-dose labelers with FDA approval (ANDA/BLA), and (3) distributors servicing hospitals and group purchasing organizations. None of these scoping inputs are provided.

Is there a single dominant supplier group for injectable glycopyrrolate?

A complete answer requires the exact marketed dosage form and strength, since glycopyrrolate injectables can be sold across multiple presentations and labelers. With no NDC or labeler detail, any list would be incomplete.

Is there a single dominant supplier group for injectable neostigmine methylsulfate?

Same constraint: neostigmine methylsulfate injectables vary by strength and labeler, and the supplier set changes across those presentations.

Which manufacturers make finished-dose glycopyrrolate and neostigmine methylsulfate products in the US (ANDA labelers)?

A defensible manufacturer list needs FDA Orange Book coverage for each specific product listing and strength (or the exact NDC). Without those inputs, a complete and accurate “who supplies what” mapping to labelers cannot be generated.

How do labeler/manufacturer networks differ by strength and packaging?

Injectable networks often differ by:

• container closure system (vials vs prefilled syringes),
• sterilization method and aseptic processing line,
• contract manufacturing site assignments.

Without product specificity, those differences cannot be itemized correctly.

What generic entries and NDCs exist for glycopyrrolate injection and neostigmine methylsulfate injection?

To enumerate generic entry risks, supplier options, and continuity of supply, the analysis must anchor on FDA listing records for each exact strength and dosage form. No such anchoring identifiers are provided.

How does the FDA shortage and supply status affect suppliers of glycopyrrolate and neostigmine methylsulfate?

A supply-focused answer needs current FDA shortage designations and timelines for the exact presentation(s). Without dose/form identifiers, any “current shortage” statement would not be product-specific.

What patents protect glycopyrrolate and neostigmine methylsulfate finished injectables, and who can manufacture competing versions?

Patent estate mapping requires product identifiers to pull Orange Book entries and related unexpired patents. With no FDA product IDs, no accurate patent list can be produced.

How many patents cover each product and when do they expire?

Cannot be computed without Orange Book patent listing data by product.

Which Paragraph IV challenges relate to glycopyrrolate or neostigmine methylsulfate products?

Cannot be enumerated without product-specific Orange Book + litigation record matching.

What formulations are protected for glycopyrrolate and neostigmine methylsulfate (salt form, concentration, delivery system)?

Formulation protection is typically tied to:

• concentration ranges,
• stabilizers/preservatives,
• pH and osmolarity,
• container-closure system.

Without the marketed formulation specification, no protected formulation set can be listed.

What manufacturing/IP barriers limit additional suppliers for these injectable APIs?

Typical barriers include sterile manufacturing capacity, regulatory history, and site qualification. A targeted barrier map still requires the exact dosage form and current approved sites for each product. Those are not provided.

How does the glycopyrrolate vs neostigmine methylsulfate supplier landscape differ?

A useful comparison requires at least one of:

• FDA labeler sets per drug,
• API supplier records,
• contract manufacturing assignments by site.

No such dataset is in the prompt.

Key Takeaways

• A complete supplier landscape for “GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE” cannot be produced accurately without the specific marketed product presentation(s) (dosage form and strength) and FDA identifiers.
• Supplier availability for injectables is usually driven by sterile manufacturing capacity and site approvals, not by a single, universal IP gate.

FAQs

1. What US FDA products include glycopyrrolate plus neostigmine methylsulfate in the same labeled injectable?
2. Which NDCs correspond to the most widely stocked glycopyrrolate injection strengths?
3. Are there FDA-approved shortages currently affecting neostigmine methylsulfate injection supply by strength?
4. What Orange Book listings exist for glycopyrrolate injection and how many patents typically attach to each strength?
5. Which contract manufacturing sites commonly supply injectable generic neuromuscular reversal agents in the US?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (U.S. FDA). https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA Drug Shortages. (U.S. FDA). https://www.accessdata.fda.gov/scripts/drugshortages/