Suppliers and packagers for ATROPINE SULFATE

ATROPINE SULFATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	214752	ANDA	A-S Medication Solutions	50090-7313-0	1 BOTTLE, DROPPER in 1 CARTON (50090-7313-0) / 5 mL in 1 BOTTLE, DROPPER	2022-07-19
Amneal	ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	214752	ANDA	Amneal Pharmaceuticals NY LLC	60219-1748-2	1 BOTTLE, DROPPER in 1 CARTON (60219-1748-2) / 2 mL in 1 BOTTLE, DROPPER	2022-07-19
Amneal	ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	214752	ANDA	Amneal Pharmaceuticals NY LLC	60219-1749-3	1 BOTTLE, DROPPER in 1 CARTON (60219-1749-3) / 5 mL in 1 BOTTLE, DROPPER	2022-07-19
Amneal	ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	214752	ANDA	Amneal Pharmaceuticals NY LLC	60219-1750-8	1 BOTTLE, DROPPER in 1 CARTON (60219-1750-8) / 15 mL in 1 BOTTLE, DROPPER	2022-07-19
Apotex	ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	215624	ANDA	A-S Medication Solutions	50090-7000-0	1 BOTTLE, DROPPER in 1 CARTON (50090-7000-0) / 5 mL in 1 BOTTLE, DROPPER	2021-11-26
Apotex	ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	215624	ANDA	Apotex Corp.	60505-6226-0	1 BOTTLE, DROPPER in 1 CARTON (60505-6226-0) / 2 mL in 1 BOTTLE, DROPPER	2021-11-26
Apotex	ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	215624	ANDA	Apotex Corp.	60505-6226-1	1 BOTTLE, DROPPER in 1 CARTON (60505-6226-1) / 5 mL in 1 BOTTLE, DROPPER	2021-11-26

Atropine Sulfate: Supplier Landscape for Pharmaceutical Manufacturing

Last updated: April 23, 2026

Which companies supply atropine sulfate for pharma use?

No reliable, complete supplier list can be produced from the information provided.

What supplier categories matter for procurement of atropine sulfate?

For pharmaceutical supply, buyers typically segment sources into:

• API manufacturers (atropine sulfate as active pharmaceutical ingredient)
• Finished-dose and sterile product suppliers (atropine sulfate as drug product, often via contract manufacturing)

What sourcing artifacts confirm a viable supplier for pharma?

Procurement-grade sourcing typically relies on:

• Drug Master File (DMF) or equivalent regulatory dossier access
• GMP certification for the manufacturing site
• Pharmacopoeial compliance (typically USP/EP monographs for atropine sulfate)
• Quality agreements covering change control, specs, impurities, and batch disposition

What is the current market reality for atropine sulfate sourcing?

Atropine sulfate is a controlled and safety-critical medicine used across multiple therapeutic and emergency contexts. Supply chain continuity is driven by:

• API site capacity and sterility/quality capability (for drug product)
• Regulatory status (site approvals and dossier readiness)
• Long lead times for batch testing, release, and stability programs

How should procurement teams screen suppliers for atropine sulfate?

A practical screening workflow focuses on:

• Regulatory readiness: DMF access or site authorization pathways
• Quality metrics: impurity profile control, water content/assay specs, and deviation history
• Manufacturing proof: batch records availability under NDA, CAPA responsiveness
• Commercial terms: supply continuity, minimum order quantities, lead times, and pricing structure

Key Takeaways

• A complete, accurate supplier list for atropine sulfate cannot be generated from the provided input.
• Pharma-grade sourcing depends on API or drug-product category, plus regulatory and GMP evidence (DMF access, site certifications, pharmacopoeial compliance).
• Procurement should screen on regulatory readiness, quality metrics, manufacturing proof, and supply continuity terms.

FAQs

1. Is atropine sulfate sourced primarily as API or as finished drug product?
   Both models exist, but procurement strategy depends on whether the buyer manufactures internally or distributes finished sterile/non-sterile product.

2. What documents typically matter most when qualifying atropine sulfate suppliers?
   DMF or regulatory dossier access, GMP site certifications, pharmacopoeial compliance evidence, and quality agreement terms.

3. What quality attributes are most scrutinized for atropine sulfate?
   Assay, impurity profile, and batch release controls aligned to the relevant pharmacopoeial monograph.

4. Does supplier selection differ for emergency/sterile use?
   Yes. Sterile drug product supply requires sterility assurance and additional controls beyond API-level GMP.

5. How can buyers reduce supply disruption risk for atropine sulfate?
   Use dual sourcing where possible, confirm stability and batch release capability, and lock change-control terms in advance.

References (APA)
No cited sources are available from the provided information.