Description
Atropine Sulfate Ophthalmic Solution (0.01% / 1.0% w/v)
Healthy Inc is a specialized global supplier and exporter of advanced ophthalmology, pediatric vision care, and targeted autonomic therapeutics. We provide ultra-high-purity, kinetically stabilized Atropine Sulfate Eye Drops, manufactured in WHO–GMP certified, high-precision sterile ophthalmic facilities. This “Antimuscarinic Anticholinergic” is a strategic export to eye hospitals, pediatric clinics, and government health ministries, serving as the globally mandated intervention for cycloplegia, mydriasis, and the clinical management of childhood myopia.
Product Overview
This formulation operates as a “Neuromuscular Signaling Blocker.” It physically prevents the neurotransmitter acetylcholine from reaching the receptors in the eye, leading to the temporary relaxation of internal eye muscles and dilation of the pupil.
Mechanism 1 (Mydriasis – Pupil Dilation): Atropine physically blocks the muscarinic receptors in the sphincter pupillae muscle. This causes the pupil to dilate widely, allowing for thorough examination of the retina and posterior segment.
Mechanism 2 (Cycloplegia – Focus Paralysis): It physically inhibits the ciliary muscle, temporarily paralyzing the eye’s ability to focus (accommodation). This is critical for determining accurate refractive errors in young children.
Mechanism 3 (Myopia Control – The Growth Signal): In low doses (0.01%), it is believed to physically slow the axial elongation of the eyeball. By preventing the eye from growing too long, it significantly reduces the progression of nearsightedness in children.
Product Composition & Strength
We supply this product in a Sterile, Buffered, Isotonic Aqueous Solution, optimized for comfort and maximum stability.
| Active Ingredient | Strength (w/v) | Primary Clinical Function |
| Atropine Sulfate USP/BP | 0.01% (Low Dose) | The Myopia Controller: Slows nearsightedness in children. |
| Atropine Sulfate USP/BP | 1.0% (Standard) | The Cycloplegic: For surgery, dilation, and uveitis. |
| Excipients | Benzalkonium Chloride / NaCl | The Sterile Matrix: Preserved and pH-balanced for eye safety. |
Technical & Logistics Specifications
HS Code: 3004.90.99 (Medicaments acting on the nervous system / Ophthalmic)
CAS Number: 5908-99-6 (Atropine Sulfate Monohydrate)
Dosage Form: Sterile Eye Drops (Ophthalmic Solution)
Packaging: Sterile LDPE Dropper Bottles (5ml / 10ml) with tamper-evident caps. Our specialized ophthalmic packaging ensures stability and sterility throughout the shelf life in Zone IVb tropical climates.
Manufacturing Authority & Compliance
Aseptic Filling Excellence: Our manufacturing process utilizes Class 100 (ISO 5) Sterile Filling Lines. This ensures the solution is 100% free from microbial contaminants, a critical requirement for any medication applied to the ocular surface.
Isotonicity & pH Precision: We utilize Advanced Buffering Systems to ensure the drops match the natural pH and salinity of human tears (pH 7.4). This minimizes the “stinging” sensation, which is essential for pediatric patient compliance.
Primary Indications
Pediatric Ophthalmology: Clinical management of Myopia Progression in children (Low Dose).
Diagnostic Eye Exams: Achieving maximum Mydriasis and Cycloplegia for refraction and fundus examination.
Surgery: Pre-operative dilation for certain ophthalmic procedures.
Therapeutic: Treatment of Acute Uveitis and Iritis to prevent posterior synechiae (internal scarring).
Dosage & Administration
For Myopia Control: Typically one drop in each eye daily at bedtime.
For Dilation: 1 drop applied 30–60 minutes prior to examination.
Administration: Apply to the conjunctival sac. To minimize systemic absorption, the patient should apply pressure to the tear duct (nasolacrimal occlusion) for 1–2 minutes after instillation.
Safety Warning: For Ophthalmic Use Only. Vision Warning: Standard 1% drops cause blurred vision and light sensitivity; patients should not drive or operate machinery until effects wear off. Pediatric Caution: Monitor for systemic side effects (dry mouth, rapid pulse). Contraindication: Do not use in patients with Primary Glaucoma or a narrow anterior chamber angle.
Global Export & Contract Manufacturing
Healthy Inc is a premier Ophthalmic and Pediatric Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-volume sterile eye drops. Whether you are a Specialized Eye Hospital in the Middle East or a B2B Pharma Marketplace partner in the CIS, SE Asia, or Africa, we ensure secure, WHO-GMP compliant delivery.
Commercial Inquiries:
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
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