Sodium Cromoglicate Eye Drops 2% (20 mg/mL) 0.4 mL

● Sodium cromoglicate belongs to the group of anti-allergics used in ophthalmology (ATC code S01GX01) [2] ● Inhibits the degranulation of s

Sodium Cromoglicate Eye Drops 2% (20 mg/mL) 0.4 mL product packaging
Ophthalmic

Sodium Cromoglicate Eye Drops 2% (20 mg/mL) 0.4 mL

● Sodium cromoglicate belongs to the group of anti-allergics used in ophthalmology (ATC code S01GX01) [2]
● Inhibits the degranulation of sensitised mast cells after exposure to specific antigens and the release of histamine and membrane-derived mediators of inflammation [1][2]
● Has no intrinsic vasoconstrictor or antihistaminic activity [1][2]
● After topical ocular use, systemic absorption is low; the drug is not metabolised and is excreted unchanged in bile and urine [1][2]
● Sterile aqueous solution, clear colourless to pale yellow, sodium cromoglicate 2% w/v (20 mg/mL), in 0.4 mL single-dose units [1][2]

Product NameSodium Cromoglicate Eye Drops 2% (20 mg/mL) 0.4 mL
Dosage FormOphthalmic
Strength2% (20 mg/mL) 0.4 mL
StandardsBP / ENTERPRISE
PackingCustomized per market requirement (bottle / blister / box)
DocumentsCOA, COPP, DMF, CTD Dossiers
MOQContact us for MOQ and current stock
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WHO Prescribing Guidance

Indications · Administration · Dosage · Precautions

Reference information summarised from WHO prescribing guidance. Expand each item below — clinical use must always follow the locally approved product insert.

🎯Indications▾
● Relief and treatment of seasonal and perennial allergic conjunctivitis [2][3] ● Relief and treatment of allergic conjunctivitis and vernal keratoconjunctivitis (vernal or spring catarrh) [1] ● Use regularly and continue during the period of allergen exposure to ensure optimal control of symptoms [2]
💧Administration▾
● For ocular use only; instil into the conjunctival sac of the affected eye [2] ● Wash hands before use; do not allow the tip of the container to touch the eye or any surface, to avoid contamination [2] ● Single-dose container: sterile and preservative-free — use immediately after opening and discard any remaining contents after use [2] ● Contact lenses should be removed before each application and may be re-inserted after 15 minutes [2] ● When used together with other eye drops, space the instillations by 15 minutes [2]
⚖️Dosage▾
The schedule below refers to the registered sodium cromoglicate eye-drops products; for the single-dose presentation, instil the volume and frequency prescribed in the approved label of the product concerned [1][2]. ● Treatment should be regular and maintained during the allergen season to achieve optimal symptom control [2][3]
⚠️Precautions & Warnings▾
● Contraindicated in patients with hypersensitivity to sodium cromoglicate or to any excipient [1][2] ● Transient stinging and burning may occur after instillation; other symptoms of local irritation and hypersensitivity reactions have been reported (frequency not known) [1][2] ● Multi-dose preparations containing benzalkonium chloride: patients should be advised not to wear soft contact lenses during treatment [1] ● Pregnancy: caution should be exercised, especially during the first trimester; cumulative experience suggests no adverse effects on foetal development; use only where there is a clear need [1][2] ● Breast-feeding: excretion in human milk is considered unlikely; there is no evidence of undesirable effects on the baby [1][2] ● Instillation may cause transient blurring of vision — do not drive or operate machinery until normal vision has been re-established [1][2] ● Storage (single-dose): store below 25 °C before opening, keep the containers in the sachet to protect from light; use immediately after opening [2]. Multi-dose reference: do not store above 30 °C; protect from light; discard 4 weeks after first opening [1] For full prescribing information, refer to the approved product label / Summary of Product Characteristics of the product concerned [1][2][3].

Reference: WHO Model Formulary / WHO Model List of Essential Medicines. For professional reference only — clinical use must follow the locally approved product insert and national treatment guidelines.

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FAQ

Sodium Cromoglicate Eye Drops 2% (20 mg/mL) 0.4 mL — Frequently Asked Questions

Which documents are provided for Sodium Cromoglicate Eye Drops 2% (20 mg/mL) 0.4 mL registration?

Every batch of Sodium Cromoglicate Eye Drops 2% (20 mg/mL) 0.4 mL ships with a Certificate of Analysis (COA). For market registration we provide COPP, DMF and CTD-format dossiers, plus legalisation support where your authority requires it.

What is the MOQ and lead time for Sodium Cromoglicate Eye Drops 2% (20 mg/mL) 0.4 mL?

MOQ and lead time for Sodium Cromoglicate Eye Drops 2% (20 mg/mL) 0.4 mL depend on strength, packaging and destination market. Send us your target market and annual volume — our export team confirms current stock, MOQ and lead time within 24 hours.

Do you support OEM / private label?

Yes. We offer OEM packaging and private-label production for Sodium Cromoglicate Eye Drops 2% (20 mg/mL) 0.4 mL, subject to the regulatory requirements of the destination market.

Which markets have you exported ophthalmic products to?

We have supplied ophthalmic products to 50+ countries across Africa, Southeast Asia, Latin America and the Middle East, with experience in ministry-of-health registration and international tenders.

How is the quality of Sodium Cromoglicate Eye Drops 2% (20 mg/mL) 0.4 mL controlled?

Sodium Cromoglicate Eye Drops 2% (20 mg/mL) 0.4 mL is produced in China-GMP workshops (site re-inspected and passed in 2026), released only after full QC testing against BP / enterprise standards, with retained samples kept for one year beyond the product's expiry date.

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