Epinastine bulk supplier for pharma manufacturers

Epinastine 0.05% Suppliers & Bulk Manufacturers

Available Forms: Eye Drops

Available Strengths: 0.05%

Reference Brands: Elestat®(US), Relestat®(EU)

Epinastine 0.05% eye drops, a sterile antihistamine and mast cell stabiliser solution for allergic conjunctivitis, listed for importers, distributors, hospital pharmacies and ophthalmic wholesalers.

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Product Description:

Epinastine hydrochloride 0.05% is a sterile eye drop solution for allergic eye disease. Epinastine blocks histamine H1 receptors and also stabilises mast cells, so it relieves itching that has started and damps further release of histamine from the conjunctiva. Systemic exposure after topical use is low. The drop form delivers the medicine straight to the eye surface, where allergy causes itching, redness and watering, and spares patients the drowsiness some oral antihistamines bring.

It is used to prevent and relieve itching in allergic conjunctivitis, one drop in each affected eye twice daily while allergen exposure lasts. The lower age limit differs between labels, so pharmacists check local product information before supplying it for children. Many presentations contain benzalkonium chloride, so soft contact lenses are removed before use and refitted after 10 to 15 minutes. Red eyes from infection or lens irritation are not an indication. Brief stinging on instillation is among the commoner effects.

Sourcing notes. Epinastine eye drops are prescription-only in most markets. Expect a CTD or ACTD dossier with sterility assurance, preservative efficacy and container closure data, plus stability for your climatic zone, zone IVb for hot humid countries. The usual pack is an LDPE dropper bottle with a tamper-evident cap, and the label states how long it may be used after opening. No cold chain is needed. Request a CoA per batch with sterility, pH, osmolality and assay, the GMP certificate for sterile manufacture and a CoPP. State fill volume, preservative choice and carton language.

Epinastine — third party manufacturing & bulk supply

Epinastine 0.05% is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Epinastine is supplied as Eye Drops — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Epinastine listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Epinastine is used to relieve symptoms of allergic conjunctivitis, such as itching, redness, and watering of the eyes caused by seasonal allergies. It helps by blocking histamine, a natural substance in the body that causes allergic symptoms.

Epinastine is made from Epinastine hydrochloride, which is a selective H1 receptor antagonist and mast cell stabilizer.

The common trade name of Epinastine is Elestat.

Epinastine (Elestat) is manufactured by Allergan, Inc. and co-promoted by Inspire Pharmaceuticals.

The generic name of Epinastine is Epinastine hydrochloride.

The brand name of Epinastine is Elestat.

Epinastine is manufactured in the United States and also by licensed pharmaceutical companies in Japan and Europe under respective regulatory approvals.