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Exporting pharmaceutical eye drops and nasal drops is a specialized branch of pharmaceutical trade. These products are sterile liquid formulations intended for direct application to sensitive tissues (the eye or nasal mucosa), so they face stricter quality, packaging, and regulatory controls than many other dosage forms.
Below is a detailed guide you can adapt if you plan to export these products from India (principles are similar elsewhere).
| Category | Examples | Key Characteristics |
|---|---|---|
| Eye Drops (Ophthalmic Solutions/Suspensions) | Antibiotic drops, anti-allergy drops, lubricating/artificial tears, glaucoma treatments | Must be sterile, often preservative-free or single-dose units. |
| Nasal Drops/Sprays | Decongestants, saline solutions, steroid sprays, anti-allergy formulations | Isotonic, non-irritating, microbiologically clean or sterile depending on product. |
WHO-GMP / EU-GMP / US FDA compliant facilities.
Sterile manufacturing using aseptic processing or terminal sterilization.
Validated cleanrooms (Class 100/ISO 5 areas) for filling.
Water-for-Injection (WFI) systems validated for microbiological purity.
Import Export Code (IEC) for Indian exporters.
Drug Manufacturing Licence (Form 28/28D in India for sterile products).
Certificate of Pharmaceutical Product (CoPP) or Free Sale Certificate from local FDA.
Certificate of Analysis (CoA) per batch (assay, pH, sterility, particulate matter, preservative content if used).
Stability data (accelerated and real-time) to prove shelf life.
Many importing nations require product registration before the first shipment. Dossier typically includes:
Product formula and specifications
Manufacturing process and validation data
Packaging and labeling details
Bioequivalence/clinical data if applicable
Primary container: Low-density polyethylene (LDPE) or sterilizable plastic bottles with dropper tips or single-use vials.
Tamper-evident caps and lot/batch numbers.
Light-protective packaging for photosensitive products.
Labeling must match the importing country’s language and regulatory format (storage instructions, manufacturer, expiry date, etc.).
Temperature control: Many eye/nasal drops require cold-chain (2–8 °C) shipping.
UN-compliant packaging for air freight if the product is classified as hazardous (e.g., flammable solvents).
Ensure Good Distribution Practices (GDP): data-logged temperature monitoring, validated shipping containers.
High-growth regions: Middle East, Africa, Latin America, Southeast Asia—especially for generic antibiotic or anti-allergy eye drops and saline nasal sprays.
Countries with limited sterile manufacturing capacity often import large volumes.
Identify Products & Strengths
Choose formulations where your plant already has sterility expertise.
Register with Pharmexcil (India-specific)
Membership helps with market intelligence and participation in international trade fairs.
Select Target Countries & Research Regulations
Check specific regulatory authorities (e.g., Saudi FDA, South Africa SAHPRA, EU EMA national agencies).
Prepare & Submit Dossier
Compile CTD/ACTD dossiers for each product as required.
Arrange Buyer Agreements & Payment Terms
Use Letters of Credit or secured payment methods.
Plan Cold-Chain Logistics
Partner with freight forwarders experienced in pharmaceutical temperature-controlled shipments.
