Latanoprost, a prostaglandin F2α analogue, is widely used to treat glaucoma and ocular hypertension. Its effectiveness, low dosage, and once-daily use make it a preferred ingredient in many ophthalmic formulations.
As global demand for generic Latanoprost eye drops continues to rise, pharmaceutical companies, distributors, and CMOs must increasingly navigate the complex regulatory landscape involved in sourcing this high-value API from manufacturing hubs like India or China. To ensure successful market entry, buyers need a clear understanding of the compliance pathway, documentation requirements, and customs procedures involved in cross-border pharmaceutical trade.
In this comprehensive guide, we walk you through exactly how to import Latanoprost API to the US and Europe—from regulatory filings and GMP requirements to document verification and export readiness—so you can minimize delays, reduce compliance risks, and source with confidence.
1. Why Is Regulatory Compliance Important for Latanoprost API?
Latanoprost formulations are classified as prescription drugs in the US and Europe. Therefore, the active pharmaceutical ingredient (API) must be:
- Manufactured under GMP-compliant conditions
- Supported by regulatory documentation (DMF, CEP, ASMF)
- Properly labeled, tested, and packaged
- Registered or declared in the importer’s dossier submission
Without these, APIs are blocked at customs or rejected by health authorities like the FDA or EMA.
Explore a leading manufacturer of APIs.
With over 10 years of expertise, we ensure GMP compliance and provide reliable, high-quality solutions.
2. How to Import Latanoprost API into the United States
✅ A. Type II DMF (Drug Master File)
The US FDA requires that your supplier submits a Type II DMF for Latanoprost API.
You must request:
- DMF number
- Letter of Access (LoA)
- Open part of the DMF (for your product registration)
FDA will reference the DMF during ANDA or NDA filing.
✅ B. FDA Facility Registration
Your API supplier must:
- Be registered with the FDA
- Be ready for audit or have undergone previous inspections
- Ensure validated GMP systems and records
✅ C. Required Documents for US Import
| Document | Why It’s Needed |
|---|---|
| CoA (Certificate of Analysis) | Verifies purity, assay, and compliance |
| GMP Certificate | Confirms manufacturing standards |
| MSDS | Ensures safe handling and transport |
| Impurity Profile | Shows control of degradation and related compounds |
| Stability Data | Validates shelf life during transit and storage |
| TSE/BSE Declaration | Required for ophthalmic use safety |
| Labeling & Packaging | Must follow FDA import labeling standards |
| Commercial Invoice | For customs clearance |
✅ All documents must be included with the shipment and submitted to the FDA Import Division if requested.
3. How to Import Latanoprost API into Europe
✅ A. CEP (Certificate of Suitability) or ASMF
The European Medicines Agency (EMA) or national authorities require:
- A valid CEP (issued by EDQM), or
- An Active Substance Master File (ASMF) submission
If your API supplier provides a CEP, it is accepted across all EU countries. Otherwise, you’ll need:
- ASMF (Open & Closed parts)
- Written confirmation from the exporting country’s authority (India, etc.)
Chemignition provides ASMF support for Latanoprost API buyers in Europe.
✅ B. EU-GMP Certification
If the API is made outside the EU (e.g. in India), the manufacturer must:
- Undergo EU-GMP inspection, or
- Provide audit documentation accepted by EU authorities
✅ C. Importer Responsibilities
The importer must:
- Obtain authorization for pharmaceutical imports.
- Conduct a site audit or review documentation to validate GMP compliance.
- Use the API only in products that comply with approved Marketing Authorizations (MA).
4. Packaging, Labeling & Logistics Compliance
Whether you’re importing into the US or Europe, your shipment must meet specific handling and documentation requirements:
| Packaging Element | Requirement |
|---|---|
| Primary Packaging | Light-protective, moisture-sealed container |
| Labeling | Batch number, expiry date, GMP site, net weight |
| Shipping Docs | Invoice, packing list, airway bill, CoA, MSDS |
| Storage Conditions | Refrigerated -20°C to -10°C., with stability support |
| Courier Requirements | Use validated pharma carriers with GDP compliance |
⚠️ Tip: Pre-inspect packaging if importing to countries with strict customs inspections (e.g., Germany, US ports).
5. Common Import Mistakes to Avoid
| Mistake | Why It’s Risky |
|---|---|
| Using API without DMF or CEP | Regulatory rejection during product registration |
| Outdated or missing CoA/MSDS | Shipment may be detained at customs |
| Incomplete LoA or open part of ASMF | EMA or FDA may refuse reference |
| Buying from non-GMP-certified manufacturers | High risk of audit failure and compliance violations |
✅ Partnering with a DMF-ready and GMP-compliant manufacturer is critical to avoid delays and legal issues.
Chemignition Laboratory: Your Latanoprost API Import Partner
Chemignition Laboratory manufactures and exports Latanoprost API with full regulatory support for both global markets.
What We Provide:
- GMP certified API production
- CoA, MSDS, impurity profile, TSE/BSE declaration
- Stability data
- Customs-compliant packaging and export documentation
- Global shipping (air/sea, temperature-controlled options)
📦 We support:
- Generic drug manufacturers
- Ophthalmic CMO partners
- API traders and resellers
- Branded product developers
Conclusion
Importing Latanoprost API into the US and Europe is straightforward — if you follow the proper regulatory steps. From securing a DMF or CEP to managing customs documentation and GMP audits, success depends on your supplier’s transparency and technical support.
By partnering with a compliance-focused manufacturer like Chemignition Laboratory, you ensure a smoother regulatory process and a trusted, long-term API supply chain.
📢 Contact Chemignition Laboratory to Import GMP-certified Latanoprost API.
- GMP compliant
- CoA, Stability data and full export documents
- Fast international delivery
FAQs
What documents are required to import Latanoprost API into the US?
You’ll need a valid Type II DMF filed with the US FDA, a Letter of Access (LoA), CoA, GMP certificate, MSDS, impurity profile, and stability data. These documents are essential for product registration and customs clearance.
Can I import Latanoprost API into the EU without a CEP?
Yes, if the supplier doesn’t have a CEP, you can use an ASMF (Active Substance Master File). However, some EU markets prefer a Certificate of Suitability (CEP) as it simplifies approval across all member states.
Does the Latanoprost API supplier need EU-GMP certification for European imports?
Yes, if the manufacturer is outside the EU, the supplier must either have EU-GMP certification or undergo an acceptable audit approved by European authorities.
What’s the difference between a DMF and an ASMF for Latanoprost API?
A DMF (Drug Master File) is submitted to the US FDA, while an ASMF is used for EU market submissions. Both contain confidential manufacturing and quality control data, but they follow region-specific formats and requirements.
How does Chemignition support global buyers of Latanoprost API?
Chemignition provides GMP-certified Latanoprost API, full documentation, and export-ready support for buyers in the worldwide. We ensure compliance, offer packaging customization, and assist with technical and regulatory queries.
