When Indian pharmaceutical companies want to export to Cambodia, they must meet Cambodia’s FDA / regulatory requirements clearly and fully. Only then can you be trusted by Cambodian pharmaceutical medicine suppliers, distributors, and local brands. In this blog, we explain how Indian manufacturers can ensure compliance with Cambodian FDA (or Ministry of Health) rules. We also show why Aliyan Pharmaceuticals, as a pharmaceutical medicine exporter for Cambodia, third party mfg pharmaceutical products, and WHO GMP certified third party manufacturers, is a strong partner for importers, distributors, and brands in Cambodia.
Why Compliance Matters in Cambodia
Cambodia’s pharmaceutical market imports over half of its medicines. Only companies licensed by the Ministry of Health may import drugs, medical supplies, or medical equipment. The Law on the Management of Pharmaceuticals in Cambodia requires that any business doing import, export, or manufacturing of pharmaceuticals must have authorization, follow good practices, and register products.
If an exporter fails regulatory compliance, consequences include rejection at customs, fines, suspension of operations, or even legal penalties. Therefore, Indian firms must rigorously plan for compliance.
Key Cambodian Regulatory Requirements for Pharmaceuticals
Below are the key regulatory steps and requirements Indian manufacturers must satisfy to export or contract manufacture pharmaceutical products into Cambodia.
1. Register as an Overseas Manufacturer with Cambodia MOH
Under Prakas No. 003 on the Procedures and Conditions of the Submission of the registration of Pharmaceutical Manufacturer from Overseas, foreign pharmaceutical manufacturers must register with Cambodia’s Ministry of Health (MOH).
- You must submit an application including:
- Administrative documents (company registration, certificates)
- Technical documents (manufacturing process, quality systems, batch records)
- A valid GMP certificate (or WHO GMP compliance) issued by a recognized authority
- Validation that your GMP certificate is valid for at least six months at time of submission
- Cambodia also demands that import/export companies and representative offices first be registered as pharmaceutical manufacturers.
2. Product Registration via CamPORS / DDF
- Cambodia uses a digital platform called CamPORS (Cambodia Pharmaceutical Online Registration System) for registration of therapeutic drugs, health supplements, cosmetics, etc.
- For drugs and therapeutic products, you often submit a dossier following the ASEAN Common Technical Dossier (ACTD) model. Imported medicines must undergo laboratory testing under MOH.
- Regulatory timelines may vary. In practice, registration of generic drugs may take 3 to 6 months under normal circumstances.
3. Ensure Product Validity and Label Requirements
Cambodia requires that imported pharmaceuticals have sufficient remaining shelf life — often at least 18 months of validity at time of entry. Labels must comply with Cambodian rules, often in English and local language (Khmer) where required, and include manufacturing details, batch numbers, expiry, storage conditions, etc.
4. Licenses of Importers & Pharmacist Requirements
Only licensed local companies can act as importers or distributors of pharmaceuticals. A qualified pharmacist must be involved in such importation, per Cambodian law.
5. Customs, Declaration & Import Requirements
- All goods entering Cambodia must file customs declarations and pay duties/taxes.
- Pharmaceuticals must typically be accompanied by import permits, registration certificates, Certificates of Analysis, and related documentation.
- Certain categories (narcotics, psychotropic substances, toxic chemicals) are restricted and may be prohibited.
6. Compliance with Local Good Manufacturing Practice (GMP) & Audits
- Cambodia expects pharmaceutical manufacturing sites (whether overseas or local) to conform to GMP standards. A valid GMP certificate is mandatory in the overseas manufacturer registration step.
- Local or third-party audits may also be required. This ensures quality, safety, consistency, and traceability.
How Indian Pharma Manufacturers Can Prepare for Compliance?
To meet the Cambodian regulatory requirements smoothly, here are practical steps Indian pharmaceutical firms should take:
Obtain or Maintain WHO / International GMP Certification
Be a who gmp certified third party manufacturers or certify your facility under recognized GMP bodies. This is central to acceptance by Cambodian authorities.
Document Everything Thoroughly
Have complete standard operating procedures (SOPs), validation records, stability studies, quality control records, batch records, equipment qualification, and audit reports.
Engage Regulatory Experts Early
Use local Cambodian regulatory consultants or partners familiar with DDF/MOH processes and CamPORS. This avoids mistakes in submissions, language or formatting issues.
Plan for Dossier in ASEAN / ACTD Format
Prepare product dossiers in ASEAN Common Technical Dossier style, which Cambodian MOH uses. This speeds up acceptance.
Choose Reliable Cambodian Distributors / Local Agents
Work with trustworthy pharmaceutical medicine suppliers in Cambodia who can register products locally, hold licenses, handle importation, warehousing, and distribution.
Pilot / Small Batches First
Begin with small batch exports once registration is underway. Monitor regulatory feedback, client reception, and compliance before scaling up.
Maintain Transparency & Compliance Post-Approval
After product approval, continue to submit post-market reports, ensure lab test consistency, and renew registrations as needed.
Why Engage Aliyan Pharmaceuticals as Your Partner for Cambodia?
When you seek a partner for export, distribution, third-party manufacturing or supply into Cambodia, Aliyan Pharmaceuticals offers a compelling value proposition:
- We are a reliable pharmaceutical medicine exporter for Cambodia, with experience in regulatory, export, and supply chain.
- We act as one of the pharmaceutical suppliers in India capable of flexible volumes, prompt supply, and compliance.
- We offer third party mfg pharmaceutical products services. Whether you need a contract manufacturing model or outsource your pharma production, we can deliver.
- We are counted among top 10 third party manufacturing pharma companies in India by reputation in certain categories (you can verify via references or directories).
- We are recognized as who gmp certified third party manufacturers (or operate under strict GMP standards), thus compliant with Cambodian expectations.
You can explore our full pharmaceutical manufacturing capabilities here:
• https://aliyanpharma.com/pharmaceuticals-manufacturing/
• See our third-party manufacturing services here: https://aliyanpharma.com/third-party-pharmaceutical-products-manufacturing/
By partnering with Aliyan, you benefit from end-to-end support—from regulatory dossier preparation, GMP-compliant production, export logistics, to after-sales service for your Cambodian customers.
Let’s Start Your Cambodia Journey Together
If you are a Cambodian import company, pharmaceutical distributor, local brand, or a foreign buyer seeking third party manufacturing pharma products from India, Aliyan Pharmaceuticals is ready to assist you.
- Request a free consultation to assess your product’s regulatory path for Cambodia
- Ask us for sample dossiers or audit reports to evaluate our compliance
- Explore contract manufacturing options or full supply arrangements
- Partner in co-branding, regional distribution, and regulatory support
Don’t risk delays or rejection due to regulatory missteps. Work with a WHO GMP certified third party manufacturer you can trust. Contact Aliyan Pharmaceuticals today at info@aliyanpharma.com to kickstart your Cambodia pharmaceutical business with confidence and compliance.