ASEAN desk
Pharmaceutical export from India to ASEAN and South-East Asia
WHO-GMP sourced formulations for ACTD-format markets, quoted to Manila, Ho Chi Minh City, Jakarta, Port Klang and Laem Chabang.
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WHO-GMP sourcedOverview
Exporting pharmaceuticals from India to ASEAN
RND Industries supplies finished pharmaceutical formulations and surgical disposables from WHO-GMP certified Indian manufacturing sites to importers and distributors across South-East Asia. ASEAN is the one region that does not run on the ICH CTD alone: most member states register on the ASEAN Common Technical Dossier (ACTD), which is a real difference to plan your filing around. RND Industries is a merchant exporter — the registration is filed and held by you, and we do not act as your regulatory agent. What we can do is ask our manufacturing partner for the documents your submission needs and pass on what the site issues.
Markets we quote into
- Philippines
- Vietnam
- Indonesia
- Malaysia
- Thailand
- Cambodia
- Myanmar
- Laos
- Singapore
What your registration involves
- Most ASEAN member states register on the ACTD format (Parts I–IV), not the ICH CTD used elsewhere.
- Some importing authorities accept or require the ICH CTD instead — confirm which your regulator wants.
- A Certificate of Pharmaceutical Product (CPP) in WHO format is commonly requested as part of the file.
- ASEAN GMP evidence and site master file extracts are asked for by some authorities.
- Indonesia and Malaysia may additionally require halal certification, depending on the product.
Authorities you file your registration with
RND Industries is a merchant exporter, not a regulatory agent. We do not provide registration or compliance services and we are not the marketing authorisation holder in any of these markets — the filing is yours as the importer. The list below is market information so you know who you are dealing with. Where your submission needs a document from the manufacturing side, we request it from our manufacturing partner and forward what that site can issue.
- Philippine FDA · Philippines
- Drug Administration of Vietnam (DAV) · Vietnam
- BPOM · Indonesia
- NPRA · Malaysia
- Thai FDA · Thailand
Logistics
Shipping routes and ports
Indicative sea transit is roughly 2–4 weeks from Indian west-coast ports, typically via Singapore or Port Klang transshipment. Air freight is arranged for samples, registration batches and urgent consignments. Actual transit is confirmed per shipment at quotation.
We load from
- Nhava Sheva
- Mundra
- Hazira (Surat)
We quote to (ASEAN)
- Manila (Philippines)
- Cat Lai and Hai Phong (Vietnam)
- Tanjung Priok, Jakarta (Indonesia)
- Port Klang (Malaysia)
- Laem Chabang (Thailand)
- Singapore
- Sihanoukville (Cambodia)
- Yangon (Myanmar)
Documentation, to your requirement
- Tell us which documents your market and your regulator ask for.
- We request them from the manufacturing partner that supplies your product.
- Whatever that site can issue for your product, we obtain and forward.
- The confirmed document list is written into your quotation before you order — we do not promise paperwork the manufacturer has not agreed to.
Commercial terms — ASEAN
- Quotes on FOB, CIF or DDP terms, in USD.
- Local-language artwork coordination — Bahasa Indonesia, Bahasa Malaysia, Vietnamese, Thai and Filipino — with the manufacturing site.
- Registration and stability batches supplied ahead of commercial volumes.
- Institutional and tender supply supported with bid documentation packs.
Answers
ASEAN export — frequently asked questions
What is the difference between CTD and ACTD for ASEAN registration?
The ICH CTD is the international five-module dossier format used across most regulated markets. The ASEAN Common Technical Dossier (ACTD) is the four-part format adopted by ASEAN member states — Administrative, Quality, Non-clinical and Clinical. Which one you file depends on your authority: the Philippine FDA, DAV, BPOM, NPRA and Thai FDA each publish their own requirement. Compiling that submission is the importer’s job, not ours — we are a merchant exporter and do not provide regulatory-affairs services.
How do I import medicines from India to the Philippines or Vietnam?
Send your product list, quantities and destination. We quote within 24 hours from WHO-GMP certified sources. The import licence and the Philippine FDA or DAV registration are yours to obtain — we do not file for you. Tell us which documents your submission requires and we request them from the manufacturing partner supplying your product, confirming on the quotation what that site can provide.
Which ASEAN ports do you ship to?
We quote from Nhava Sheva, Mundra and Hazira to Manila, Cat Lai and Hai Phong, Tanjung Priok, Port Klang, Laem Chabang, Singapore, Sihanoukville and Yangon, usually via Singapore or Port Klang transshipment.
Send your product list for ASEAN
Tell us the molecules, strengths, pack sizes and destination market. We quote within 24 hours and confirm which documents are available per product. No login required — or write to [email protected].