Pharmaceutical exporter to Vietnam

Yes. The Drug Administration of Vietnam accepts WHO-GMP certification from Indian manufacturing sites as part of its dossier review, provided the certificate is current, issued by a recognised competent authority, and accompanied by the manufacturing licence and recent inspection observations. We file the WHO-GMP certificate in Module 1 of the ACTD submission with notarised Vietnamese translation, and we maintain a tracker of GMP renewal dates so the registration cover never lapses. EU-GMP certification, which several of our source plants also hold, is an additional positive that DAV reviewers note during evaluation, particularly on oncology and biologic submissions.

DAV target timelines for a complete ACTD dossier are typically nine to twelve months for new generic registrations and twelve to eighteen months for biologics, but real-world timelines depend heavily on dossier completeness at first submission and on the volume of clarification queries. Our experience is that a well-prepared ACTD file with clean Vietnamese translation, complete Zone IVb stability, and proper labelling artwork typically clears in roughly the lower half of that range. Where we have already filed the same molecule in another ASEAN market, we can compress the authoring phase considerably because the underlying technical content is reusable.

Largely yes, because Vietnam, Thailand, Malaysia, the Philippines, and Indonesia all use the ASEAN Common Technical Dossier format. The technical modules covering quality, non-clinical, and clinical data are essentially shared. What changes between markets is Module 1 administrative content, country-specific labelling artwork, language translation requirements, and certain stability-zone declarations. Our regulatory team builds master ACTD files at the molecule level and then runs country-specific adaptations rather than rewriting from scratch each time, which is one of the structural reasons our ASEAN registration timelines are predictable.

From Mumbai Nhava Sheva to Cát Lái at the Ho Chi Minh City terminal we plan for fourteen to eighteen days of port-to-port transit on direct or single-transhipment services. Singapore and Port Klang are the common transhipment hubs. For Hai Phong serving the Hanoi region we typically plan sixteen to twenty days. We add three to four working days for Vietnamese customs clearance buffer, and our forwarders pre-file import documentation while the vessel is still at sea so the clock starts ticking before the container lands. Cold-chain biologics ship by air rather than sea.

Yes. Our regulatory desk includes Vietnamese-language consultants based in Ho Chi Minh City who handle notarised translation of administrative dossier sections, Vietnamese carton and inner-label artwork, package leaflets, and patient information leaflets where applicable. Translation is done before the dossier is submitted to DAV, and final artwork is regulatory-signed-off before printing plates are released to the manufacturing site. We do not treat Vietnamese translation as a buyer's responsibility, because rework on translation errors is one of the most common DAV registration delays and we would rather absorb that work upstream.

The ASEAN-India Free Trade Area agreement reduces or eliminates customs duty on most pharmaceutical tariff codes from Indian origin into Vietnam, provided the goods qualify for preferential origin status under the agreement's rules of origin. Our shipments include a Form AI Certificate of Origin issued by the Indian competent authority, which the Vietnamese importer presents at customs to claim the preferential rate. Eligibility depends on the specific HS code and the value-added rules, and our documentation team confirms qualification before each shipment rather than assuming the preference applies.

Yes, and we are direct about this. Commodity oral solid generics in high-volume therapy classes such as basic analgesics, simple antibiotics, and routine antihypertensives are well-served by Vietnamese domestic manufacturers including Imexpharm, DHG Pharma, and Pymepharco at price points where Indian sea-freight imports are not competitive. We focus our Vietnam offering on oncology, biologics, second-line anti-infectives, specialised injectables, and EU-GMP product where the regulatory positioning or therapy depth genuinely justifies import. Pretending otherwise would waste your time and ours.