Pharmaceutical Manufacturer in India for Importers in Myanmar
Your brand, made at our own WHO-GMP plant in Panchkula, with the FDA Myanmar registration held in your name
Myanmar imports about 80 per cent of its pharmaceutical products, and India is the main supplier, according to the US International Trade Administration. The importers who do well are the ones whose Indian source answers FDA Myanmar’s questions, stands up to a site inspection and ships the same quality on the tenth order as on the first. That is the job we do.
- Our own plant, not a trading house. One WHO-GMP site for tablets, capsules and oral liquids, with GLP laboratories in the next block. FDA Myanmar queries are answered by the people who made the batch.
- Artwork and foil printed in-house. Your blister foil and cartons are printed on our own rotogravure unit, so a FDA Myanmar label change or a re-order never waits on a converter.
- One container, your whole range. Tablets, capsules, oral liquids and creams from one gate, with 39 products already approved for export to USP and BP monographs.
Start here
Send us four things and you get feasibility, rate, batch size and lead time in writing.
- Products and strengths you want to register
- Pack sizes and annual quantity
- FDA Myanmar’s document requirement list
- Your artwork, or ask us to prepare it
WhatsApp the export desk
Email info.vh@vibcare.co.in
Request samples
Or call +91 85660 76607
Why importers in Myanmar work with Vibcare Healthcare
What is different when the manufacturer owns the plant
FDA Myanmar-ready from the site
Site certificates, product specifications, batch records, certificates of analysis and stability data come from one quality unit, on FDA Myanmar’s checklist, in the order the assessor asks for them. The plant is open to FDA Myanmar inspection by appointment.
Documentation that survives an audit
Every batch ships with its certificate of analysis and batch manufacturing record. Written specifications, validated methods and ICH stability data from our own chambers, run at the conditions Myanmar’s climatic zone requires.
Your brand, your artwork, our press
English and Myanmar packs with the FDA Myanmar registration number, batch and expiry printed to your approved artwork; blister and strip foil printed inside the plant on a 4-colour rotogravure unit. Label changes stay on our schedule.
A range, not a product
Anti-infectives, cardiovascular, gastro-intestinal, pain and anti-allergic products from the export list, plus anything from 750-plus approved formulations added against your order, consolidated into one consignment to Yangon.
From Panchkula to Yangon (Thilawa)
Road to Nhava Sheva, sea via the Bay of Bengal and Singapore; air freight to Yangon International Airport
What is already in place
Numbers an importer can check
How FDA Myanmar registration runs with us
You apply; the manufacturer’s part comes from Dabkori
What arrives from Dabkori for your FDA Myanmar file
- Notarised power of attorney naming your company as applicant
- WHO-GMP site certificate, GMP (Revised Schedule M) and GLP certificates
- Manufacturing licences MLF252023HR000004 and MLF282023HR000005
- Product specifications and methods of analysis, finished product and raw material
- Batch manufacturing and packing records, with certificates of analysis
- Stability data from ICH accelerated and long-term studies in our own chambers
- Samples of each product for FDA Myanmar laboratory analysis where required
- Label, leaflet and carton artwork proofs in English and Myanmar, with the registration number and batch details
- Answers to assessor queries, and the plant open for FDA Myanmar site inspection
- Further items on FDA Myanmar’s checklist as they are asked for
- You send the requirement. Products, packs, quantity and FDA Myanmar’s document list. Confidentiality agreement signed first if you want one.
- We answer in writing. Feasibility against the export list and licence, rate, batch size, lead time, and a notarised power of attorney naming your company as applicant.
- Dossier and samples. Applications are submitted by an authorised representative resident in Myanmar, the local importer or product licence holder, holding the manufacturer's letter of authorisation. Manufacturer’s documents are supplied in FDA Myanmar’s format (ASEAN Common Technical Dossier (ACTD), in English), samples shipped where required, assessor queries answered from the site.
- First consignment. Artwork approved, batches manufactured and released against specification, and shipped with certificate of analysis and batch documents. Sea freight to Yangon via Singapore transhipment. About one year for established medicines and 18 months or more for products new to Myanmar (FDA guideline). Registration validity: 5 years, per consultancy sources; renewal is applied for 90 days before expiry.
The plant behind your brand
Four sections at Dabkori, Panchkula, commissioned in 2023
Tablets — 1.1 billion a year
Two Saral granulation lines, 27- and 37-station Karnavati presses, 48-inch Gansons auto-coater; uncoated, film-coated, enteric, sustained-release, dispersible and bilayer tablets. 334 formulations on the product list.
Capsules — 950 million a year
ACG AF90T automatic filling with a Captech semi-automatic line; powder, pellet and pellet-plus-powder fills, enteric PPI and sustained-release pellets. 69 formulations on the product list.
Oral liquids — 30 million bottles a year
NPM 3 kL manufacturing plant and 6-head filling line; syrups, suspensions, solutions and oral drops in HDPE, PET and glass. 85 formulations on the product list.
Creams, ointments and gels — 40 million tubes a year
NPM manufacturing plant and Pacmac tube filler; creams, ointments, gels, lotions and topical solutions in laminate and aluminium tubes. 108 formulations on the product list.
Plant infrastructure
What a FDA Myanmar inspector sees on site
WHO-GMP site certificate
GMP — Revised Schedule M
GLP certificate
ISO 9001:2015All 39 export approvals
On the Indian licence, written to USP and BP monographs
Any other product from the 750-plus approved formulations is added to the export list against your order, with the export approval applied for from FDA Haryana and stability set down for Myanmar’s climatic zone.
Questions importers in Myanmar ask
Before you send a requirement
Who applies to FDA Myanmar, you or us?
You do. Applications are submitted by an authorised representative resident in Myanmar, the local importer or product licence holder, holding the manufacturer's letter of authorisation. We give you a notarised power of attorney, every manufacturer's document on FDA Myanmar's checklist, samples for laboratory analysis and answers to assessor queries from the site.
Will FDA Myanmar inspect your plant?
Regulators may inspect foreign manufacturing sites as part of registration. Ours is a WHO-GMP certified plant commissioned in 2023, with GLP laboratories on site, and it is open to FDA Myanmar and to you by appointment.
How long until my product is registered and shipped?
About one year for established medicines and 18 months or more for products new to Myanmar (FDA guideline). Registration validity: 5 years, per consultancy sources; renewal is applied for 90 days before expiry. The manufacturing lead time for your first consignment comes with the proposal, in writing.
Which language do you print the packs in?
English and Myanmar, to the artwork you approve, with blister and strip foil printed inside our plant. Dossier documents are supplied in the format FDA Myanmar uses: ASEAN Common Technical Dossier (ACTD), in English.
What is the minimum order?
It follows the batch size of each product. Because tablets, capsules and oral liquids come from one site, a first consignment is usually consolidated across products rather than filled with one.
Which products can you supply straight away?
39 products already approved for export to USP and BP monographs, across anti-infectives, cardiovascular, gastro-intestinal, pain and anti-allergic classes. Anything else on our 750-plus approved formulations is added to the export list against your order.
Send your Myanmar requirement today
Products, pack sizes, annual quantity and FDA Myanmar’s document list. You will get feasibility, rate, batch size and lead time in writing.
info.vh@vibcare.co.in · +91 85660 76607 · Khasra 6/2/2, Kot Road, Village Dabkori, Panchkula, Haryana 134103 · Other markets in Asia
