Pharmaceutical Manufacturer in India for Bhutanese Importers
Your brand, made at our own WHO-GMP plant in Panchkula, with the BFDA registration held in your name
Bhutan imported about US$6.5 million of pharmaceutical products from India in 2025, according to UN Comtrade data. The importers who do well are the ones whose Indian source answers BFDA’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. BFDA 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 BFDA 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
- BFDA’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 Bhutanese importers work with Vibcare Healthcare
What is different when the manufacturer owns the plant
BFDA-ready from the site
Site certificates, product specifications, batch records, certificates of analysis and stability data come from one quality unit, on BFDA’s checklist, in the order the assessor asks for them. The plant is open to BFDA 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 Bhutan’s climatic zone requires.
Your brand, your artwork, our press
English packs with the BFDA 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 Thimphu.
From Panchkula to Phuentsholing
Road from Panchkula through Siliguri to Phuentsholing; air freight to Paro International Airport
What is already in place
Numbers an importer can check
How BFDA registration runs with us
You apply; the manufacturer’s part comes from Dabkori
What arrives from Dabkori for your BFDA 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 BFDA laboratory analysis where required
- Label, leaflet and carton artwork proofs in English, with the registration number and batch details
- Answers to assessor queries, and the plant open for BFDA site inspection
- Further items on BFDA’s checklist as they are asked for
- You send the requirement. Products, packs, quantity and BFDA’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. Under Rule 120 of the Bhutan Medicines Rules and Regulation 2019, a manufacturer inside or outside Bhutan, or a licensed local dealer holding a BFDA technical authorisation, may apply for product registration. Manufacturer’s documents are supplied in BFDA’s format (ASEAN Common Technical Dossier (ACTD) format prescribed by the BFDA, 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. Road freight from Panchkula through Siliguri and the Jaigaon–Phuentsholing border. Rule 136 requires the certificate within 60 days of complete documents; the BFDA FAQ says two to three months. Registration validity: 3 years (Rule 138).
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 BFDA 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 Bhutan’s climatic zone.
Questions Bhutanese importers ask
Before you send a requirement
Who applies to BFDA, you or us?
You do. Under Rule 120 of the Bhutan Medicines Rules and Regulation 2019, a manufacturer inside or outside Bhutan, or a licensed local dealer holding a BFDA technical authorisation, may apply for product registration. We give you a notarised power of attorney, every manufacturer's document on BFDA's checklist, samples for laboratory analysis and answers to assessor queries from the site.
Will BFDA 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 BFDA and to you by appointment.
How long until my product is registered and shipped?
Rule 136 requires the certificate within 60 days of complete documents; the BFDA FAQ says two to three months. Registration validity: 3 years (Rule 138). The manufacturing lead time for your first consignment comes with the proposal, in writing.
Which language do you print the packs in?
English, to the artwork you approve, with blister and strip foil printed inside our plant. Dossier documents are supplied in the format BFDA uses: ASEAN Common Technical Dossier (ACTD) format prescribed by the BFDA, 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 Bhutan requirement today
Products, pack sizes, annual quantity and BFDA’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
