How Companies in Myanmar Can Source Pharma Products & CDMO Services from India

Myanmar has a growing Pharmaceutical Market. It has increasing needs for essential medicines and the treatment of chronic diseases, antibiotics and hospital supplies as well as pediatric formulations. Myanmar imports many of its medicines because it lacks manufacturing capability and demand continues to increase. Of all the countries exporting pharmaceuticals and other products, India is Myanmar’s most trusted partner.

India is an affordable source of WHO-GMP products. India has competitive pricing, stable supply and extensive knowledge of Myanmar's regulatory environment through the Myanmar Food and Drug Administration (MFDA) /FDA. This will benefit Myanmar's distributors, importers, hospitals and procurement agencies in sourcing Pharmaceuticals and CDMO services from India compliantly and efficiently.

Why Myanmar Imports Pharmaceuticals From India

1. WHO-GMP Manufacturing & Global Certifications

India is home to advanced facilities certified under:

• WHO-GMP
• USFDA
• EU-GMP
• MHRA
• PIC/S

These align well with Myanmar FDA’s import and registration requirements.

2. Cost-Effective Medicines

In addition, India represents a significant price advantage, averaging 30-70% less than the prices of many global suppliers, which is important to Myanmar's cost-conscious public and private sector.

3. Wide Therapeutic Coverage

India supplies all major therapeutic categories needed in Myanmar:

• Antibiotics and anti-infectives
• Antimalarials
• GI medicines
• Pain & fever
• Diabetes & hypertension
• Pediatric formulations
• Injectables
• Nutraceuticals
• Oncology (selected injectables)

4. Strong API & Formulation Capabilities

Myanmar’s limited API production makes India a critical supplier of raw materials.

5. Experience With MFDA Registration

Indian exporters understand:

• Dossier preparation
• Stability data
• Import permit processes
• Labeling rules
• Sample submissions

6. Dependable Supply Chain

India supports Myanmar with consistent supply, even during market disruptions or demand spikes.

What Myanmar Commonly Sources From India

1. Essential Medicines

These include:

• Antimalarials
• Antibiotics
• Antipyretics
• Antihistamines
• GI therapies

2. Chronic Disease Medicines

High-demand categories:

• Diabetes
• Hypertension
• Lipid management
• Cardiovascular therapies

3. APIs

For local formulation and compounding:

• Paracetamol
• Metformin
• Diclofenac
• Omeprazole
• Cefuroxime
• Azithromycin

4. Injectables

India supplies:

• IV antibiotics
• Oncology vials
• Small-volume parenterals
• IV fluids
• Lyophilized injectables

5. OTC & Nutraceutical Products

Including:

• Vitamins
• Herbal supplements
• Immunity boosters
• Energy supplements

6. Medical & Hospital Supplies

• Syringes
• IV sets
• Gloves
• Masks
• Surgical consumables

Step-by-Step: How Myanmar Companies Can Source From India

Step 1: Create a clear sourcing requirement

List:

• Molecule
• Strength
• Dosage form
• Pack size
• Required quantity
• Whether product needs registration

Step 2: Shortlist verified Indian manufacturers

Select WHO-GMP–certified companies with:

• Prior export to Myanmar
• Strong regulatory documentation
• Good audit history

Step 3: Request technical documentation

Ask for:

• COA
• GMP
• COPP
• Batch records
• Stability data
• CTD/ACTD dossier

Step 4: MFDA Registration

Myanmar FDA requires:

• Full dossier submission
• Samples
• Stability data (Zone IV)
• Artwork in English/Burmese (if required)

Step 5: Finalize commercial terms

Discuss:

• MOQ
• Price (FOB/CIF)
• Payment terms
• Packaging
• Lead times
• Private label requirements

Step 6: Plan logistics & customs clearance

Choose air or sea based on urgency and cost.

Logistics From India to Myanmar

Myanmar has excellent connectivity to India due to geographical proximity.

Major Export Ports in India

• Kolkata Port
• Chennai Port
• Vishakhapatnam Port
• Mumbai (JNPT)
• Hyderabad & Delhi airports

Transit Times

Air Freight:

• 2–5 days (Kolkata/Hyderabad → Yangon)
• Ideal for APIs, injectables, urgent orders

Sea Freight:

• 7–15 days (Chennai/Kolkata → Yangon)
• Very economical for bulk imports

Legal & Regulatory Overview (Myanmar – FDA Myanmar)

Pharmaceutical imports into Myanmar must comply with MFDA (Myanmar Food and Drug Administration).

1. Product Registration Requirements

MFDA registration includes:

• CTD/ACTD dossier
• GMP certificate
• COPP
• Stability data
• Batch MFR
• Samples for testing
• Packaging material details

2. Local Agent Requirement

Myanmar requires a local agent or importer who handles:

• Registration
• Pharmacovigilance
• Complaints
• Renewal

3. Labeling Rules

Labels must include:

• Batch number
• Manufacturing & expiry date
• Storage conditions
• Manufacturer details
• English/Burmese text (depending on product)

4. Renewal & Variations

Products must be renewed every 3–5 years.
Variations require separate filings.

5. Indian Supplier Support

Most Indian exporters offer:

• Dossier submission support
• Stability data
• Regulatory clarifications
• Artwork templates

India has mechanisms that are powerful to resolve such problems.

In Summary, India is Myanmar's most reliable, cost-effective Partner for Pharmaceuticals. With WHO-GMP quality, competitive pricing, extensive product availability, and substantial MFDA registration support, Indian manufacturers are providing Myanmar's Healthcare Sector with consistent and compliant access to essential medicines, APIs, injectables and OTC products. For Hospitals, Pharmacies, NGOs, or National Tenders, partnering with India presents a long-term, stable, and regulatory-friendly supply chain model.

❓ Frequently Asked Questions (FAQs)

1. Can Myanmar companies import medicines directly from India?

Yes. India is Myanmar’s largest supplier of pharmaceuticals.

2. Do Indian manufacturers support MFDA registration?

Yes. Most Indian exporters have MFDA-ready dossiers and stability data.

3. How long does shipping take?

• Air: 2–5 days

• Sea: 7–15 days

4. What are typical MOQs?

• Tablets: 100k–300k units

• Injectables: 5k–20k vials

• APIs: 25–100 kg

5. Are labels required in Burmese?

Some therapeutic categories require Burmese labels; others accept English.

6. Can Indian CDMOs supply private-label products for Myanmar?

Yes — for OTC, herbal, nutraceuticals, and selected pharmaceuticals.

7. What documents are needed for import?

COA, GMP, COPP, COO, invoice, packing list, BL/AWB, stability data, dossier.

8. Are Indian medicines accepted in Myanmar tenders?

Yes. Many tender-winning medicines in Myanmar come from India.