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

Thailand has developed into one of the leading and best organized pharmaceutical sectors in Southeast Asia due to its strong healthcare system, an increasing number of patients requiring medicines to treat chronic illnesses, and the growing interest in cost-effective imports. As a result, Thailand imports a substantial amount of its pharmaceutical supply from other countries, including India.

India has established itself as a significant supplier of active pharmaceutical ingredients (APIs) and finished dosage forms (FDs) for approved markets. Many manufacturers in Thailand partner with Indian suppliers in order to reduce their costs, establish reliable and consistent supplies, and take advantage of WHO-GMP, USFDA, and EU-GMP quality standards that align with the requirements of the Thai FDA. This guide contains information to assist Thai manufacturers in identifying sources for pharmaceuticals and contract development and manufacturing organizations (CDMOs) based in India, and how to do this in a safe, legally compliant, and efficient manner.

Why Thai Companies Source Pharmaceuticals From India

1. High Quality and International Certification

India has one of the world’s largest numbers of:

• WHO-GMP plants
• USFDA-approved facilities
• EU-GMP facilities
• PIC/S-compliant manufacturers

This gives Thai buyers confidence in quality and regulatory compliance.

2. Significant Cost Advantage

India offers 30–50% lower manufacturing costs for:

• APIs
• Oral solids
• Injectables
• Specialty medicines

This helps Thai companies remain competitive in public and private procurement.

3. Strong API Manufacturing Base

Thailand imports many APIs from India, including:

• Metformin
• Paracetamol
• Cefuroxime
• Diclofenac
• Pantoprazole
• Atorvastatin
• Azithromycin

Indian API exporters offer DMF support, stability data, and regulatory documentation needed for Thai registration.

4. Experience With Thai FDA Regulatory Requirements

Indian exporters understand:

• ACTD/eCTD dossier format
• Stability data (Zone IVB)
• Thai labeling rules
• Lab sample submissions
• GMP clearance processes

5. Broad Product Portfolio

India supplies nearly all therapeutic categories needed in Thailand:

• Diabetes
• Hypertension
• GI
• Antibiotics
• Pain & fever
• Oncology
• Pediatric products
• Nutraceuticals

6. Reliable Supply Chain

India’s manufacturing capacity ensures stable supply even during disruptions.

What Thailand Commonly Sources From India

1. APIs

High-demand APIs include:

• Ibuprofen
• Metformin
• Atorvastatin
• Cefixime
• Ciprofloxacin
• Pantoprazole
• Paracetamol

These support Thailand’s local formulation industry.

2. Finished Pharmaceutical Products

India supplies:

• Tablets & capsules
• Oral liquids
• Sachets & powders
• Ointments
• Soft gels

Therapeutic areas:

• Anti-infectives
• Cardiovascular
• Diabetes
• Gastrointestinal
• Respiratory
• Dermatology

3. Injectables

Including:

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

4. OTC & Nutraceutical Products

Thailand imports:

• Vitamins
• Herbal & Ayurvedic products
• Immunity supplements
• Joint health supplements

5. Medical Supplies

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

6. CDMO & OEM Manufacturing

Indian CDMOs support:

• Private-label medicines
• Nutraceutical manufacturing
• Custom formulation development
• Packaging & branding

Step-by-Step: How Thai Companies Can Source Pharmaceuticals From India

Step 1: Prepare a detailed sourcing list

Include:

• Product name
• Dosage form/strength
• Pack size
• Annual consumption
• Registration requirement
• API or finished product

Step 2: Shortlist WHO-GMP/EU-GMP Indian Manufacturers

Choose suppliers with:

• Thai FDA experience
• Strong regulatory documentation
• Good audit history

Step 3: Request technical documents

Ask for:

• COA
• GMP
• DMF (APIs)
• CTD/ACTD dossier
• Stability data (Zone IVB)
• Batch MFR

Step 4: Thai FDA Registration

Thailand’s registration process requires:

• ACTD/eCTD dossier
• GMP inspection or certificates
• Samples
• Stability data
• Local representative (MAH)

Step 5: Finalize commercial terms

Discuss:

• Pricing
• MOQ
• Packaging
• Payment terms
• Delivery schedules
• Brand vs. private label

Step 6: Plan logistics & customs clearance

Select between economical sea freight or fast air freight.

Logistics From India to Thailand

Due to geographical proximity, India–Thailand logistics are fast and efficient.

Major Indian Export Hubs

• Mumbai (Nhava Sheva)
• Chennai
• Kolkata
• Hyderabad airport
• Delhi airport

Transit Times

Air Freight:

• 2–4 days (Mumbai/Chennai → Bangkok)
• Ideal for urgent orders, APIs, injectables

Legal & Regulatory Overview (Thailand – Thai FDA)

Thailand’s pharmaceutical imports are regulated by the Thai Food and Drug Administration (Thai FDA).

1. ACTD / eCTD Dossier Requirements

Thai FDA typically requires:

• ACTD/CTD dossier
• GMP certificate
• API documentation
• Stability data
• Product samples
• Packaging details
• Safety/efficacy information

2. Local Marketing Authorization Holder (MAH)

A local MAH is mandatory for:

• Registration
• Pharmacovigilance
• Complaints handling
• Post-approval variations

3. Labeling Requirements

Thailand requires:

• Thai language labeling
• English + Thai for leaflets
• Storage conditions
• Batch details
• Registration number

4. Renewal & Variations

Products must be renewed every 3–5 years.
Changes in API source, packaging, or artwork require variation approval.

5. Indian Supplier Support

Most Indian exporters to Thailand provide:

• ACTD dossiers
• Stability studies
• DMFs
• Packaging templates
• Validation documents

India has mechanisms that are powerful to resolve such problems.

As a pharmaceutical sourcing partner for Thailand, India provides quality pharmaceutical products that meet USFDA and EU-GMP standards at competitive prices, with a vast selection of products, and alignment of its regulatory requirements with the requirements of the Thai FDA. Consequently, Thai pharmaceutical manufacturers can rely on and have confidence in the long-term stability and reliability of their supplies from India, regardless of whether they are purchasing APIs, generic products, injectables, OTCs, or private-label products.

❓ Frequnetly Asked Questions (FAQs)

1. Can Thailand import medicines directly from India?

Yes. India is a major supplier to Thailand for APIs, generics, and injectables.

2. Do Indian suppliers support Thai FDA registration?

Yes — many provide ACTD/eCTD dossiers, stability data, GMP, and DMF.

3. What are typical shipping times?

• Air: 2–4 days
• Sea: 7–12 days

4. Are Thai-language labels required?

Yes. Thai FDA requires Thai language on packaging and leaflets.

5. What are typical MOQs?

• Tablets: 100k–300k units
• Injectables: 5k–20k vials
• APIs: 25–100 kg

6. Can Indian CDMOs support OEM/private label for Thailand?

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

7. What documents are required for import?

COA, GMP, DMF, COO, invoice, packing list, BL/AWB, dossier.

8. Are Indian APIs accepted in Thailand’s local manufacturing?

Yes — provided the API manufacturer meets Thai FDA or PIC/S GMP standards.