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

Indonesia is considered the largest pharmaceutical market within Southeast Asia, with nearly 270 million residents, an increasing demand for chronic disease therapies, and an expanding healthcare system that needs a constant supply of quality, affordable medicines.

India is one of Indonesia's most significant pharmaceutical partners for APIs, final formulations, injectables, medical supplies for hospitals (i.e., injection supplies), and services from Contract Development and Manufacturing Organizations (CDMOs). The Indian pharmaceutical industry can supply APIs to Indonesian manufacturers for a very competitive price, with the reliability and experience to achieve compliance with WHO-GMP standards and Good Manufacturing Practices established by the FDA (Food and Drug Administration) and EU.

This guide provides details on how Indonesian businesses can purchase medicines and contract manufacturing services from India with maximum efficiency, safety, and compliance with local laws and regulations.

Why Indonesian Companies Choose India for Pharma Sourcing

1. Large API Manufacturing Base

Indonesia relies heavily on APIs from India for local production. India supplies:

• Antibiotic APIs
• Antidiabetic APIs
• GI APIs
• Pain relief APIs
• Cardiovascular APIs

Indian API manufacturers support:

• DMF submissions
• stability data
• impurity profiles
• batch documentation

2. Competitive Pricing

India offers 30–50% lower cost for APIs and formulations compared to many global suppliers. This supports Indonesia’s competitive retail and tender markets.

3. WHO-GMP, USFDA, and EU-GMP Quality

Many Indian manufacturing facilities hold:

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

This aligns well with BPOM expectations.

4. Experience With BPOM Registration

Indian exporters understand:

• CTD dossier templates
• Stability zone IV requirements
• Lab sample submission
• Indonesian labeling rules

5. Broad Product Range

India supplies nearly all therapeutic classes needed in Indonesia:

• Diabetes
• Hypertension
• GI
• Antibiotics
• Pediatric medicines
• Nutraceuticals
• OTC products
• Injectable antibiotics
• Oncology (selected)

What Indonesia Commonly Sources From India

1. APIs (Highest Volume Import)

Top APIs imported from India include:

• Paracetamol
• Metformin
• Omeprazole
• Diclofenac
• Amoxicillin / Clavulanic acid
• Cefuroxime
• Atorvastatin

These support Indonesia’s strong local manufacturing sector.

2. Finished Formulations

Indian suppliers export:

• Tablets
• Capsules
• Powders
• Syrups
• Sachets
• Soft gels

3. Injectables

• Cephalosporin injectables
• Oncology vials
• Lyophilized injections
• Small volume parenterals (SVP)
• IV fluids

4. OTC, Herbal & Nutraceuticals

Indonesia has strong demand for:

• Vitamins
• Immunity boosters
• Traditional/herbal formulations
• Energy supplements

5. Medical Consumables

• Syringes
• IV sets
• Infusion sets
• Disposable gloves

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

Step 1: Prepare a clear sourcing list

Include:

• Molecule
• Strength
• Dosage form
• Quantity
• Registration requirement

Step 2: Shortlist WHO-GMP or EU-GMP Indian manufacturers

Prefer companies with:

• BPOM experience
• Existing Indonesian registrations
• Strong regulatory teams

Step 3: Request regulatory documents

Key files include:

• COA
• GMP certificate
• DMF (for APIs)
• CTD dossier
• Stability data (zone IVB)
• Batch MFR documents

Step 4: BPOM Registration

Finished formulations require:

• Full CTD dossier
• Artwork in Bahasa Indonesia
• Samples for testing
• Stability data

APIs require:

• DMF
• COS/CEP (if available)
• COA & impurity profile

Step 5: Finalize pricing & terms

Discuss:

• MOQ
• Packaging
• Branding (if private label)
• Lead time
• Payment terms (LC/TT)

Step 6: Plan logistics & clearances

Choose between air and sea depending on urgency and volume.

Logistics From India to Indonesia

India and Indonesia have strong shipping connections via air and sea.

Major Export Ports

• Mumbai (Nhava Sheva / JNPT)
• Mundra
• Chennai
• Hyderabad airport
• Delhi airport

Transit Times

Air Freight:

• 3–6 days (Mumbai → Jakarta)
• Ideal for APIs, injectables, urgent orders

Sea Freight:

• 12–22 days (Nhava Sheva → Jakarta / Surabaya)
• Suitable for high-volume products

Legal & Regulatory Overview (Indonesia – BPOM)

Pharmaceutical imports into Indonesia are regulated by BPOM (National Agency for Drug and Food Control).

1. Product Registration Requirements

BPOM typically requires:

• CTD dossier
• GMP certificate
• COPP
• Stability data (zone IVB)
• Sample submission
• Label & artwork in Bahasa Indonesia

2. DMF & API Registration

API registration requires:

• DMF/ASMF
• Quality certificates
• Impurity profile
• Process validation documents

3. Local MAH Requirement

Indonesia requires a Marketing Authorization Holder based locally.
Some companies partner with:

• Local distributors
• Local manufacturers
• Local regulatory agents

4. Packaging & Label Rules

Artwork must include:

• Bahasa Indonesia text
• Storage conditions
• Batch details
• Approved BPOM registration number

5. Renewal & Variations

Any change in:

• API source
• Packaging
• Strength
• Requires variation filing.

6. Indian Supplier Support

Most Indian exporters provide:

• Ready dossiers
• Stability data
• Packaging templates
• Technical file updates

✅ Best Practices for Indonesian Buyers

• Verify EU-GMP status
• Request last audit report
• Review quality systems
• Run a small pilot batch
• Set clear timelines and SOPs
• Consider dual sourcing for risk control

These steps help ensure long-term, stable partnerships.

India is the most strategically important country for Indonesia to source pharmaceuticals. The combination of a reliable source for APIs, competitively priced medicines, WHO-GMP-certified quality, and significant BPOM experience, positions India as a reliable source of supply to support Indonesia's need for essential medicines, APIs, injectables, and over-the-counter products. Working with the right Indian partners ensures compliance, cost efficiency, and long-term reliability in one of Asia’s most demanding markets.

❓ FAQs

1. Can Indonesian companies import medicines directly from Indian manufacturers?

Yes. Many Indonesian companies import APIs and finished formulations from India.

2. Do Indian suppliers support BPOM registration?

Yes — most provide CTD dossiers, DMFs, and stability data.

3. How long does shipping take?

• Air: 3–6 days
• Sea: 12–22 days

4. What are typical MOQs?

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

5. Is Bahasa Indonesia labeling mandatory?

Yes — BPOM requires all pharmaceutical labels to be in Bahasa Indonesia.

6. Do Indian CDMOs provide private-label manufacturing?

Yes. Many support private-label, herbal, nutraceutical, and OTC product development for Indonesia.

7. Are Indian APIs accepted for Indonesian manufacturing?

Yes — India is the largest API supplier to Indonesia.

8. What documents are needed for import into Indonesia?

Invoice, packing list, COA, COO, DMF (for APIs), BL/AWB, GMP, stability data.