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

With the growing demand for medicines to treat chronic illnesses, as well as OTCs and medical supplies, the Philippines's pharmaceutical market is among the fastest-growing in Southeast Asia. An increasing number of Filipino companies are now looking to purchase pharmaceutical products (APIs) and contract manufacturing services (CDMO and generic) from other countries because of their inability to obtain high-quality products from local manufacturers. The most significant source of pharmaceutical products for the Philippines will continue to be India.

Indian manufacturers provide very competitive pricing for pharmaceuticals and APIs while following WHO-GMP and USFDA compliance from facilities based in India. Additionally, Indian manufacturers have extensive knowledge and experience in working with the FDA in the Philippines concerning product registrations. This guide outlines how companies located in the Philippines can efficiently and safely procure pharmaceutical products (APIs) and injectables from India while remaining compliant with all applicable regulations within the Philippines.

Why Filipino Buyers Choose India for Pharmaceutical Sourcing

1. Strong WHO-GMP and Global Compliance

India is home to hundreds of WHO-GMP–approved and globally certified plants, including:

• WHO-GMP
• USFDA
• EU-GMP
• MHRA
• TGA

This ensures quality that aligns with FDA Philippines expectations.

2. Affordable and Transparent Pricing

India offers 30–60% lower pricing for many medicine categories, helping companies stay competitive in both retail and tender markets.

3. Broad Product Availability

India supplies nearly all pharmaceutical categories needed in the Philippines:

• Diabetes & hypertension
• Gastrointestinal
• Anti-infectives
• Pain & fever
• Pediatric medicines
• Nutraceuticals
• Injectables
• APIs for local production

4. Experience With FDA Philippines Registration

Indian exporters regularly provide support for:

• CTD dossiers
• Stability data (Zone IVB)
• Labeling requirements
• Product samples
• Foreign GMP documentation

5. Reliable Supply Infrastructure

India’s capacity ensures consistent supply for high-demand therapeutic categories.

What the Philippines Commonly Imports From India

1. Finished Pharmaceutical Formulations

India exports:

• Tablets
• Capsules
• Syrups & suspensions
• Powders & sachets
• Ointments
• Soft gels

Therapeutic categories include:

• Anti-infectives
• Cardiovascular
• Diabetes
• Gastrointestinal
• Antihistamines
• Vitamins

2. APIs for Local Manufacturing

Indian API exporters supply:

• Paracetamol
• Metformin
• Omeprazole
• Losartan
• Amoxicillin
• Cefuroxime
• Diclofenac

3. Injectable Products

India supplies:

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

4. OTC, Herbal & Nutraceuticals

Popular imports include:

• Vitamins & minerals
• Herbal supplements
• Immunity products
• Lifestyle supplements

5. Hospital & Medical Consumables

India supplies:

• Syringes
• IV sets
• Gloves
• Masks
• Cannulas
• Surgical disposables

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

Step 1: Prepare a detailed sourcing list

Include:

• Product name
• Dosage form
• Pack size
• Strength
• Annual volume
• Registration status

Step 2: Shortlist WHO-GMP Indian manufacturers

Choose suppliers with:

• FDA Philippines experience
• Proper regulatory documentation
• Strong audit and compliance history

Step 3: Request technical documentation

Key documents:

• COA
• GMP
• COPP
• Stability data
• Batch manufacturing record
• CTD dossier

Step 4: FDA Philippines Registration

Philippine registration requires:

• CTD format
• Stability zone IVB data
• Artwork in English
• Samples
• GMP clearance

For APIs:

• DMF / dossier
• Impurity profile
• COA

Step 5: Agree on commercial terms

Discuss:

• Pricing
• MOQ
• Packaging
• Delivery schedule
• Payment terms (TT/LC)

Step 6: Plan logistics and customs clearance

Select between air or sea based on urgency and cost.

Logistics From India to the Philippines

India and the Philippines have strong shipping connectivity via air and sea.

Major Export Ports

• Nhava Sheva (Mumbai)
• Mundra
• Chennai
• Hyderabad airport (ideal for APIs & injectables)
• Delhi airport

Transit Times

Air Freight:

• 3–6 days (Mumbai → Manila)
• Ideal for injectables, APIs, high-value shipments

Sea Freight:

• 12–20 days (Nhava Sheva → Manila, Cebu, Davao)
• Best for tablets, capsules, syrups, OTC products

Legal & Regulatory Overview (Philippines – FDA Philippines)

All pharmaceutical imports into the Philippines must meet the standards set by FDA Philippines.

1. Product Registration Requirements

◾ CTD dossier
◾ GMP certificate
◾ COPP
◾ Stability data (zone IVB)
◾ API documentation
◾ Product samples

2. Marketing Authorization Holder (MAH)

A local MAH is required for:

• Registration
• Pharmacovigilance
• Post-market surveillance

Most distributors or local partners serve as MAH.

3. Labeling Requirements

Labeling must include:

• English text
• Batch number
• Mfg/Exp dates
• Storage conditions
• Indications
• Registration number

4. Stability Requirements

Philippines uses Zone IVB climate guidelines.

5. Renewal & Variations

Products must be renewed every 3–5 years.
Any change in API source, packaging, or formulation requires variation approval.

6. Indian Supplier Support

Most Indian suppliers provide:

• Dossiers
• Stability studies
• COA/COC documents
• Artwork templates for FDA approval

✅ Best Practices for Filipino 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 serves as a major source for the pharmaceutical industry in the Philippines. Indian manufacturers provide the quality and reliability of the pharmaceutical products required by Filipino companies because of their competitive pricing, compliance with WHO-GMP and USFDA standards, and an extensive understanding of FDA requirements in the Philippines.

In summary, Indian manufacturers provide high-quality pharmaceutical products at a competitive price; they comply with all applicable regulations in the Philippines regarding product registration and labeling; and they provide their Filipino customers with the regulatory guidance required to remain compliant.

❓ Frequently Asked Questions (FAQs)

1. Can Filipino companies import medicines directly from India?

Yes. Many Philippine distributors and MAHs import directly from India.

2. Do Indian suppliers provide FDA Philippines documentation?

Yes — they provide CTD dossiers, stability data, GMP, and COPP.

3. How long does shipping take?

• Air: 3–6 days
• Sea: 12–20 days

4. Are labels required in English?

Yes. English is mandatory for pharmaceutical labels in the Philippines.

5. What are typical MOQs?

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

6. Can Indian CDMOs supply private label or OEM products?

Yes — many offer private label manufacturing for OTC, nutraceuticals, and pharmaceuticals.

7. What documents are needed for import?

Invoice, packing list, COA, COPP, GMP certificate, COO, BL/AWB.

8. Are Indian products accepted in Philippine tenders?

Yes. Many tender-winning products originate from India.