How Brazilian Pharma Companies Can Source Quality CDMO & Pharmaceutical Products from India

India has become a global leader in pharmaceutical manufacturing and Contract Development and Manufacturing (CDMO) services. For Brazilian companies, sourcing medicines from India means gaining access to high-quality, affordable, and regulation-compliant pharmaceutical products.

With USFDA, WHO-GMP, and EU-approved facilities, Indian manufacturers deliver end-to-end solutions—from APIs to finished formulations—that meet Brazil’s strict ANVISA standards. Whether it’s importing pharmaceutical products from India or partnering with Indian CDMOs, the country offers unmatched quality, scale, and sreliability.

Why Brazilian Businesses Prefer India for Pharma Sourcing

Brazilian pharma companies increasingly choose India as a sourcing and CDMO partner because of its well-established manufacturing ecosystem and compliance record.

Key Advantages:

• Plants approved by USFDA, WHO-GMP, and EU regulators
• Competitive production and formulation costs
• Experienced in API development and innovation
• Consistent global audit history and quality systems
• Extensive portfolio covering generics, oncology, injectables, biosimilars, and wellness products

Most Demanded Pharma Categories in Brazil Sourced from India

Step-by-Step Process for Sourcing Pharma Products in India

1. Define Product & Regulatory Requirements

Identify the API or formulation, dosage form, and ensure compliance with ANVISA and Brazilian import regulations.

2. Shortlist Indian Manufacturers

Select audited, certified suppliers with WHO-GMP, EU-GMP, or USFDA approvals and proven export experience to Brazil.

3. Request Product Files & Certificates

Ask for product dossiers, Certificates of Analysis (COA), and past batch data to review quality performance.

4. Prepare Regulatory Submissions

Coordinate dossier preparation according to Brazilian CTD standards for ANVISA approval.

5. Verify Quality, Stability & Compliance

Ensure stability studies match Zone IVb (hot and humid) conditions required for Brazil.

6. Plan Logistics & Supply Chain

Align procurement, packaging, and shipping schedules for efficient delivery.

Paperwork & Documentation Required for Brazil Imports

To successfully import pharma products from India, the following documents are essential:

• Certificate of Pharmaceutical Product (COPP)
• GMP Certificate
• Certificate of Analysis (COA) / Batch Records
• Registration Dossier (CTD format)
• Free Sale Certificate (if applicable)
• Bill of Lading, MSDS, and Packing List

India–Brazil Logistics & Shipping Overview

• Sea Freight: 3–6 weeks (bulk or API shipments)
• Air Freight: 4–10 days (for smaller or urgent consignments)
• Cold Chain Services: Available for temperature-sensitive injectables and APIs
• Major Indian Ports: Mumbai, Mundra, Chennai

In Brazil

• Regulatory Authority: ANVISA (Agência Nacional de Vigilância Sanitária)
• Submission Format: CTD-compliant dossiers only
• Average Review Timeline: 6–12 months
• Stability Zone: IVb (30°C / 75% RH)

For Brazilian pharmaceutical companies, India remains the most dependable partner for sourcing APIs, formulations, injectables, and wellness products.
Indian manufacturers offer quality, affordability, and consistent regulatory compliance, backed by decades of export expertise.

Start your sourcing journey today — connect with trusted Indian pharma suppliers and CDMO partners to streamline your import and collaboration process.