Sourcing Pharmaceutical Products & CDMO Services From India — Complete Guide for Latin America (APIs, Generics, Injectables & Contract Manufacturing)

Introduction

Latin America is continuously evolving and growing in the field of pharmaceuticals. Due to the increasing demand for affordable medicines, APIs, injectables, biosimilars, specialty formulations, and others, more hospitals, government tenders, distributors, pharmacy chains, and local manufacturers are seeking them.

While several Latin American countries have strong domestic pharmaceutical industries, many markets in the region continue to rely upon importation of APIs, intermediates, bulk drugs, finished formulations, medical consumables, and contract manufacturing services. As a result, India has become one of the principal global partners in the Latin American pharmaceutical supply chain.

India currently exports large quantities of generic medicines, APIs, oncology drugs, sterile injectables, nutraceuticals, and CDMO services to regulated and semi-regulated markets all over the world. As a result, many Latin American companies prefer to work with India due to its combination of:

• WHO-GMP, USFDA & EU-GMP compliant manufacturing
• Competitive pricing
• Ability to produce large volumes of products
• Awareness of the regulatory systems of Latin America
• Flexible business models including private-label & licensing
• Experience exporting to markets within Latin America

This guide serves as a regional reference hub for Latin American buyers, covering:

• Why companies in Latin America source pharmaceuticals from India
• Key product categories imported from India
• Regulatory & documentation landscape across LATAM
• Logistics routes, shipping costs & temperature-controlled handling
• Step-by-step sourcing & vendor selection process
• Common challenges & practical solutions
• Country-level differences & internal-link opportunities
• The role of India as a long-term CDMO & manufacturing partner

The goal is to help distributors, importers, marketing authorization holders (MAH), manufacturers, hospitals, tender agencies, and healthcare groups make informed, compliant, and strategic sourcing decisions.
 

Why Latin American Pharma Buyers Source From India
 

1. Strong Cost Advantage With Global-Standard Quality

India is able to provide 30 to 60 percent lower production costs for many types of pharmaceutical products compared to other countries, while also producing products that meet stringent international quality standards and good manufacturing practices as established by the World Health Organization (WHO). India’s lower production costs also serve as a major competitive advantage in price-sensitive public procurement and insurance-driven markets.

Indian manufacturers are able to supply product to some of the most highly regulated markets in the world, such as the United States, Europe, Japan, and the Gulf Cooperative Council (GCC), providing buyers from Latin America an assurance of:

• Consistency in manufacturing batches
• Proven processes
• Cleanroom practices
• Documentation & traceability
• pharmacovigilance support

This combination of cost efficiency and quality assurance is one of the primary reasons that companies in Latin America prefer to source their products from India.
 

2. Broad Product Availability Across All Key Therapeutic Areas

India also has the largest product offerings of any country in the world across all key therapeutic categories. As such, a diverse range of product categories are available to Latin American providers, including:

• APIs & intermediates for local formulation
• Finished generic formulations
• Antibiotics & anti-infectives
• Chronic disease medications
• Oncology & critical-care injectables
• Hormonal & dermatology products
• Pediatric & liquid formulations
• OTC & nutraceuticals
• Medical supplies & hospital consumables

By providing a comprehensive product range and being able to service procurement pipelines, manufacturing operations, and tender programs throughout Latin America, India is uniquely positioned to be a partner in the growth of the pharmaceutical markets in LATAM.
 

3. Strong Experience With Latin American Regulatory Systems

Indian exporters increasingly work with regulatory authorities across the region, including:

• ANVISA (Brazil)
• COFEPRIS (Mexico)
• INVIMA (Colombia)
• ANMAT (Argentina)
• ISP Chile
• DIGEMID (Peru)
• MSPAS Guatemala
• ARCSA Ecuador

Many Indian manufacturers already have approved dossiers, prior registrations, or active product portfolios in these markets. This shortens approval timelines and reduces compliance risk.
 

4. Flexible Sourcing & Collaboration Models

Latin American companies work with India through multiple models:

• Direct product import & distribution
• Local partner / MAH based import model
• API sourcing for local manufacturing
• Private-label / branded generics
• Long-term licensing contracts
• Full-service CDMO partnerships

This flexibility allows buyers to choose a sourcing strategy that fits:

• regulatory structure
• market positioning
• pricing strategy
• investment capacity
   

5. High-volume production and supply capabilities

India supports large-scale government procurement programs, insurance-based supplies, and nationwide distribution networks.

This is especially valuable in:

• public hospital supply programs
• national tender pipelines
• chronic-disease therapy continuity
• humanitarian & relief supply chains

For many Latin American buyers, India is not just a vendor — it is a strategic continuity partner.
 

Latin America's Imports from India (Most Common)

1. APIs & Intermediates

APIs and Intermediates make up a huge part of the pharmaceutical market in Latin America. Because of this high dependency, India is one of the largest global sources of APIs used to support the following types of formulations:

• oral solid formulations
• injectables
• semi-solid topicals
• liquid and suspension manufacturing

Some examples of commonly sourced APIs include:

• Metformin, Losartan and Atorvastatin
• Paracetamol, Diclofenac and Ibuprofen
• Omeprazole, Pantoprazole and Esomeprazole
• Amoxicillin, Azithromycin and Cefuroxime
• Oncology APIs (select facilities)

Additionally, Indian API suppliers provide the following documentation in support of regulatory submissions in Latin America:

• DMFs
• impurity profiles
• stability data
• process validation documents

2. Finished Pharmaceutical Formulations

The Indian pharmaceutical manufacturing industry exports all of the following products to the Latin American market:

• tablets
• capsules
• syrups and suspensions
• powders and sachets
• soft gels
• ointments and creams

Therapeutic segments most affected by Indian pharmaceutical finished formulation exports include:

• cardiovascular and metabolic care
• gastrointestinal disorders
• pain and inflammation
• respiratory care
• antibiotics
• pediatrics
   

3. Sterile Injectables & Specialty Products

The Indian pharmaceutical manufacturing sector is a major provider of:

• IV antibiotics
• oncology injectables
• lyophilized injections
• small-volume parenterals
• anesthetic injectables
• electrolyte solutions & IV fluids

It is due to the cost competitiveness and verified sterilisation standards that many Latin American distributors are ordering these products from India.
 

4. Nutraceuticals, Herbal & OTC Products

There are many new categories emerging in India as well such as:

• vitamins & minerals supplements
• immunity supplements
• herbal & Ayurvedic products
• wellness capsules & powders
• sports nutrition

These categories are rapidly expanding in the Retail Markets of LATAM.
 

5. Medical Consumables & Hospital Supplies

The Indian Manufacturers are major suppliers of Medical Consumables and Hospital Supplies as follows:

• syringes & IV sets
• gloves, masks & bandages
• catheters & cannulas
• basic diagnostic consumables

All of these products support the Hospital, Clinic and Procurement Areas of Latin America.
 

Regulatory Environment Across Latin America

The Regulatory Framework for Latin America and the Caribbean varies substantially from country to country. However, many markets follow formats similar to:

• CTD/eCTD dossier structures
• WHO-GMP recognition
• stability zone III / IV requirements
• bioequivalence (where applicable)

In general, Indian suppliers who are familiar with LATAM Markets typically provide the following to their customers:

• GMP certificates
• COPP / Free Sale Certificate
• COA & batch documents
• stability reports
• samples when required
• validated manufacturing process files

Additionally, for some countries, regulatory approval may be obtained more quickly for products that are already registered in the comparable countries, which many Indian Suppliers can provide.
 

Logistics From India to Latin America

Shipping Modes

• Air freight: 4–10 days (commonly used for injectables & high-value APIs)
• Sea freight: 25–55 days depending on region & route

Major Indian Export Hubs

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

Key Latin American Entry Ports

• Santos (Brazil)
• Veracruz & Manzanillo (Mexico)
• Cartagena (Colombia)
• Buenos Aires (Argentina)
• Callao (Peru)
• Valparaíso (Chile)

Cold-Chain & Controlled Temperature Support

Indian exporters provide:

• 2–8°C cold chain
• frozen -20°C shipping
• 15–25°C controlled ambient
• temperature-logger documentation

This is essential for:

• injectables
• hormones
• insulin
• biologic temperature-sensitive products
   

How Latin American Buyers Can Source From India (Step-by-Step)

Step 1 - Define Sourcing Requirements

Clarify:

• product / molecule / strength
• dosage form
• expected volumes
• registration requirement
• API or finished product
• private-label or branded

Step 2 - Shortlist Qualified Indian Manufacturers

Prefer suppliers with:

• WHO-GMP / EU-GMP / USFDA compliance
• prior exports to Latin America
• strong regulatory documentation capability
• traceable quality systems

Step 3 - Request Technical & Regulatory Files

Typically includes:

• COA
• GMP certificate
• COPP / FSC
• CTD dossier (if registering)
• DMF (for APIs)
• stability data
• batch MFR records

Step 4 - Regulatory Submission & Approval

Work with:

• a local MAH
• a regulatory agent
• a distribution partner

Approval timelines vary by country.

Step 5 - Commercial & Contract Finalization

Discuss:

• MOQ
• pricing & Incoterms
• delivery cycles
• quality agreement
• pharmacovigilance responsibilities

Step 6 - Logistics & Import Coordination

Choose air or sea freight depending on urgency.

Step 7 - Long-Term Partnership Model

Once supply is stable, many companies expand into:

• private label manufacturing
• localized packaging
• CDMO / technology transfer
• market-specific SKUs
   

Common Sourcing Challenges & Practical Solutions

Why India Is a Long-Term Pharma Manufacturing Partner for Latin America

India offers an exceptionally rare combination of:

• Being a clinically compliant manufacturer on a global scale and having a vast amount of API knowledge
• Ability to scale production ensures that they can manufacture economically, provide a variety of collaboration models and have a fully developed export market to support cost-efficiency
• flexible collaboration models
• mature export ecosystem

As Latin America continues to expand healthcare coverage, strengthen supply chains, and localize pharmaceutical production, India will remain a critical sourcing and CDMO partner for the region.

This relationship is not transactional — it is strategic, long-term, and supply-chain critical.

Conclusion

The growing reliance of Latin American pharmaceutical buyers on India for obtaining cost effective products, reliability, quality, documentation of product creation and the value of partnering offers all point to the potential for an increased and extended supply chain between India and Latin America.

As a result of increased pressures on all Latin America member countries due to the economic and social conditions created by the COVID pandemic, the narrowing of all potential avenues for growth has created a need for regional companies and the better alignment of their business strategies with available resources.