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

India has become a major world center in the production of pharmaceuticals and the development of contracts. Having USFDA-approved, WHO-GMP-certified and EU-GMP-compliant production plants, India provides the perfect ecosystem to countries such as Argentina in its quest to acquire high-quality at low cost pharmaceutical imports. To Argentine distributors, importers and healthcare organizations, India is a source of a broad spectrum of APIs, finished formulations, injectables and custom manufacturing (CDMO) services - all at world competitive prices. The pharmaceutical industry in Argentina is more reliant on Indian companies, as they are providing quality and cost effective imports and are particularly needed in treating chronic diseases, OTC drugs and wellness products that will be in line with the expanding home market.

Due to the increasing demand of cost effective and compliant healthcare products, a higher number of companies are sourcing their medicines from India, applying Indian CDMO services to Argentina and importing pharmaceutical products from India to enhance their supply chains and increase their product portfolios in Latin America. 

The Reasons why Argentina Businesses outsource Pharma to India

The Indian pharma producers have gained international confidence in their high compliance, size, and capabilities to produce quality products at reasonable costs. As Argentina has a developing healthcare system and focuses on low-cost therapeutic options, India provides Argentina with a partner of consistency, diversity, and quality.

The Major Advantages of Collaboration with Indian Pharma Companies

• Mos of the Indian facilities are USFDA, WHO-GMP, and EU-compliant: International-accepted regulatory standards.
• Low competitive manufacturing cost: Western manufacturers save up to 40-60% of their costs.
• Experienced formulation and API ecosystem: Approving thousands of facilities and R&D laboratories.
• Good track record of compliance: Constant auditing and international quality standards.
• Big portfolio: Generics, specialty, oncology, injectables, biosimilars, and APIs.

Most Requested Pharma Selections in Argentina from India

• APIs and Intermediates -        Paracetamol, Metformin, Amoxicillin, Atorvastatin India has medium scale API manufacturing and economical exports.
• Ready to market Formulations-          Tablets, capsules, oral liquids, syrups Existing USAFDA, MHRA and WHO-GMP approved facilities.
• Oncology/ injectables Oncology vials-  antibiotics, sterile injectables High quality sterile manufacturing facilities that have international certifications.
• OTC & Wellness-        Vitamins, supplements, probiotics, herbal extracts     Retail and hospital category of fast-moving products.
• Hospital Consumables - IV sets, syringes, gloves, catheters Supplied on institutions and government tenders.

Indian sourcing of pharma products in a step-by-step manner

The Indian sourcing is a strategic one that guarantees quality, compliance and regulatory congruence with the pharmaceutical laws in Argentina.

1) Layout Product and Regulatory Requirements

• Determine which one you require; an API, formulation, or nutraceutical.
• Define dosage, strength and the packaging.
• See ANMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica) in Argentina guidelines of registration and import documents.

2) Shortlisting Audited Indian Manufacturers.

• Select potential partners with WHO-GMP, EU-GMP or USFDA.
• Verify their export history to the Latin American countries, in particular Argentina.
• Check references, audit reports or inspection summies of clients.

3) Order Product Files and Certificate of Analysis (COA)

• Get product dossiers, batch COA and technical data sheets.
• Check compliance with necessary standards of pharmacopoeia (USP, BP, or IP).

4) Regulatory/ Dossier Submission

• Draw up CTD-form dossiers, according to the requirements of ANMAT.
• Included product monographs, safety data and GMO certifications.

5) Quality Check, Stability Data and Filings

• Perform stability tests and sample test.
• Assure suitability to Zone IVb climatic conditions (hot and humid).

6) Shipment and Supply Chain Planning

• Complete logistics routing, shipping mode and Incoterms.
• Hire certified freight companies when necessary when shipping temperature-sensitive goods.

Argentine companies who wish to import pharmaceutical products from India have to present certain documents that are in line with the ANMAT and customs regulations.

Key Documents Include:

• COPP Certificate of Pharmaceutical Product
• WHO-GMP/National GMO Certificate
• BATCH test reports Certificate of Analysis (COA)
• Registration dossier of the product (CTD format)
• Free Sale Certificate (in case)
• Bill of Lading / Airway Bill

The MSDS is a short document containing specifications for hazardous chemicals used in manufacturing goods and services. The Material Safety Data Sheet (MSDS) is a brief document that has specifications of hazardous chemicals as they are utilized in making goods and services.

India to Argentina Logistics and Shipping

The vast export network of India facilitates the easy shipment of pharmaceuticals to Argentina in various ports and by different means.

Typical Timelines:

• Sea Freight: 3-6 weeks (in Mumbai, Mundra, or Chennai to the port of Buenos Aires).
• Air Freighthood: 4-10 days of goods that are urgent or of small sizes.

Cold Chain: Suitable to the vaccines, biosimilars, and injectables that are sensitive to temperatures.

Preferred Indian Ports:

Mumbai (Nhava Sheva), Mundra and Chennai all have their own pharma export terminals and cold storage facilities.

Pharmaceutical importation and manufacturing control in Argentina is under the jurisdiction of ANMAT whereby all imported drugs should be of excellent quality, safety and efficacy.

Regulatory Highlights:

• Authority of licensing imports: ANMAT.
• Process Overview: The importers are required to submit product dossiers, GMP certificates and COPP documentation.
• Registration Timeline: 6 12 months on average, based on the completeness of dossier and type of product.
• Stability Zone: Zone IVb (30o C/75% RH) - this zone is regularly reported by the Indian manufacturers.

The collaboration of Indian firms that have already worked in submissions of ANMAT eases the registration process and also saves time in penetrating the market.

Challenge                                                                   Solution

• Regulatory Approvals-   Co-operate with audited facilities that have experience in ANMAT registration.
• Lead Times-        Placing orders and shipping 3-4 months.
• Quality Assurance-         Carry out stability and COA checks prior to bulk orders.
• Communication Barriers-            Bilingual (English-Spanish) support teams can be used to facilitate easier coordination.

Importers can overcome these challenges and safeguard the supply, regulatory acceptance, and success in the market by proactive action on such problems.

The sophisticated pharmaceutical production environment in India offers incomparable opportunities to Argentine companies that would like to find out stable and low-cost sourcing partners. Being either an import enthusiast who intends to import APIs, finished formulations or is willing to utilize Indian CDMO services on behalf of Argentina, it is possible to find quality, compliance and efficiency by working with certified Indian manufacturers.

Since Argentina is still improving healthcare accessibility, cooperation with the Indian exporters that have GMP-approved can be used to fill the supply gaps in Argentina and bring high-quality, low-cost medicines to the market.

References:

1. International Regulatory Authorities

• USFDA – U.S. Food and Drug Administration https://www.fda.gov
• WHO – World Health Organization (WHO-GMP Guidelines) https://www.who.int
• EMA – European Medicines Agency (EU-GMP Guidelines) https://www.ema.europa.eu

2. Argentine Regulatory Authority

• ANMAT – Administración Nacional de Medicamentos, Alimentos y Tecnología Médica https://www.argentina.gob.ar/anmat

3. Indian Pharmaceutical Manufacturing & CDMO Industry

• Pharmaceuticals Export Promotion Council of India (PHARMEXCIL) https://www.pharmexcil.com
• CDSCO – Central Drugs Standard Control Organization (India) https://cdsco.gov.in

4. Trade & Import Documentation

• WTO / International Trade Documentation Guidelines https://www.wto.org