India to Brazil: Apixaban Export Trade Route

To import Apixaban formulations into Brazil, the following approvals and registrations are mandatory:

• Marketing Authorization (MA): All pharmaceutical products must obtain a Marketing Authorization from ANVISA before commercialization. The application should be submitted in the Common Technical Document (CTD) format.

• Dossier Submission: The dossier must include comprehensive data on the product's quality, safety, and efficacy.

• Approval Timelines: ANVISA's review period for MA applications is up to 365 days for standard reviews and 120 days for priority reviews. These timelines can be extended by up to one-third of the original period.

• Product Registration Fees: Fees vary based on the product category and company size. Specific fee structures are detailed in ANVISA's regulations.

• GMP Inspection Requirements: ANVISA mandates Good Manufacturing Practice (GMP) certification for all manufacturing facilities involved in producing the pharmaceutical product. This includes on-site inspections to ensure compliance with Brazilian GMP standards.

Indian manufacturers exporting Apixaban formulations to Brazil must comply with the following GMP standards:

• ANVISA GMP Certification: Manufacturing facilities must obtain GMP certification from ANVISA, confirming adherence to Brazilian GMP requirements.

• Approved Indian Facilities: Several Indian facilities have successfully obtained ANVISA GMP certification. For instance, Naprod Life Sciences Pvt. Ltd. renewed its GMP certification for its Tarapur facility in January 2026, following a successful inspection in July 2025.

• Recent Inspections and Regulatory Actions: ANVISA conducts regular inspections of foreign manufacturing sites. The renewal of GMP certification for Naprod Life Sciences' Tarapur facility in January 2026 indicates ongoing compliance with ANVISA's standards.

In the past 18 months, ANVISA has implemented several regulatory changes affecting pharmaceutical imports:

• Resolution RDC 982/2025 (August 2025): This resolution introduced updated criteria for health risk management in granting or renewing GMP certifications, emphasizing stricter compliance measures for imported pharmaceutical products.

• Technical Note No. 200/2025 (August 2025): ANVISA established new rules for the importation and compounding of certain Active Pharmaceutical Ingredients (APIs), particularly GLP-1 receptor agonists. While this primarily affects specific APIs, it reflects ANVISA's commitment to stringent quality control measures for imported pharmaceutical substances.

These developments underscore ANVISA's ongoing efforts to enhance regulatory oversight and ensure the quality and safety of pharmaceutical products imported into Brazil.

In 2024, the Brazilian market for Apixaban formulations, marketed under the brand name Eliquis, was valued at approximately USD 618.1 million. Projections indicate a slight decline, with the market expected to reach USD 578.1 million by 2033, reflecting a compound annual growth rate (CAGR) of -1.9% from 2025 to 2033. This trend is primarily attributed to the anticipated loss of patent exclusivity, increased generic competition, and consequent price reductions.

Atrial fibrillation (AF) is the predominant indication for Apixaban use in Brazil, accounting for the largest revenue share in 2024. The aging population and the rising prevalence of AF are significant drivers of demand for anticoagulant therapies. Additionally, Brazil's universal health coverage system ensures broad access to essential medications, further supporting market demand.

While Brazil has a robust pharmaceutical manufacturing sector, the country relies on imports to meet the full demand for Apixaban formulations. In 2024, imports from India alone accounted for $14.1 million, representing 7.8% of India's total Apixaban formulation exports. This underscores the importance of international suppliers in supplementing domestic production to fulfill market needs.

Pharmaceutical products classified under HS code 30049099, including Apixaban formulations, are subject to a 0% MFN import duty rate in Brazil. This exemption aligns with Brazil's commitment to ensuring the availability of essential medicines.

In addition to import duties, imported pharmaceuticals are subject to the Imposto sobre Circulação de Mercadorias e Serviços (ICMS), a value-added tax that varies by state, typically ranging from 17% to 19%. There is no specific Free Trade Agreement (FTA) between India and Brazil that affects pharmaceutical tariffs. Furthermore, there are no anti-dumping duties imposed on Apixaban formulations imported from India, facilitating a competitive import environment.

India is a significant supplier of Apixaban formulations to Brazil, with exports totaling $14.1 million in 2024. Other major supplying countries include the United States and European Union member states, which also have established pharmaceutical export relationships with Brazil.

India's share of Brazil's total Apixaban imports is substantial, reflecting the competitive pricing and quality of Indian pharmaceutical products. Indian manufacturers are known for offering cost-effective alternatives to products from the United States and European Union, making them attractive to Brazilian importers seeking affordable yet high-quality medications.

The competitive pricing of Indian Apixaban formulations, combined with Brazil's import duty exemptions and the absence of anti-dumping measures, positions India as a key player in meeting Brazil's demand for this essential anticoagulant therapy.

India has solidified its position as a global leader in the production of generic pharmaceuticals, accounting for approximately 20% of the global supply by volume as of 2025. This dominance is underpinned by a robust infrastructure comprising over 3,000 pharmaceutical companies and a network of more than 10,500 manufacturing facilities.

Specifically, in the realm of anticoagulant therapies, Indian manufacturers have significantly expanded their capabilities in producing finished dosage forms containing Apixaban. This expansion is facilitated by the country's cost-effective manufacturing processes, which leverage economies of scale and a skilled workforce to offer competitive pricing without compromising quality.

The quality of Indian pharmaceutical manufacturing is further validated by the substantial number of facilities holding international certifications. As of 2025, India boasts over 1,400 WHO-GMP certified plants and more than 650 facilities approved by the U.S. FDA. These certifications underscore India's commitment to adhering to stringent global quality standards, making it a preferred source for Apixaban formulations worldwide.

When evaluating the cost and quality of Apixaban formulations from India, China, and the European Union (EU), several factors come into play:

• Price Per Unit: In Q2 2025, the average price of Apixaban in India was approximately $30,369 per metric ton, while in China, it stood at $24,295 per metric ton. European prices were higher, with Germany reporting $55,269 per metric ton during the same period. These figures indicate that while China's prices are slightly lower, India's competitive pricing, coupled with its quality standards, offers a balanced proposition.

• Quality Perception: Indian pharmaceutical products are widely recognized for their adherence to international quality standards, as evidenced by numerous WHO-GMP and U.S. FDA approvals. Chinese manufacturers have made significant strides in quality but still face challenges in certain markets due to historical perceptions. EU manufacturers are renowned for high-quality products; however, their higher production costs often translate to more expensive formulations.

• Regulatory Acceptance in Brazil: Brazil's regulatory authority, ANVISA, has a history of approving Indian pharmaceutical products, reflecting confidence in their quality and compliance. Chinese products have also gained acceptance, though the process can be more rigorous. EU products are readily accepted but come at a higher cost.

• Supply Reliability Track Record: Indian manufacturers have established a strong track record of reliable supply chains, supported by extensive manufacturing capacities and logistical networks. China's supply reliability has improved but can be affected by geopolitical factors. EU manufacturers offer reliable supply but may have longer lead times and higher costs.

The India-Brazil supply chain for Apixaban formulations is characterized by robust manufacturing capacities and stringent quality controls:

• Manufacturing Capacity: Leading Indian pharmaceutical companies have invested heavily in expanding their production facilities. For instance, Caplin Steriles Limited operates a state-of-the-art facility with an annual capacity of approximately 34 million vials and 7 million ophthalmic units, catering to both domestic and international markets.

• Packaging and Cold Chain Capabilities: Indian manufacturers employ advanced packaging technologies, including ALU-ALU blister packs, to ensure product stability. Comprehensive cold chain logistics are in place to maintain the integrity of temperature-sensitive formulations during transit.

• Regulatory Compliance Track Record: Indian pharmaceutical companies have a consistent history of compliance with international regulatory standards. For example, Indoco Remedies received a Certificate of EU GMP Compliance from European health authorities for its sterile drug product manufacturing facility in Goa in 2025.

• Capacity Constraints or Expansion Plans: To meet growing global demand, Indian manufacturers are continually expanding their capacities. Indoco Remedies, for instance, has been enhancing its facilities to increase production volumes and cater to international markets.

For Brazilian buyers aiming to source Apixaban formulations from India, the following strategic recommendations are advised:

• Dual-Sourcing Strategy: Engage with multiple Indian manufacturers to mitigate risks associated with supply disruptions and ensure a consistent supply chain.

• Minimum Order Quantities (MOQs): Be prepared to meet MOQs, which can vary among manufacturers. Typically, MOQs for Apixaban formulations range from 100,000 to 500,000 tablets per order.

• Payment Terms: Standard payment terms in India-Brazil pharmaceutical trade often include a 30% advance payment with the balance payable upon shipment or delivery. Negotiating favorable terms can enhance cash flow management.

• Supplier Qualification Process: Implement a rigorous supplier qualification process, including on-site audits, to assess manufacturing capabilities, quality control systems, and regulatory compliance.

• Regulatory Documentation: Ensure that suppliers provide comprehensive regulatory documentation, such as Certificates of Analysis (CoA), WHO-GMP certificates, and product dossiers, to facilitate ANVISA approval processes.

By adhering to these recommendations, Brazilian buyers can establish a reliable and cost-effective supply chain for Apixaban formulations sourced from India.

1. ANVISA Registration Verification: Confirm that the Apixaban formulation is registered with ANVISA, Brazil's National Health Surveillance Agency. This registration ensures the product meets Brazilian regulatory standards.

2. Good Manufacturing Practice (GMP) Certification: Obtain a valid GMP certificate for the manufacturing facility, issued by a recognized regulatory authority. This certification attests to the facility's adherence to quality manufacturing standards.

3. Drug Master File (DMF) Assessment: Review the DMF to understand the detailed information about the manufacturing process, controls, and specifications of the Apixaban formulation.

4. Quality Management System Evaluation: Ensure the supplier has a robust quality management system in place, encompassing quality control, assurance, and risk management protocols.

5. Regulatory Compliance History Review: Investigate the supplier's history for any regulatory actions, such as warning letters or import alerts, which may indicate compliance issues.

6. Product Stability Data Examination: Request stability data to confirm the product maintains its intended quality over its shelf life under various environmental conditions.

7. Supply Chain Transparency: Assess the supplier's supply chain to ensure traceability of raw materials and components used in the formulation.

8. Reference Checks: Contact other clients of the supplier, especially those in Latin American markets, to gather feedback on product quality and reliability.

1. Certificate of Analysis (CoA): Provides detailed results of laboratory testing for a specific batch, confirming it meets predefined specifications.

2. Certificate of Origin (CoO): Certifies the country where the product was manufactured, which is essential for regulatory and tariff purposes.

3. GMP Certificate: Issued by a competent authority, this document verifies that the manufacturing facility complies with GMP standards.

4. Stability Data: Demonstrates the product's stability over time under various environmental conditions, ensuring efficacy and safety throughout its shelf life.

5. Batch Manufacturing Records: Detailed records of the production process for each batch, ensuring consistency and traceability.

6. Drug Master File (DMF): Contains comprehensive information about the manufacturing process, controls, and specifications of the drug product.

7. Free Sale Certificate: Issued by the Central Drugs Standard Control Organization (CDSCO), this certificate indicates that the product is approved for sale in the country of origin.

8. Insurance Certificates: Proof of liability insurance coverage, providing protection against potential claims related to product quality or safety.

1. Regulatory Non-Compliance: A history of FDA warning letters or WHO-GMP suspensions suggests significant compliance issues.

2. Unrealistically Low Pricing: Prices significantly below market rates may indicate potential compromises in quality or sourcing of substandard materials.

3. Lack of Stability Data: Inability to provide comprehensive stability data raises concerns about the product's shelf life and efficacy.

4. Limited Export Experience: No track record of exporting to Latin American markets may indicate unfamiliarity with regional regulatory requirements.

5. Resistance to Audits: Hesitation or refusal to allow facility audits suggests potential issues with manufacturing practices or quality control.

1. Pre-Audit Desktop Review: Conduct a thorough review of all provided documentation, including GMP certificates, CoAs, and DMFs, to identify any discrepancies or areas of concern.

3. Post-Audit Corrective Actions: Document any identified deficiencies and require the supplier to implement corrective actions within a specified timeframe.

4. Annual Re-Qualification Process: Schedule annual audits to ensure ongoing compliance and address any emerging issues promptly.

5. Remote Monitoring Options: Utilize technology for virtual audits and continuous monitoring, especially when travel restrictions apply.

6. Cost Estimates and Timelines: Budget approximately $5,000 to $10,000 USD for an on-site audit, including travel expenses, with the process typically taking 3 to 5 days.

By adhering to this comprehensive framework, Brazilian companies can effectively qualify Indian suppliers of Apixaban formulations, ensuring product quality, regulatory compliance, and patient safety.