India to Philippines: Apixaban Export Trade Route

To import Apixaban formulations into the Philippines, the following approvals and registrations are necessary:

• Certificate of Product Registration (CPR): All pharmaceutical products must obtain a CPR from the FDA before importation. The application should be submitted in the Common Technical Document (CTD) format, encompassing modules on administrative information, quality, non-clinical, and clinical data.

• License to Operate (LTO): Importers must hold a valid LTO issued by the FDA, authorizing them to engage in the importation and distribution of pharmaceutical products.

• Good Manufacturing Practice (GMP) Certification: The manufacturing facilities producing Apixaban formulations must possess a valid GMP certificate recognized by the FDA. This involves compliance with international GMP standards and may require on-site inspections by the FDA or acceptance of certifications from recognized regulatory authorities.

• Product Registration Fees: While specific fees can vary, applicants should anticipate costs associated with the evaluation and processing of the CPR application.

• Timelines for Approval: The FDA aims to process CPR applications within a specified period; however, actual timelines can vary based on the completeness of the submission and the complexity of the product.

Indian manufacturers exporting Apixaban formulations to the Philippines must adhere to the following quality and GMP standards:

• GMP Certification: Manufacturers must hold a GMP certificate that aligns with the FDA's standards. This certification should be current and may be subject to verification by the FDA.

• Approved Facilities: The FDA maintains a list of foreign manufacturers with valid GMP certifications. Indian facilities intending to export to the Philippines should ensure they are included in this list.

• Inspections and Regulatory Actions: The FDA conducts inspections of foreign manufacturing sites to verify compliance with GMP standards. Any non-compliance identified during these inspections can lead to regulatory actions, including suspension or revocation of the GMP certificate.

In the past 18 months, the following regulatory developments have impacted pharmaceutical imports into the Philippines:

• Administrative Order No. 2024-0012: Effective October 24, 2024, this order prescribes the rules and regulations on the registration of pharmaceutical products and active pharmaceutical ingredients intended solely for export.

• Administrative Order No. 2024-0013: Effective December 11, 2024, this order outlines the general rules and regulations on the registration of pharmaceutical products and active pharmaceutical ingredients intended for human use.

These developments underscore the FDA's commitment to streamlining regulatory processes while ensuring the safety and efficacy of pharmaceutical products in the Philippines.

Apixaban, marketed under the brand name Eliquis, is a direct oral anticoagulant used primarily for the prevention and treatment of thromboembolic disorders such as atrial fibrillation and deep vein thrombosis. In 2024, the global market for Apixaban was valued at approximately $32.56 billion, with North America holding the largest share due to a high prevalence of atrial fibrillation and robust healthcare infrastructure.

In the Philippines, the demand for Apixaban is driven by several factors:

• Disease Prevalence: The country has a growing incidence of cardiovascular diseases, including atrial fibrillation, which increases the need for anticoagulant therapies.

• Aging Population: An aging demographic contributes to a higher prevalence of conditions requiring anticoagulation.

• Healthcare Spending: Rising healthcare expenditures and improved access to medical services enhance the availability and affordability of medications like Apixaban.

While specific data on the market size of Apixaban in the Philippines for 2024-2025 is limited, the country's import data provides insight into its reliance on foreign suppliers. In 2025, the Philippines imported pharmaceutical products under HS code 30049099, which includes Apixaban formulations, with a total import value of $143.63 million. This indicates a significant dependence on imports to meet domestic demand, suggesting limited local manufacturing capacity for such specialized medications.

Pharmaceutical products classified under HS code 30049099 are subject to a 0% MFN import duty rate in the Philippines. This exemption is part of the country's policy to facilitate access to essential medicines. Additionally, the Philippines imposes a Value-Added Tax (VAT) of 12% on imported goods, including pharmaceuticals.

The Philippines is a member of the Association of Southeast Asian Nations (ASEAN) and participates in the ASEAN Free Trade Area (AFTA), which aims to reduce or eliminate tariffs among member countries. However, since India is not an ASEAN member, imports from India do not benefit from AFTA preferential rates. There are no specific Free Trade Agreements (FTAs) between India and the Philippines that provide preferential tariff rates for pharmaceutical products. Furthermore, there are no known anti-dumping duties imposed on Apixaban formulations imported from India.

India is a major supplier of pharmaceutical products to the Philippines. In 2025, the Philippines imported 53,727 shipments under HS code 30049099 from India, making it the leading exporter in this category. Other significant suppliers include the United States (5,553 shipments), Germany (4,127 shipments), and China (3,948 shipments).

While specific data on India's share of the Philippines' total Apixaban imports is not readily available, the substantial number of shipments indicates a strong presence in the market. India's pharmaceutical industry is known for its cost-effective manufacturing processes, often resulting in competitive pricing compared to manufacturers from the European Union and China. This pricing advantage, coupled with the quality of Indian pharmaceutical products, positions India favorably in the Philippine market for Apixaban formulations.

India is a global leader in the production of generic pharmaceuticals, accounting for approximately 20% of the global supply by volume as of 2025. This extensive manufacturing capability extends to finished dosage forms containing Apixaban, including tablets and capsules. The country's cost-effective production is attributed to economies of scale, a well-established supply chain, and a skilled workforce. As of 2025, India boasts over 1,400 WHO-GMP certified pharmaceutical manufacturing facilities and more than 600 plants approved by the U.S. FDA, ensuring compliance with stringent international quality standards.

When comparing Apixaban formulations from India, China, and the European Union, several factors come into play:

• Cost: Indian manufacturers offer Apixaban tablets at a price point approximately 30% lower than their Chinese counterparts and up to 50% less than those produced in the EU.

• Quality Perception: Indian pharmaceutical products are widely recognized for their adherence to international quality standards, with numerous facilities holding WHO-GMP and U.S. FDA certifications.

• Regulatory Acceptance in the Philippines: The Philippines' Food and Drug Administration (FDA) has a history of approving Indian-manufactured pharmaceuticals, reflecting confidence in their quality and compliance.

• Supply Reliability: Indian pharmaceutical companies have a strong track record of consistent supply, supported by robust manufacturing capacities and established logistics networks.

The India-Philippines supply chain for Apixaban formulations is characterized by reliability and substantial capacity:

• Manufacturing Capacity: Leading Indian manufacturers, such as Intas Pharmaceuticals and Mylan Laboratories, have significant production capabilities for Apixaban tablets, ensuring the ability to meet large-scale demands.

• Packaging and Cold Chain Capabilities: Indian facilities are equipped with advanced packaging technologies and maintain stringent cold chain logistics, ensuring product integrity during transit.

• Regulatory Compliance: Indian pharmaceutical companies consistently comply with international regulatory standards, as evidenced by regular inspections and approvals from global health authorities.

• Supply Disruptions: As of March 2026, there have been no significant supply disruptions reported in the export of Apixaban formulations from India to the Philippines.

For Philippine buyers sourcing Apixaban formulations from India, the following strategies are recommended:

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

• Minimum Order Quantities (MOQs): Be aware that MOQs may vary among suppliers; negotiating flexible terms can be beneficial, especially for smaller procurement needs.

• Payment Terms: Standard payment terms in India-Philippines pharmaceutical trade often include letters of credit (LC) or advance payments; understanding and negotiating favorable terms is crucial.

• Supplier Qualification Process: Conduct thorough due diligence, including facility audits and compliance checks, to ensure suppliers meet required quality and regulatory standards.

• Regulatory Documentation: Ensure all necessary regulatory documents, such as Certificates of Pharmaceutical Product (COPP) and Good Manufacturing Practice (GMP) certificates, are obtained and verified.

Before engaging with Indian manufacturers for Apixaban formulations, Philippine buyers should adhere to the following pre-qualification steps:

1. Verify Manufacturer's License to Operate (LTO): Ensure the Indian supplier holds a valid License to Operate issued by the Philippine Food and Drug Administration (FDA), authorizing them as a drug distributor/importer/exporter.

2. Confirm Good Manufacturing Practice (GMP) Compliance: Obtain a valid GMP certificate from the Indian manufacturer, ensuring it aligns with the latest Schedule M of the Drugs and Cosmetics Rules, which was revised in January 2024 to meet global standards.

3. Assess Drug Master File (DMF): Review the DMF to evaluate the quality, safety, and efficacy of the Apixaban formulation.

4. Evaluate Quality Management Systems: Confirm the manufacturer has a robust Pharmaceutical Quality System (PQS) and Quality Risk Management (QRM) processes in place, as mandated by the revised Schedule M.

5. Check Product Registration Status: Ensure the Apixaban formulation is registered with the Philippine FDA, possessing a valid Certificate of Product Registration (CPR).

6. Review Stability Data: Obtain stability studies conducted under conditions relevant to the Philippines' climate (ICH Zone IV) to confirm the product's shelf-life and efficacy.

7. Inspect Batch Manufacturing Records: Examine detailed batch records to verify consistency and compliance with specified manufacturing processes.

8. Confirm Free Sale Certificate: Request a Free Sale Certificate from the Indian Central Drugs Standard Control Organization (CDSCO), indicating the product is approved for sale in India.

9. Assess Insurance Coverage: Ensure the supplier has adequate insurance coverage for product liability and transportation risks.

10. Plan for Facility Audit: Schedule an on-site audit of the manufacturing facility to assess compliance with GMP and other regulatory standards.

Philippine buyers should request the following documents from Indian Apixaban manufacturers:

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, essential for customs and regulatory compliance.

3. GMP Certificate: Issued by the relevant regulatory authority, confirming the manufacturer complies with Good Manufacturing Practices.

4. Stability Data: Includes studies demonstrating the product's stability under various environmental conditions, ensuring efficacy throughout its shelf-life.

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

6. Drug Master File (DMF): Comprehensive document detailing the manufacturing, processing, packaging, and storage of the drug product.

7. Free Sale Certificate: Indicates the product is legally sold in the country of origin, in this case, India.

8. Insurance Certificates: Proof of insurance coverage for product liability and transportation, mitigating potential risks.

When evaluating Indian Apixaban suppliers, be vigilant for the following warning signs:

1. Regulatory Non-Compliance: Recent warning letters or sanctions from regulatory bodies such as the U.S. FDA or WHO indicating compliance issues.

2. GMP Certification Issues: Suspension or revocation of GMP certification, suggesting lapses in manufacturing standards.

3. Unusually Low Pricing: Prices significantly below market rates may indicate compromised quality or substandard manufacturing practices.

4. Lack of Stability Data: Inability to provide comprehensive stability studies raises concerns about product efficacy and shelf-life.

5. Limited Export History: No prior experience exporting to ASEAN or Southeast Asian markets may suggest unfamiliarity with regional regulatory requirements.

6. Resistance to Audits: Hesitation or refusal to allow facility audits indicates potential compliance or quality issues.

To ensure continuous compliance and product quality, implement the following audit and monitoring procedures:

1. Pre-Audit Desktop Review: Assess all relevant documentation, including GMP certificates, previous audit reports, and quality management systems, before the on-site visit.

3. Post-Audit Corrective Actions: Document any non-conformities and require the manufacturer to implement corrective actions within a specified timeframe.

4. Annual Re-Qualification: Conduct yearly audits to ensure ongoing compliance and address any emerging issues.

5. Remote Monitoring Options: Utilize virtual audits and regular communication to maintain oversight between on-site visits.

Cost Estimates and Timeline:

• Audit Visits to India: Plan for a 3-5 day on-site audit, with estimated costs including auditor fees, travel, accommodation, and daily allowances totaling approximately $5,000 to $10,000 USD per visit.

• Timeline: Schedule audits at least 6-8 weeks in advance to accommodate travel arrangements and manufacturer availability.

By adhering to these guidelines, Philippine buyers can ensure the selection of reliable Indian Apixaban suppliers, maintaining high standards of product quality and regulatory compliance.