India to Saudi Arabia: Apixaban Export Trade Route

To import finished pharmaceutical formulations containing Apixaban into Saudi Arabia, manufacturers must adhere to the Gulf Health Council's (GHC) registration and importation protocols. The registration process mandates the submission of a comprehensive dossier, typically in the Common Technical Document (CTD) or electronic CTD (eCTD) format. This dossier should encompass detailed information on the product's quality, safety, and efficacy. Specific requirements include:

• Product Information: Complete data on the formulation, including composition, manufacturing process, and quality control measures.

• Clinical Data: Evidence supporting the product's safety and efficacy, derived from clinical trials or relevant studies.

• Labeling and Packaging: Samples of the product's labeling and packaging, ensuring compliance with GHC standards.

• Good Manufacturing Practice (GMP) Certification: Valid GMP certificates for all manufacturing sites involved in the production, packaging, and batch release of the product.

The approval timeline for product registration can vary, typically ranging from several months to over a year, depending on the completeness of the submitted dossier and the GHC's review process. While specific product registration fees are not publicly disclosed, applicants should anticipate costs associated with dossier evaluation, GMP inspections, and administrative processing.

For Indian manufacturers, the GHC may require on-site GMP inspections to verify compliance with international manufacturing standards. These inspections assess various aspects, including facility infrastructure, quality control systems, and adherence to GMP guidelines. Successful completion of these inspections is crucial for obtaining product registration approval.

Indian pharmaceutical exporters aiming to supply Apixaban formulations to Saudi Arabia must comply with stringent GMP standards. The GHC recognizes GMP certifications that align with international benchmarks, such as those issued by the World Health Organization (WHO-GMP) or equivalent authorities. Key requirements include:

• GMP Certification: Manufacturing facilities must possess valid GMP certificates, ensuring that products are consistently produced and controlled according to quality standards.

• Quality Management Systems: Implementation of robust quality management systems covering all aspects of production, from raw material sourcing to final product release.

• Documentation and Record-Keeping: Comprehensive documentation of manufacturing processes, quality control tests, and batch records to facilitate traceability and compliance verification.

As of March 2026, specific details regarding Indian facilities currently approved by the GHC for Apixaban formulations are not publicly available. Similarly, information on recent inspections or regulatory actions by the GHC against Indian pharmaceutical companies is not disclosed. Manufacturers are advised to maintain open communication with regulatory authorities and ensure continuous compliance with GMP standards to facilitate market access.

Between January 2024 and March 2026, several regulatory developments have impacted Indian pharmaceutical exports to Saudi Arabia:

• Revised GMP Regulations in India: In January 2024, India's Ministry of Health revised its GMP regulations to align with global standards. The updated rules introduced elements such as pharmaceutical quality systems (PQS), quality risk management (QRM), product quality reviews (PQR), and validation of equipment. These enhancements aim to ensure the production of high-quality, globally acceptable drugs.

• GCC Harmonization Efforts: The Gulf Cooperation Council (GCC) has been working towards harmonizing GMP regulations across member states, including Saudi Arabia. This initiative seeks to streamline registration processes and facilitate mutual recognition of GMP certifications, potentially easing the entry of compliant pharmaceutical products into the Saudi market.

Manufacturers should stay informed about these developments and adapt their compliance strategies accordingly to maintain and expand their market presence in Saudi Arabia.

TARIFF_NOTES: Pharmaceutical products under HS code 30049099 are exempt from import duties in Saudi Arabia.

Apixaban, an anticoagulant used to prevent and treat blood clots, has seen increasing demand in Saudi Arabia due to the rising prevalence of cardiovascular diseases and an aging population. In 2024, the Saudi Arabian pharmaceutical market was valued at approximately $10 billion, with cardiovascular drugs accounting for a significant portion. The country's commitment to universal health coverage and substantial healthcare spending further drive the demand for effective anticoagulant therapies like Apixaban.

While Saudi Arabia has been investing in domestic pharmaceutical manufacturing, a considerable portion of specialized medications, including Apixaban formulations, are still imported. In 2025, India exported $2.5 million worth of finished pharmaceutical formulations containing Apixaban to Saudi Arabia, representing 1.4% of India's total Apixaban formulation exports. This indicates a reliance on imports to meet the country's demand for this specific medication.

Saudi Arabia imposes a 0% import duty on pharmaceutical products classified under HS code 30049099, which includes finished formulations containing Apixaban. This exemption aligns with the country's policy to facilitate access to essential medications. Additionally, there are no anti-dumping duties or specific free trade agreements between India and Saudi Arabia affecting pharmaceutical tariffs. However, importers must comply with the Saudi Food and Drug Authority's (SFDA) regulations, including product registration and adherence to labeling requirements.

India is a major supplier of Apixaban formulations to Saudi Arabia, with exports totaling $2.5 million in 2025. Other significant suppliers include European Union manufacturers and China, which also export finished pharmaceutical products to the Saudi market. India's share of Saudi Arabia's total Apixaban imports is substantial, reflecting its competitive pricing and established pharmaceutical manufacturing capabilities.

In terms of pricing, Indian manufacturers offer Apixaban formulations at competitive rates compared to European counterparts. For instance, in June 2025, Apixaban prices in China reached $24,295 per metric ton, while in Germany, prices were $55,269 per metric ton. This pricing advantage, coupled with India's robust pharmaceutical industry, positions Indian exporters favorably in the Saudi Arabian market.

India is a leading global producer of generic pharmaceuticals, accounting for approximately 20% of the global supply by volume. The country has a robust manufacturing infrastructure with 752 FDA-approved sites, 2,050 WHO-GMP certified plants, and 286 EDQM-approved facilities as of 2024. This extensive network enables large-scale production of finished dosage forms, including tablets and capsules containing Apixaban. Indian manufacturers benefit from cost-effective production due to economies of scale, competitive labor costs, and a well-established supply chain. Notably, companies like Alembic Pharmaceuticals have received multiple approvals from the US FDA for generic medicines between 2024 and 2025, reflecting their compliance with stringent international quality standards.

In the second quarter of 2025, the average price of Apixaban in India was $30,369 per metric ton, compared to $24,295 in China and $55,269 in Germany. While China's prices are lower, Indian manufacturers are often preferred due to their adherence to international quality standards, including FDA and WHO-GMP certifications. European manufacturers, though offering high-quality products, have significantly higher prices. In Saudi Arabia, Indian Apixaban formulations are well-accepted, with major buyers like Sudair Pharma Company and Boston Oncology Arabia sourcing from Indian suppliers. Indian manufacturers have a strong track record of supply reliability, supported by a vast network of WHO-GMP certified plants.

Indian manufacturers have demonstrated a strong track record of supply reliability for Apixaban formulations. The country's pharmaceutical industry includes 752 FDA-approved sites and 2,050 WHO-GMP certified plants as of 2024, ensuring consistent production capacity. Companies like Granules India have expanded their finished dosage capabilities, with their Genome Valley facility in Hyderabad receiving U.S. FDA approval in August 2025, adding an additional 10 billion doses of formulation capacity. This expansion enhances the supply chain's resilience and capacity to meet international demand. Indian manufacturers also maintain stringent regulatory compliance, with facilities regularly inspected and approved by international agencies, ensuring consistent quality and supply reliability.

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

• Minimum Order Quantities (MOQs): Negotiate MOQs that align with your demand forecasts to optimize inventory levels and reduce holding costs.

• Payment Terms: Establish clear payment terms, typically involving letters of credit or advance payments, to ensure smooth transactions.

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

• Regulatory Compliance: Verify that suppliers have the necessary certifications, such as WHO-GMP and FDA approvals, to ensure product quality and regulatory compliance.

By meticulously following these guidelines, Saudi Arabian companies can ensure the selection of reliable Indian suppliers for Apixaban formulations, thereby safeguarding product quality and patient health.