India to United Kingdom: Apixaban Export Trade Route

To import finished pharmaceutical formulations containing Apixaban into the UK, the following approvals and registrations are necessary:

1. Manufacturer's Licence (MIA): Entities involved in the importation of medicinal products must hold a Manufacturer's Licence, which authorizes the importation and, if applicable, the manufacturing or assembly of medicines.

2. Marketing Authorisation (MA): Each medicinal product must have a valid Marketing Authorisation, confirming that the product meets the required standards of safety, quality, and efficacy.

3. Wholesale Dealer's Licence (WDA(H)): If the imported products are to be distributed within the UK, a Wholesale Dealer's Licence is required.

The application process for these licences involves submitting a Common Technical Document (CTD) or electronic Common Technical Document (eCTD) dossier, which includes comprehensive data on the product's quality, safety, and efficacy. The MHRA aims to process applications within 210 days, though timelines can vary based on the complexity of the submission. Fees for applications are subject to periodic updates; applicants should consult the MHRA's official fee schedule for the most current information.

Additionally, the MHRA requires Good Manufacturing Practice (GMP) inspections of manufacturing facilities, including those located in India, to ensure compliance with UK standards. These inspections assess the manufacturing processes and quality control systems in place.

Indian manufacturers exporting Apixaban formulations to the UK must comply with the following GMP certifications:

1. MHRA GMP Certification: Manufacturing sites must be inspected and certified by the MHRA to confirm adherence to UK GMP standards.

2. EU GMP Certification: Compliance with European Union GMP standards is also required, as the UK aligns its regulations with EU directives.

The MHRA maintains a database of GMP certificates issued to manufacturing sites. For instance, as of February 5, 2024, Baxter Pharmaceuticals India Private Limited, located in Ahmedabad, India, holds a valid GMP certificate issued by the MHRA. Regular inspections are conducted to ensure ongoing compliance.

Recent inspections have identified areas of non-compliance in some Indian facilities. For example, in December 2016, Mylan Laboratories Limited in Sinnar, India, was issued a GMP certificate following an inspection. Manufacturers are advised to stay updated on inspection outcomes and address any identified deficiencies promptly.

Between 2024 and 2026, several regulatory developments have impacted Indian pharmaceutical exports to the UK:

1. Updated GMP Certificates: In November 2025, Piramal Pharma Solutions' facility in Grangemouth, UK, received updated MHRA GMP certificates following a successful compliance report and desktop inspection. This underscores the MHRA's commitment to maintaining high GMP standards.

2. GMP Certification for Biologics: In January 2026, WuXi Biologics' facilities in Wuxi, China, obtained GMP certification from the MHRA for the commercial manufacturing of an ophthalmic biologic. This highlights the MHRA's ongoing efforts to ensure GMP compliance in global manufacturing sites.

These developments reflect the MHRA's continuous oversight and the importance of maintaining GMP compliance for manufacturers exporting to the UK.

In 2024, the global market for Apixaban, marketed as Eliquis, was valued at approximately $20.1 billion, with projections indicating growth to $31.5 billion by 2034, reflecting a compound annual growth rate (CAGR) of 4.6%. North America accounted for over 34.1% of this market in 2024, generating revenue of $6.9 billion. (media.market.us)

The United Kingdom's demand for Apixaban is driven by several factors:

• Prevalence of Thromboembolic Disorders: An aging population contributes to a higher incidence of conditions such as atrial fibrillation, deep vein thrombosis (DVT), and pulmonary embolism (PE), necessitating anticoagulant therapies.

• Healthcare Spending: The UK's National Health Service (NHS) provides universal health coverage, ensuring access to essential medications, including anticoagulants like Apixaban.

• Clinical Preference: Apixaban is favored due to its efficacy and safety profile, leading to its widespread adoption for stroke prevention in atrial fibrillation and treatment of DVT and PE.

While specific data on the UK's domestic production versus imports of Apixaban formulations is not readily available, the import data indicates a reliance on international suppliers, including Indian manufacturers.

Pharmaceutical products under HS code 30049099, including Apixaban formulations, are subject to a 0% Most-Favored-Nation (MFN) import duty rate in the United Kingdom. This exemption aligns with the UK's policy to facilitate access to essential medicines.

As of March 2026, there is no Free Trade Agreement (FTA) between India and the United Kingdom specifically affecting pharmaceutical tariffs. Additionally, there are no anti-dumping duties imposed on Apixaban imports from India.

India is a significant supplier of Apixaban formulations to the United Kingdom, accounting for $3.7 million in trade value across 113 shipments from 13 Indian manufacturers/exporters. This represents 2.0% of India's total Apixaban formulation exports, valued at $179.9 million.

The top Indian exporters to the UK include:

1. INTAS PHARMACEUTICALS LIMITED ($2.1 million)

2. TORRENT PHARMACEUTICALS LTD ($0.7 million)

3. UNISON PHARMACEUTICALS PRIVATE LIMITED ($0.3 million)

4. TORRENT PHARMACEUTICALS LIMITED ($0.2 million)

5. MICRO LABS LIMITED ($0.2 million)

The primary buyers in the United Kingdom are:

1. Accord UK ($1.0 million)

2. ACCORD UK ($0.9 million)

3. TORRENT PHARMA (UK) LIMITED ($0.5 million)

4. TORRENT PHARMA UK LIMITED ($0.4 million)

5. TO THE ORDER ($0.2 million)

While India is a key supplier, other major countries supplying Apixaban to the United Kingdom include Germany and the United States. Specific data on India's share of the UK's total Apixaban imports and comparative pricing with competitors like China and EU manufacturers is not readily available.

Before engaging with an Indian manufacturer for Apixaban formulations, United Kingdom buyers should adhere to the following checklist:

When sourcing Apixaban formulations from Indian manufacturers, United Kingdom buyers should request the following documents:

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

To ensure the quality and compliance of Apixaban formulations from Indian manufacturers, implement the following audit and monitoring procedures:

Cost Estimates and Timeline:

• Audit Visits to India:
• Plan for a 3-5 day on-site audit, including travel and accommodation expenses.
• Estimated cost: £5,000 to £10,000 per audit, depending on the complexity and location.

• Remote Monitoring:
• Implement regular virtual meetings and document reviews, with minimal additional costs.

By adhering to these guidelines, United Kingdom buyers can ensure the quality and compliance of Apixaban formulations sourced from Indian manufacturers.