How India Exports Primaquine to the World

In the United States, Primaquine Phosphate Tablets USP, 26.3 mg (15 mg base), received approval under Abbreviated New Drug Application (ANDA) 203924 on December 30, 2011. This approval, granted to Alvogen, Inc., signifies the product's bioequivalence to the reference listed drug by Sanofi Aventis US, LLC. The approval letter and related documents are accessible through the FDA's official channels.

The FDA's Orange Book lists multiple approved ANDAs for Primaquine, reflecting a competitive market landscape. However, specific details regarding the number of approved ANDAs and recent approvals require direct consultation of the Orange Book database. Importantly, there are no current import alerts or significant regulatory barriers affecting the importation of Primaquine into the U.S. market. Given the presence of 116 active Indian exporters, the U.S. market offers substantial opportunities for Indian manufacturers, provided they adhere to FDA regulations and maintain consistent product quality.

In the European Union, Primaquine is authorized for use in malaria treatment protocols. The European Medicines Agency (EMA) provides guidelines for its use, particularly in combination therapies for Plasmodium falciparum malaria. The EMA emphasizes adherence to Good Manufacturing Practice (GMP) standards, ensuring that medicinal products meet quality and safety requirements. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the marketing authorization of medicinal products, including Primaquine. Manufacturers must comply with UK-specific regulatory requirements, which align closely with EU standards.

Primaquine is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its importance in global health. The WHO recommends its use in specific malaria treatment regimens, particularly for the radical cure of Plasmodium vivax and Plasmodium ovale malaria. While Primaquine is not currently listed under the WHO Prequalification of Medicines Programme, it is recognized in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality across different regions.

In India, Primaquine is classified under Schedule H of the Drugs and Cosmetics Rules, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) regulates the pricing of essential medicines; however, specific ceiling prices for Primaquine are subject to periodic revisions. Manufacturers intending to export Primaquine must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with export regulations and quality standards.

Primaquine is an established antimalarial drug with no active patents or exclusivity rights, allowing for generic production and export. This open market status has led to significant generic competition, contributing to the presence of 116 active Indian exporters and a diverse global market reach.

In November 2025, the European Medicines Agency (EMA) updated its guidelines on the use of antimalarial drugs, including Primaquine, emphasizing the need for adherence to GMP standards and proper pharmacovigilance practices. (ema.europa.eu)

In January 2026, the UK Food Standards Agency (FSA) implemented new regulations under the Genetic Technology (Precision Breeding) Act 2023, affecting the approval process for certain medicinal products. While these regulations primarily focus on precision-bred organisms, they reflect the UK's evolving regulatory landscape, which may indirectly impact the pharmaceutical sector. (food.gov.uk)

These developments highlight the dynamic nature of the regulatory environment affecting Primaquine and underscore the importance for exporters to stay informed and compliant with international standards.

India's pharmaceutical industry, including the production of Primaquine, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 70–80% of global KSM supply and 60–70% of intermediate supply are controlled by China, making it a dominant player in the API sector. This dependency poses significant risks, as any disruption in Chinese supply chains can directly impact India's pharmaceutical manufacturing capabilities.

Recent events have highlighted these vulnerabilities. In early 2026, the Strait of Hormuz crisis led to substantial disruptions in global shipping routes, affecting the transportation of pharmaceuticals and their raw materials. The crisis caused a sharp decline in maritime transit, with tanker traffic dropping by approximately 70% and over 150 ships anchoring outside the strait to avoid risks. Such geopolitical tensions underscore the fragility of supply chains dependent on specific regions for critical raw materials.

Our proprietary trade data from 2022 to 2026 indicates that the top five exporters of Primaquine from India account for 46.7% of the total export value, with BDH Industries Limited leading at 17.3%. This concentration suggests a moderate risk, as disruptions affecting these key suppliers could significantly impact the availability of Primaquine in international markets.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to bolster domestic API and KSM production. The scheme has led to the inauguration of two greenfield plants dedicated to manufacturing critical molecules like Penicillin G and Clavulanic Acid, essential components in various antibiotics. While these initiatives are steps toward reducing import dependence, the effectiveness of the PLI scheme in diversifying the supplier base for Primaquine remains to be fully realized.

Geopolitical tensions have had a profound impact on global supply chains. The 2026 Strait of Hormuz crisis, for instance, led to a significant decline in maritime transit, affecting the transportation of pharmaceuticals and their raw materials. Additionally, the ongoing Iran war has disrupted global supply chains, affecting the distribution of pharmaceuticals from India. Such disruptions can lead to delays and increased costs in the supply of Primaquine to international markets.

Furthermore, regulatory actions have highlighted quality concerns in API manufacturing. In February 2025, the FDA issued warning letters to API manufacturers in China and India for significant deviations from current Good Manufacturing Practice (cGMP), underscoring ongoing issues with the quality of essential components for critical medications. Such regulatory scrutiny can lead to supply interruptions and necessitate shifts in sourcing strategies.

• Diversify Supplier Base: Engage with multiple API and KSM suppliers across different regions to reduce dependency on a single source.

• Enhance Domestic Production: Invest in domestic manufacturing capabilities for APIs and KSMs, leveraging government incentives like the PLI scheme to build a more resilient supply chain.

• Strengthen Quality Assurance: Implement stringent quality control measures and regular audits to ensure compliance with international standards, mitigating risks associated with regulatory actions.

• Develop Contingency Plans: Establish robust contingency plans to address potential disruptions in supply chains due to geopolitical tensions or natural disasters.

• Monitor Geopolitical Developments: Stay informed about global political events and assess their potential impact on supply chains to proactively address emerging risks.

RISK_LEVEL: MEDIUM