API & Intermediates

Japan's Ministry of Health, Labour and Welfare estimates that nearly 50% of Japanese generic companies import at least some APIs from India. Yet India's contribution to Japan's total API market remains under 2%, despite Japan being the world's third-largest pharmaceutical market.

That gap exists because Japanese requirements are genuinely distinctive: residual solvent limits a fraction of ICH thresholds, tighter impurity limits, and a regulatory system spanning ICC, AFM, change applications and polymorphism review.

This is where Kyodo adds value, for Japanese companies and Indian manufacturers alike, with a deep, long-standing understanding of exactly these requirements. We also support local Japanese API companies with cost-competitive intermediates sourced or developed in India, an area we've expanded through our relationships with Japanese CMOs.

Under the Economic Security Promotion Law, Japan's Ministry of Health, Labour and Welfare has designated four β-lactam antibiotics as specified important goods and set 2030 as the deadline for a domestic system capable of covering national demand if overseas supply is disrupted. The policy does not ask Japan to stop importing. It requires supply plans built on the combined use of overseas-derived and domestically-derived raw materials in normal times, and treats fully domestic supply as unrealistic for now. That leaves every affected manufacturer with the same question: which overseas source. Kyodo works with Japanese pharmaceutical companies on precisely that, qualifying Indian API and intermediate supply against Japanese requirements, so the imported half of a supply-securing plan no longer rests on a single country.

• The four designated drugs are cefazolin, cefmetazole, ampicillin/sulbactam and tazobactam/piperacillin. β-lactams account for more than 85% of the injectable antibacterial formulations used in Japan.
• The policy's first milestone, domestic API plants completed in 2024, runs on overseas-derived raw materials. Where the mother nucleus and side chains are sourced is the immediate question, not a 2030 one.
• Domestic API from domestic raw materials follows by 2028, with the full system in place by 2030. Diversified imports carry the intervening years.
• Cost remains the open issue. Who absorbs the higher cost of domestic production is still recorded as a future issue to be considered, which puts the cost base of the imported half under real scrutiny.

Kyodo also aims to build a stronghold in Southeast Asia, the Middle East, North Africa, and Latin America, drawing on our customer database of end users, local agents, and manufacturers to simplify the pharmaceutical supply chain across global markets. We welcome collaboration proposals from parties looking to strengthen their global footprint or build reliable supply chains from Asia.