Injectable Manufacturer in Japan: How Farbe Firma Approaches the PMDA Partner Route
Injectable Manufacturer in Japan: How Farbe Firma Approaches the PMDA Partner Route
Last Updated: 27 September 2026
TL;DR: Japan has one of the most mature generic markets in the world, with generic volume share reported at 88.8 percent in September 2025, and a regulator that expects the same standards from foreign sites as from Japanese ones. An overseas injectable maker needs Foreign Manufacturer Accreditation for its site, a product approval held by or through a Japanese marketing authorisation holder, a PMDA GMP compliance inspection and Japanese-language labelling. A WHO-GMP certificate helps as supporting evidence but does not replace any of these steps. Farbe Firma approaches Japan through partnership.
Key Takeaways
The PMD Act (Act No. 145 of 1960) requires a licensed marketing authorisation holder in Japan. A foreign manufacturer can hold the approval itself under Article 19-2, but must still appoint a Japanese MAH to carry the in-market duties.
Each overseas manufacturing site needs Foreign Manufacturer Accreditation under Article 13-3. It is granted per site, reviewed mainly on documents, and valid for five years.
PMDA checks compliance with the GMP Ordinance (MHLW Ordinance No. 179 of 2004) before approval and periodically afterwards, either on documents or on site. WHO-format certificates are supporting documents, not a substitute.
For intravenous injections given as aqueous solutions, the 2012 bioequivalence guideline waives the in-vivo study. Other injectable forms, such as suspensions or depots, are not covered by that waiver.
Introduction: What an Injectable Manufacturer in Japan Has to Satisfy
Japan's health system has pushed generics hard for two decades, and the policy has worked. The Ministry of Health, Labour and Welfare now reports generic volume share well above its long-standing 80 percent goal, and its revised roadmap aims for at least 80 percent in every prefecture and at least 65 percent by value by the end of fiscal year 2029. Hospitals buy through wholesalers at negotiated prices, and inpatient care under the DPC per-diem payment system gives hospitals a strong reason to use cost-effective injectables.
The market has also been shaken by supply problems. Since around 2020, quality failures at several Japanese generic companies led to product suspensions and shortages, and repeated price cuts squeezed margins. In May 2025 the Diet amended the PMD Act to strengthen supply stability: marketing authorisation holders will have to appoint a supply system manager and report supply suspensions, with those provisions phasing in by May 2028. For an overseas manufacturer, this means Japan values reliable supply and verifiable quality as much as price.
What Sets a World-Class Injectable Manufacturer in Japan Apart
The first discipline is choosing the right legal structure. The PMD Act offers two routes. A foreign manufacturer can supply a Japanese marketing authorisation holder, either its own subsidiary licensed under Article 12 or an established partner that holds the product approval under Article 14. Alternatively, the foreign manufacturer can hold the approval itself under Article 19-2 and appoint a Japanese MAH to handle safety and distribution. In either case the manufacturing site needs Foreign Manufacturer Accreditation, which a Japanese MAH can apply for on the manufacturer's behalf.
The second discipline is a dossier built for PMDA. Generic applications use the CTD format, and PMDA expects specifications and test methods, manufacturing details, accelerated stability data at 40 degrees and 75 percent relative humidity, and impurity limits that are in principle equal to or tighter than the originator's. Where a Japanese Pharmacopoeia monograph exists, compliance is expected. Active ingredients can be supported through Japan's Master File system under Article 80-6, which requires the foreign API maker to hold accreditation and appoint an in-country caretaker. PMDA offers pre-consultation meetings, and we recommend using them early.
Quality Systems Behind Every Sterile Injectable We Prepare for Japan
Farbe Firma manufactures under WHO-GMP certification in Gujarat, India, with ISO Class 5 aseptic filling zones under continuous environmental monitoring. Every batch is tested by HPLC, GC, Karl Fischer, LAL endotoxin, sterility and particulate matter, against the compendium the partner names, whether USP, BP, EP or IP. For a Japan project, specifications are aligned with the Japanese Pharmacopoeia and the originator product, because PMDA reviews them line by line.
Stability studies follow ICH Q1A, with photostability under ICH Q1B where needed, and our dossiers are written in CTD format from the start. PMDA decides whether a foreign GMP inspection is carried out on documents or on site, taking into account product risk and recent inspection reports from other authorities. Sterile injectables are high-risk products, so we prepare for an on-site visit. PMDA also re-inspects approved products periodically, generally every five years, so readiness is continuous, not a one-off event. Japan's regulator has been a member of the Pharmaceutical Inspection Co-operation Scheme since 2014, and its inspectors apply standards closely aligned with PIC/S GMP.
Why Global Buyers Consider Farbe Firma When Choosing an Injectable Manufacturer in Japan
Farbe Firma is a WHO-GMP certified sterile injectable manufacturer and CDMO in Gujarat, India, exporting to more than 30 countries. We do not claim Japanese approvals or accreditation that we have not obtained, and product status is confirmed product by product. What we offer a Japanese MAH is a manufacturing partner with aseptic capability, CTD and ACTD dossier experience, and the discipline to prepare for PMDA scrutiny rather than assume a shortcut exists. For a partner, that means realistic timelines, transparent data, and a plan to keep the Foreign Manufacturer Accreditation current, since it must be renewed every five years.
We are also careful about what the rules do not say. The India-Japan Comprehensive Economic Partnership Agreement, in force since 1 August 2011, commits Japan to treat Indian generic applications no less favourably than Japanese ones, but it creates no fast track and no recognition of Indian GMP. Import confirmation under Article 56-2 of the PMD Act covers unapproved, non-commercial imports and cannot be used for commercial supply. Japan's general tariff on finished medicines is free, although consumption tax is still charged at import.
Commercial planning follows the same care. New generics are typically added to the National Health Insurance price list in June and December, and prices are revised regularly, so a product must stay viable after repricing. From April 2026 the pricing rules give more recognition to companies that meet stable-supply criteria. Labels must be in Japanese, and since 1 August 2021 package inserts have been provided electronically in Japanese, reached through a code on the carton. Wholesalers and hospitals expect uninterrupted supply, so we plan safety stock and remaining shelf life with each partner, and we build these requirements into our proposals.
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Frequently Asked Questions (FAQ)
Can an Indian injectable manufacturer supply Japan?
Yes, through a Japanese marketing authorisation holder. The Indian site needs Foreign Manufacturer Accreditation under Article 13-3 of the PMD Act, the product needs PMDA approval, and the site must pass a GMP compliance inspection. The approval can be held by a Japanese MAH or by the foreign maker under Article 19-2 with an appointed MAH.
Is a WHO-GMP certificate accepted in Japan?
Only as supporting evidence. PMDA asks for recent inspection reports or certificates from other authorities, including WHO-format certificates, when planning its own GMP inspection. It then decides whether to inspect on documents or on site. The certificate does not replace compliance with Japan's GMP Ordinance.
Do generic injectables need a bioequivalence study in Japan?
Intravenous injections administered as aqueous solutions are among the dosage forms for which Japan's 2012 bioequivalence guideline waives the study. Other forms, such as intramuscular suspensions, emulsions, liposomes or depots, are not covered by that waiver and need case-by-case discussion with PMDA.
Does the India-Japan CEPA give Indian generics a fast track?
No. Article 54 of the agreement commits Japan to treat Indian generic applications no less favourably than Japanese applications and to complete the procedure within a reasonable period. It does not create a shortcut, reliance route or mutual recognition of GMP.
Does Japan charge import duty on medicines?
Japan's general tariff rate for finished medicaments under HS headings 3003 and 3004 is free. Consumption tax still applies at import, and commercial imports require the product approvals and licences described above. Japan is classified as high income by the World Bank, so supply is planned around commercial partners rather than donor-funded tenders.
Technically Reviewed By: Maulik Sudani (Technical Expert) | Jignasu Sudani (Technical Expert), Farbe Firma Pvt Ltd, Gujarat, India.
Farbe Firma Pvt Ltd - WHO-GMP certified sterile injectable manufacturer and CDMO, Gujarat, India. ISO Class 5 aseptic filling, CTD/ACTD dossiers, exporting to 30+ countries. director@farbefirma.orgRequest a Quote / View Products / Blog
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