Injectable Manufacturer in China: How Farbe Firma Approaches the NMPA Import Route
Injectable Manufacturer in China: How Farbe Firma Approaches the NMPA Import Route
Last Updated: 27 September 2026
TL;DR: China is one of the largest injectable markets in the world, and one of the most demanding to enter. An imported generic needs its own registration with the National Medical Products Administration (NMPA), normally as a chemical drug in Class 5.2, backed by a CTD dossier that proves consistency with the Chinese reference product. The overseas licence holder must appoint a Chinese legal entity that shares its liability, the factory can be inspected by Chinese inspectors, and a WHO-GMP certificate does not replace any of this. Farbe Firma approaches China as a long-term partnership project, not a quick export.
Key Takeaways
The Drug Administration Law, revised in 2019 and in force since 1 December 2019, requires an overseas marketing authorisation holder to designate a Chinese enterprise legal person to perform its obligations, with joint and several liability.
Imported generics already marketed abroad are registered as chemical drug Class 5.2 under the Provisions for Drug Registration of 2020, and must match the Chinese reference product in quality and efficacy. eCTD became fully implemented for chemical drugs from 1 March 2026.
Chinese inspectors can inspect overseas factories, and a WHO-GMP certificate is not accepted in place of that. National volume-based procurement rules published in June 2026 ask overseas-made generics to show a GMP inspection by the Chinese regulator.
Labels and package inserts must be in standard Chinese characters, and under the Implementing Regulations in force since 15 May 2026 the insert must identify the domestic responsible person.
Introduction: What an Injectable Manufacturer in China's Import Market Has to Satisfy
Chinese public hospitals account for the majority of the country's drug spending, and injectables are a large part of what they buy. Industry data for 2025 put public-hospital drug sales at roughly 59 percent of the national total, with chemical injectables alone worth hundreds of billions of yuan. At the same time, pricing pressure from national volume-based procurement has pushed that injectable segment to its lowest level in more than a decade. For an overseas manufacturer, that combination means a market of real scale where only well-prepared, cost-disciplined suppliers can compete.
The legal framework has also been modernised in stages. The Drug Administration Law introduced the marketing authorisation holder system in 2019. The Provisions for Drug Registration, SAMR Order No. 27, took effect on 1 July 2020. China joined the International Council for Harmonisation as a regulatory member in 2017, which is why dossiers follow the ICH CTD structure. Most recently, the State Council rewrote the Implementing Regulations of the Drug Administration Law, with the new text in force from 15 May 2026. Any serious plan for China has to be built on these current texts, not on older summaries.
What Sets a World-Class Injectable Manufacturer in China's Market Apart
The first discipline is structure. A foreign company cannot simply hold a Chinese licence at arm's length. Article 9 of the registration provisions requires an overseas applicant to designate a Chinese enterprise legal person to handle registration, and Article 38 of the Drug Administration Law requires the overseas licence holder to designate a Chinese entity that performs its obligations and shares joint and several liability. Since 1 July 2025, NMPA Announcement 2024 No. 137 has set out what this domestic responsible person must have, including a quality system and dedicated quality staff. Choosing that partner well is the most important commercial decision in the project.
The second discipline is equivalence. A Class 5.2 generic must be consistent with the reference product that NMPA designates, and the 2020 technical requirements for injectable generics are exacting. Excipient types should normally match the reference product, with amounts within 95 to 105 percent of it. Differences in buffers, antioxidants or preservatives need justification, and the dossier must include sterilisation or aseptic-process validation with media fills, depyrogenation of primary packaging, container-closure integrity and filter compatibility studies. The active ingredient, excipients and packaging are reviewed together with the product, and foreign suppliers file their data in Chinese through the CDE registration platform or inside the product dossier.
Quality Systems Behind Every Sterile Injectable We Prepare for China
Farbe Firma manufactures under WHO-GMP certification in Gujarat, India, with ISO Class 5 aseptic filling zones under continuous environmental monitoring. Batches are released against the compendium the partner names, whether IP, BP, USP or EP, with HPLC, GC, Karl Fischer, LAL endotoxin, sterility and particulate testing. For a China project, those specifications are then aligned with the Chinese Pharmacopoeia and the reference product, because registration testing is organised by China's national institute through port drug testing institutes.
Stability studies follow ICH Q1A, with photostability under ICH Q1B where needed, and our dossiers are written in CTD format from the start. We are clear about one point: our WHO-GMP certificate supports a partner's due diligence, but it is not a substitute for Chinese review. The 2018 provisions on overseas inspection allow Chinese inspectors to visit foreign manufacturing sites, and refusing or delaying an inspection is treated as non-compliance. We plan our documentation and site readiness on the assumption that an on-site inspection will happen.
Why Global Buyers Consider Farbe Firma When Choosing an Injectable Manufacturer in China's Import Market
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 registrations in China that we have not obtained, and product status is confirmed product by product. What we offer a Chinese partner is a manufacturing base with aseptic capability, CTD and ACTD dossier experience, and a team that understands the difference between a WHO-format certificate and a Chinese approval.
Once a product is approved, the commercial rules take over. Imports arrive through authorised ports, where customs releases goods against an import drug clearance form and the first import is tested before sale. Labels and inserts must be in Chinese, with the Chinese text prevailing. Public hospitals buy through provincial procurement platforms, and under the two-invoice system a foreign product's single national general agent can be treated as the manufacturer. Since May 2018 most ordinary medicines have carried a zero provisional import duty, although the current rate for each product should be checked.
National volume-based procurement is the other major gate. By July 2026 China had run 12 national batches covering 555 molecules. The twelfth batch allowed overseas licence holders to bid through their domestic responsible person, but asked for five years of production experience in the same dosage form and a Chinese GMP inspection for overseas-made generics. The 2025 National Reimbursement Drug List, in force since 1 January 2026, lists 3,253 drugs. We build these requirements into project plans from day one.
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Frequently Asked Questions (FAQ)
Can an Indian injectable manufacturer register products in China?
Yes, through the imported drug route. A generic already marketed abroad is usually filed as chemical drug Class 5.2 with NMPA, in CTD format, and must be shown to be consistent with the Chinese reference product. The applicant designates a Chinese enterprise legal person to handle registration, and the certificate is valid for five years.
Does NMPA accept a WHO-GMP certificate?
Not in place of its own assessment. We found no provision that accepts WHO-GMP or an Indian GMP certificate instead of Chinese review, and Chinese inspectors can inspect overseas sites. The 2026 volume-based procurement rules also ask overseas-made generics to show a GMP inspection by the Chinese regulator.
Does a foreign manufacturer need a local partner in China?
Yes. The Drug Administration Law requires an overseas licence holder to designate a Chinese enterprise legal person that performs its obligations with joint and several liability. Since July 2025 this domestic responsible person must meet NMPA's conditions, and it is named in the package insert.
How long does NMPA review take?
The registration provisions set a 200-day technical review clock for a marketing application. Registration testing, possible inspections and time taken to answer questions come on top of that, so realistic project plans allow considerably longer than the statutory clock.
Can imported injectables take part in volume-based procurement?
Yes, if they qualify. The twelfth national batch in 2026 allowed overseas licence holders to bid through their domestic responsible person, provided the product met the equivalence rules, the maker had recent same-dosage-form production experience and the site had passed a Chinese GMP inspection.
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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