Why Farbe Firma is the Leading Injectable Manufacturer in Nauru
Why Farbe Firma is the Leading Injectable Manufacturer in Nauru
Last Updated: 26 September 2026
TL;DR: Nauru modernised its medicines law in 2025. The Pharmacy Act 2025, in force since 29 August 2025, allows medicines to be imported only if they are manufactured in, and eligible for sale in, a country on its approved list, and India is on that list. Each import also needs a permit from the Secretary for Health and Medical Services, supported by certified documents from the exporting country's regulator and a batch certificate. The Government pharmacy at RON Hospital is the main buyer.
Key Takeaways
The Pharmacy Act 2025 (No. 34 of 2025) is Nauru's core medicines law. Section 39 permits imports only of medicines manufactured in and eligible for sale in an approved country listed in Schedule 3. India appears on that list alongside Australia, New Zealand, Fiji, the United Kingdom, the United States and others.
Every import needs a permit from the Secretary for Health and Medical Services. The application relies on certified documents from the regulator of the exporting country, and Customs checks the permit, those documents, the manufacturer's batch certificate and a release authorisation before goods leave the border.
The Act provides for a register of approved products in four classes, to be published in the Gazette twice a year. We have not found a published edition yet, so we confirm product status with the Department of Health and Medical Services before each supply.
Nauru is classified as high income by the World Bank and is not on the Global Fund's 2026 eligibility list or eligible for Gavi support. Medicines are bought with national funds, with the Secretary responsible for procurement under the Health and Medical Services Act 2025.
Introduction: What an Injectable Manufacturer in Nauru Has to Satisfy
Nauru is one of the smallest republics in the world, and its public health system is centred on the Republic of Nauru Hospital and the Government pharmacy that serves it. In 2025 the country replaced a patchwork of older provisions with two new statutes: the Pharmacy Act 2025, which governs how medicines are registered, imported and dispensed, and the Health and Medical Services Act 2025, which makes the Secretary for Health and Medical Services responsible for procuring medicines and vaccines.
For an overseas manufacturer, the new Pharmacy Act is unusually clear. Instead of asking whether a product has been approved by one particular regulator, it asks where the product was manufactured and whether it is eligible for sale there. India is one of fourteen approved countries in Schedule 3. That means a sterile injectable made in Gujarat and approved for sale in India can, in principle, be imported, provided a permit is granted and the supporting documents are in order. The Government's own second-reading speech described the Government pharmacy as the major source of medical supplies, and noted that Nauru had yet to establish a private pharmacy.
What Sets a World-Class Injectable Manufacturer in Nauru Apart
The first discipline is reading the words of the Act exactly. Section 39 refers to medicines manufactured in and eligible for sale in an approved country, so a product licensed only for export may not qualify. We therefore supply Nauru with products that hold a domestic Indian marketing licence, and we provide the certified regulatory documents the Secretary needs to assess a permit application. We do not assume that any product made in India is automatically acceptable.
The second discipline is keeping the site, product and importer layers separate. At the site layer, Nauru law does not inspect factories abroad; it relies on the exporting country. At the product layer, the Act creates a register of approved products and a permit for each import. At the importer layer, the Pharmacy Board licenses pharmacies, and a licensed pharmacy may import and sell by wholesale. The Act is not fully consistent on whether the Government pharmacy itself needs a permit for every class, so we ask the Department to confirm the position in writing for each order. Controlled medicines are separate again, since imports of dangerous drugs for medical use are licensed by Cabinet under the Illicit Drugs Control Act 2004.
Quality Systems Behind Every Sterile Injectable We Ship to Nauru
Farbe Firma manufactures under WHO-GMP certification in Gujarat, India, with ISO Class 5 aseptic filling zones under continuous environmental monitoring. Every batch is released against the compendium the buyer names, whether IP, BP, USP or EP, with testing by HPLC, GC, Karl Fischer, LAL endotoxin, sterility and particulate matter, and each shipment travels with the batch certificate that Nauru's Customs officers are required to see.
Stability studies follow ICH Q1A, with photostability under ICH Q1B where needed, and are designed for hot and humid storage, which matters on a remote equatorial island with long supply lines. Container-closure integrity is verified. Dossiers are prepared in CTD and ACTD format, and a WHO-format Certificate of Pharmaceutical Product and a free-sale certificate from the Indian regulator can be provided on request to support the permit application.
Why Farbe Firma is the Trusted Injectable Manufacturer in Nauru for Global Buyers
Farbe Firma is a WHO-GMP certified sterile injectable manufacturer and CDMO in Gujarat, India, exporting to more than 30 countries. In Nauru the route that matters is the Department of Health and Medical Services, whose Secretary is responsible for procuring medicines and vaccines and may do so notwithstanding the general public finance rules. We support those purchases with complete documentation, realistic shelf life and consolidated shipments sized to a small hospital's consumption rather than a large minimum order.
We are also careful about what Nauru law does not say. It does not name Australia's Therapeutic Goods Administration or any other single regulator; Australia is one approved country among fourteen. It does not yet set a labelling-language rule, although regulations on labelling may be made under the Act, so we label in English with the generic name, strength, batch number and expiry date as standard. And we found no evidence of pooled Pacific medicines purchasing for Nauru, so we plan around direct Government orders.
Two further facts shape planning. WHO's current listing records India's CDSCO at maturity level 3 with a scope of vaccines, and it is not a WHO-Listed Authority, so Nauru's approved-country list, rather than a WHO designation, is what opens the door for an Indian product. And the customs tariff as consolidated in 2024 applies no import duty to medicaments under headings 3002 to 3004, subject to any later change. The Essential Medicines List first adopted in 2011 and the 2014 treatment guidelines remain useful references for what the hospital stocks.
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Frequently Asked Questions (FAQ)
Can Indian-made injectables be imported into Nauru?
Yes, in principle. The Pharmacy Act 2025 lists India among the approved countries in Schedule 3. A medicine must be manufactured in and eligible for sale in an approved country, and each import needs a permit from the Secretary for Health and Medical Services. The Minister can amend the list by Gazette notice, so we check it before every supply.
Does Nauru require Australian TGA approval?
No. Nauru law does not refer to the TGA. Australia is one of fourteen approved countries, alongside India, New Zealand, Fiji, the United Kingdom, the United States and others. What the permit process requires is certified documentation from the regulator of the country where the medicine was made.
Who buys sterile injectables in Nauru?
Mainly the Government, through the Department of Health and Medical Services and the Government pharmacy at the Republic of Nauru Hospital. Under the Health and Medical Services Act 2025 the Secretary is responsible for procuring medicines and vaccines. A licensed private pharmacy could also import under the Pharmacy Act, but the Government has said none had yet been established.
Is there a medicines register in Nauru?
The Pharmacy Act 2025 requires the Secretary to keep a register of approved products in four classes, from general sale to narcotics, and to publish it in the Gazette each January and July. We have not yet found a published edition, so we confirm each product's status with the Department before quoting.
Can Global Fund or Gavi money be used to supply Nauru?
No. The World Bank classifies Nauru as high income, it does not appear on the Global Fund's 2026 eligibility list, and it is not eligible for Gavi support. Supply is planned around the Government's own orders and budget 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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