Why Farbe Firma is the Leading Injectable Manufacturer in Dominica
Why Farbe Firma is the Leading Injectable Manufacturer in Dominica
Last Updated: 24 September 2026
TL;DR: The Commonwealth of Dominica - not to be confused with the Dominican Republic - brought a new Pharmacy Act into operation in October 2025. It registers pharmacists and pharmacy premises rather than products, and names no foreign regulator, so India's CDSCO is neither recognised nor excluded there. The Act expressly leaves pooled OECS procurement outside the new Pharmacy Council's remit, and on the Ministry of Health's 2011 figures that route carried about 95% of public-sector medicines. A 1958 Antibiotics Act separately approves manufacturing firms one by one.
Key Takeaways
The Pharmacy Act, 2024 (Act No. 11 of 2024) was brought into operation from October 2025 by a ministerial commencement order. It creates a Dominica Pharmacy Council and defines its registers as two: pharmacists and pharmacies. We found no provision creating a national register of medicinal products, and no provision naming any foreign regulatory authority.
The same Act states that nothing in it gives the Council responsibility over any activity for which the OECS Pharmaceutical Procurement Service is responsible. Public-sector supply therefore continues through pooled regional procurement, which on the Ministry's own 2011 figures carried roughly 95% of government pharmaceutical purchases, with Central Medical Stores handling national distribution.
The Act allows regulations on the importation and wholesale of drugs, but we have not located any. Until they appear, the private-market gateway is a pharmacy registered with the Council and run under the direct supervision of a licensed pharmacist, which in practice means an overseas manufacturer works through a Dominican partner rather than importing in its own name.
A 1958 Antibiotics Act still on the statute book allows the antibiotics it covers to be imported only under licence and only if made by a firm the Minister has approved, with approved firms to be published in the Gazette. Approval turns on the firm holding a manufacturing licence in its own country, not on which country's regulator issued it.
Introduction: Why an Injectable Manufacturer in Dominica Needs to Read the New Law Closely
Dominica is easy to underestimate. With a population well under a hundred thousand, the island is sometimes treated as a market where medicines move on goodwill and paperwork follows later. That picture is now out of date. A new Pharmacy Act was assented to in December 2024 and brought into operation from October 2025, alongside a regime that has relied since the 1930s on the Medical Act's provisions for chemists and druggists, which stay on the statute book until a separate 2026 Act repealing them is brought into force.
The new law matters as much for what it leaves alone as for what it builds. It builds a Dominica Pharmacy Council, a register of pharmacists and a register of pharmacy premises. It does not build a register of products, and it names no foreign regulator at all. It also draws an explicit boundary around the regional pooled-procurement service, which remains the main channel for public-sector medicines. For an exporter, that combination decides where the real work lies.
What Sets a World-Class Injectable Manufacturer in Dominica's Supply Chain Apart
The first discipline is keeping three layers apart. At the site layer, we found no Dominican power to inspect or license a factory abroad; the Pharmacy Act's inspection powers run to premises in Dominica. At the product layer there is no register, and the Ministry's own 2011 survey answer was that products are not registered in Dominica. At the importer layer the requirement is local and concrete: a registered pharmacy under a licensed pharmacist, or the public channel.
The one place Dominican law looks at the manufacturer directly is the Antibiotics Act of 1958. Its definition lists penicillin, streptomycin, aureomycin and chloromycetin and lets the Minister add more by order; we found no such order, and whether a given modern anti-infective falls inside it is for the Dominican authorities, not for us, to decide. Where it does apply, the approved-firm test and a separate import licence both bite, so we raise the question before a first shipment rather than after.
Quality Systems Behind Every Batch Bound for the Eastern Caribbean
Farbe Firma manufactures under WHO-GMP certification in Gujarat, India, with ISO Class 5 aseptic filling zones under continuous environmental monitoring. Dominican law sets no closed list of pharmacopoeias - the British Pharmacopoeia appears only as a dispensing-dose reference - so we write specifications to the compendium the buyer or tender names. Release testing covers HPLC and GC assay and impurities, Karl Fischer, LAL endotoxin, sterility, particulate matter and container-closure integrity.
Dominica has no national quality-control laboratory; CARICOM states can send samples to the Caribbean Regional Drug Testing Laboratory in Jamaica, so documentary quality has to be complete on arrival. Stability studies follow ICH Q1A, with photostability under ICH Q1B where the molecule requires it, and are designed for hot, humid tropical storage. Remaining shelf life at delivery is planned against long freight routes, and dossiers are prepared in CTD and ACTD format.
Why Farbe Firma is the Trusted Injectable Manufacturer in Dominica for Global Buyers
Farbe Firma is a WHO-GMP certified sterile injectable manufacturer and CDMO in Gujarat, India, exporting to more than 30 countries. What a Dominican buyer needs is a supplier whose documents fit the channel actually in use. The OECS Pharmaceutical Procurement Service prequalification form asks a manufacturer to attach a certificate of GMP or ISO certification, names no issuing authority, treats a WHO-format Certificate of Pharmaceutical Product as optional, and routes new manufacturers through an authorised distributor.
We are equally direct about where an Indian approval does less work. CARPHA's Caribbean Regulatory System issues recommendations rather than registrations, and its published lists of reference authorities do not include CDSCO; we found no Dominican instrument referring to it at all. That is not a closed door: on CARPHA's recommended list as last published in November 2022, 162 of 286 entries were issued to Indian addresses, 85 of them injectables, reaching it through other reference authorities or WHO Prequalification.
Two further points are worth stating plainly. WHO's current listing records CDSCO at maturity level 3 with a scope of vaccines, whereas Ghana, Nigeria and Tanzania carry medicines, so a maturity-level argument does no work for a small-molecule injectable. On funding, Dominica is upper-middle income with blend lending status and is eligible on the Global Fund's 2026 list for HIV and tuberculosis, but the Caribbean multi-country HIV channel is in its final cycle. Eligibility is not an allocation.
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Frequently Asked Questions (FAQ)
Does Dominica register medicines before they can be sold?
On everything we have read, no. The Pharmacy Act, 2024 defines its registers as the register of pharmacists and the register of pharmacies, and creates no register of products. The Ministry of Health's 2011 survey answer, published with PAHO, was that products are not registered in Dominica. The Act does allow future regulations on importation and wholesale, so check with the Ministry before each new product launch.
Is India's CDSCO recognised in Dominica?
The question does not currently arise under Dominican law. We found no Dominican instrument that names any foreign regulatory authority, so we describe CDSCO as neither recognised nor excluded there. Regulator lists appear only at the regional level, in CARPHA's Caribbean Regulatory System, whose reference lists do not include CDSCO and whose output is a recommendation rather than a registration.
How does the public sector buy injectables in Dominica?
Mainly through the OECS Pharmaceutical Procurement Service, which the Pharmacy Act expressly places outside the Pharmacy Council's responsibility. On the Ministry's 2011 figures about 95% of public-sector pharmaceuticals were procured that way, with Central Medical Stores managing distribution. Suppliers are prequalified, and the form asks for a certificate of GMP or ISO certification without naming an issuing authority.
Does the Antibiotics Act affect injectable anti-infectives?
It may. The 1958 Act allows the antibiotics it covers to be imported only under licence and only if made by a firm the Minister has approved, on proof that the firm is licensed to manufacture in its own country. Its definition is a 1950s list that the Minister can extend by order, so whether a specific modern molecule is caught is for the Dominican authorities to confirm.
Is donor funding a route for injectables in Dominica?
Only narrowly. Dominica is eligible on the Global Fund's 2026 list for HIV and tuberculosis, not malaria, and the Caribbean multi-country HIV component that names it is on a final-cycle transition timeline, with grants ending no later than 31 December 2030. Gavi lists Dominica among countries never eligible for its support. For generic sterile injectables, the buyer that matters is the Government itself.
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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