Chloramphenicol Exporter for Ophthalmic, Topical and Systemic-Restricted Markets
Chloramphenicol occupies a regulatory position unlike any other molecule in this catalogue: a rare, dose-independent risk of aplastic anaemia has pushed systemic (oral and injectable) use out of routine practice in most high-income markets, even as the injectable form stays on the WHO Essential Medicines List as a second-choice option for bacterial meningitis in low-resource settings, and its topical/ophthalmic forms remain unremarkable, widely used treatments almost everywhere. Oral chloramphenicol also remains in use for typhoid fever in some resource-limited settings where safer alternatives are unavailable, separately from its meningitis listing. M Care supplies across this full format range, sourced from WHO-GMP certified Indian manufacturers.
Chloramphenicol exporter and bulk supplier from India.
M Care's chloramphenicol catalogue spans 28 product lines across topical/ophthalmic (eye drops and eye ointment), oral (capsule and oral suspension) and injectable (powder for injection) presentations, sourced from WHO-GMP certified Indian manufacturers, with export documentation built around each format's regulatory profile. Ophthalmic and topical lines move under standard pharmaceutical export paperwork: Certificate of Analysis, Certificate of Pharmaceutical Product, manufacturer's WHO-GMP certificate and free sale certificate. Oral and injectable (systemic) lines require the importer to confirm the destination country's own restriction or authorisation status before order confirmation, since several high-income regulators have withdrawn or tightly restricted systemic chloramphenicol, while the injectable form is retained by WHO as a second-choice option for bacterial meningitis in other markets. Cold-chain is not typically required; standard pharma packing with temperature monitoring on request. All shipments are supported by batch-specific CoA and manufacturer GMP documentation for customs and import registration. We quote ophthalmic and topical chloramphenicol into UK and EU destinations without qualification. Systemic capsules, oral suspension and the injection we quote only against a documented indication and an importer whose national regulator permits systemic use. Where a destination does not permit it, we say so rather than paper over the restriction.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Amphenicol antibacterial, bacteriostatic protein synthesis inhibitor (binds the bacterial 50S ribosomal subunit), sourced and documented for export.
Chloramphenicol is the one molecule in this catalogue with the sharpest regulatory-geography split of any product M Care carries, driven entirely by route of administration. Systemic (oral and injectable) chloramphenicol carries a rare, dose-independent risk of aplastic anaemia that has led most high-income regulators to withdraw or tightly restrict its systemic use, even as the injectable form remains on the WHO Essential Medicines List as a second-choice option for bacterial meningitis in resource-limited settings. Topical and ophthalmic chloramphenicol, by contrast, carry no established or consistently demonstrated systemic marrow risk at labelled topical exposure and remain in routine, largely unrestricted use worldwide, including over-the-counter sale for bacterial conjunctivitis in the UK. Pharmacologically, chloramphenicol is a broad-spectrum bacteriostatic antibiotic, a protein synthesis inhibitor that binds the bacterial 50S ribosomal subunit, active against a wide range of Gram-positive, Gram-negative, anaerobic and atypical organisms, and was historically first-line therapy for typhoid fever.
Active ingredient
Chloramphenicol (also supplied as chloramphenicol sodium succinate for injection and chloramphenicol palmitate for oral suspension). Amphenicol antibacterial, bacteriostatic protein synthesis inhibitor (binds the bacterial 50S ribosomal subunit).
Forms and strengths
250 mg capsule (oral); 500 mg capsule (oral); 0.5 % w/v (eye drops); 1 % w/w (eye ointment).
Indications
Chloramphenicol is a broad-spectrum bacteriostatic antibiotic that inhibits bacterial protein synthesis by binding the 50S ribosomal subunit. Systemic (oral and parenteral) use is restricted in most high-income regulatory markets because of a rare, dose-independent risk of aplastic anaemia; ophthalmic and topical use carries no established or consistently demonstrated systemic marrow risk at labelled exposure and remains in routine use in most jurisdictions.
Administration
Ophthalmic, Topical, Oral, Intravenous, Intramuscular. Available across multiple presentations: capsules (250 mg and 500 mg, oral), oral suspension, eye drops, eye ointment, and powder for injection for parenteral use..
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers fall into two distinct groups shaped by the same regulatory split this page leads on. Hospital procurement and tender desks in low- and middle-income markets across Africa, Southeast Asia and parts of Latin America order the injectable form of chloramphenicol for bacterial meningitis treatment, consistent with WHO's Essential Medicines List entry covering the parenteral formulations, and the oral capsule for typhoid fever and other systemic indications where local Salmonella Typhi susceptibility and drug access support it. Licensed importers and pharmacy chains across the UK, EU, Gulf/GCC and other higher-income markets order the topical/ophthalmic lines, where regulatory status is unremarkable and demand is steady for bacterial conjunctivitis treatment. Regulatory affairs teams in both groups typically request destination-specific documentation before confirming systemic orders, given the format-dependent restriction landscape.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on chloramphenicol.
A dispensing or clinical pharmacist reviewing a chloramphenicol order checks route first: ophthalmic and topical formats carry no established or consistently demonstrated systemic aplastic anaemia signal at labelled exposure and do not require routine haematological monitoring, while oral and injectable formats require baseline and periodic (commonly every 48 hours during systemic therapy) full blood count monitoring for both the common, reversible, dose-dependent marrow suppression and the rare, idiosyncratic, dose-independent aplastic anaemia. Neonatal and infant dosing carries a separate, distinct risk (grey baby syndrome, from immature hepatic glucuronidation and reduced renal clearance leading to drug accumulation) that a pharmacist checks against age and hepatic/renal function before systemic use in this population. Drug interaction review should flag chloramphenicol's inhibition of hepatic CYP enzymes, which raises plasma levels of phenytoin, warfarin and sulfonylureas. For typhoid indications, local Salmonella Typhi susceptibility data should be confirmed given documented chloramphenicol resistance in several endemic regions. Any systemic order into a market with specialist-authorisation requirements should be flagged for the importer's own regulatory sign-off before dispatch.
The documentation pack a regulator actually asks for.
Each chloramphenicol shipment is supported by a batch-specific Certificate of Analysis covering assay, related substances, sterility (for ophthalmic and injectable formats) and dissolution or particle size as applicable, plus the manufacturer's WHO-GMP certificate and a free sale certificate or Certificate of Pharmaceutical Product in WHO format for destination registration. Stability data is available on request and is particularly relevant for ophthalmic solutions and the oral palmitate suspension, both of which are photosensitive and temperature-sensitive. CTD/eCTD Module 3 quality documentation (drug substance and drug product sections) can be compiled to support new marketing authorisation applications. Because systemic chloramphenicol faces tighter regulatory status in several destination markets, M Care recommends importers confirm current national scheduling, specialist-authorisation or formulary-restriction requirements with their own regulatory affairs function before order confirmation; M Care does not issue destination-market regulatory opinions. No controlled-drug permits apply to chloramphenicol, but its restricted-use status in some jurisdictions means import licensing timelines can differ from unrestricted antibiotics, and buyers should build this into their registration planning. M Care itself holds ISO 9001:2015 certification and a CDSCO license and sources exclusively from WHO-GMP certified manufacturers.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Systemic (oral and injectable) chloramphenicol carries a boxed-warning-level risk of aplastic anaemia that is dose-independent and can occur after any course length or dose.
Oral chloramphenicol capsules and oral suspension have no currently approved marketing application in the United States; FDA has determined the prior approved oral products were withdrawn for reasons of safety.
In the UK, systemic chloramphenicol use requires authorisation from Infectious Diseases or Microbiology specialists and is reserved for cases where safer antibacterials are unsuitable, with blood monitoring recommended roughly every two days during treatment.
Chloramphenicol remains on the WHO Essential Medicines List as a second-choice option for bacterial meningitis; the 2023 update retained only the parenteral formulations (IV and IM), with the IM oily suspension restricted to presumptive treatment of epidemic meningitis in children older than 2 years and in adults, and deleted the oral capsule and oral liquid formulations from the list.
Ophthalmic chloramphenicol has no established or consistently demonstrated systemic aplastic anaemia signal at labelled topical exposure and is available over the counter in the UK for bacterial conjunctivitis; regulatory treatment of ophthalmic chloramphenicol differs by country and importers must verify local status.
Chloramphenicol is a prohibited substance in food-producing animals in the EU with no permitted maximum residue limit; this restriction applies to veterinary/food-chain use, not directly to human pharmaceutical formulations, but buyers in mixed-use supply chains should be aware of it.
Adjacent lines procurement desks order alongside chloramphenicol.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for chloramphenicol.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Chloramphenicol supply, the specific questions.
Is chloramphenicol still legally sold and prescribed anywhere, given the aplastic anaemia risk?
Yes, but the picture depends entirely on route. Systemic (oral, injectable) chloramphenicol has been withdrawn from routine sale in the United States and is restricted to specialist-authorised use in the UK and similar markets, while the injectable form remains on the WHO Essential Medicines List as a second-choice option for bacterial meningitis (the 2023 update to the list deleted the oral capsule and oral liquid entries, retaining only the parenteral formulations), and the oral capsule is still used for typhoid in settings where safer alternatives are unavailable or resistance patterns favour it. Ophthalmic and topical formulations are unrestricted in most countries and sold over the counter in the UK.
What causes the aplastic anaemia risk, and is it dose-related?
No, it is not dose-related. Chloramphenicol causes two distinct blood effects: a common, reversible, dose-dependent bone marrow suppression, and a rare, idiosyncratic, dose-independent aplastic anaemia thought to involve toxic or immune-mediated injury to marrow stem cells, occurring in roughly 1 in 24,000 to 40,000 treatment courses regardless of dose or duration. This is the reason systemic use is restricted rather than simply dose-capped. Unlike a dose-dependent hepatotoxicity that a prescriber can monitor around with baseline liver function tests, chloramphenicol marrow aplasia is idiosyncratic and dose-independent. There is no monitoring protocol that makes systemic use safe, which is why high-income regulators withdrew it rather than restricting it.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care is a merchant-exporter, not a manufacturer, and does not hold WHO-GMP or WHO-PQ certification directly. M Care sources chloramphenicol lines from WHO-GMP certified Indian manufacturers and holds its own ISO 9001:2015 certification and CDSCO license for its export operations. Manufacturer GMP certificates are supplied with every shipment.
Which chloramphenicol formats can M Care supply?
M Care's chloramphenicol catalogue comprises 28 product lines spanning topical/ophthalmic (eye drops and eye ointment), oral (capsule and oral suspension) and injectable (powder for injection) presentations, sourced from WHO-GMP certified Indian manufacturers. Buyers should confirm which formats are registrable in their destination market before order confirmation, since systemic formats face tighter regulatory status in some jurisdictions than others.
Can chloramphenicol be imported into the UK, EU or Gulf markets for hospital use?
Ophthalmic and topical chloramphenicol are importable in most of these markets under standard pharmaceutical registration. Systemic (oral or injectable) chloramphenicol is subject to national restrictions in several of these jurisdictions, where its use is typically confined to specialist-authorised, hospital settings when safer alternatives are unsuitable. Importers should confirm current national formulary and registration status with their own regulatory affairs team before placing a systemic order.
Is chloramphenicol still used for typhoid fever?
Chloramphenicol was historically the first-line treatment for typhoid fever and remains in use in resource-limited settings, particularly where fluoroquinolones, third-generation cephalosporins or azithromycin are unavailable, unaffordable, or where local Salmonella Typhi susceptibility testing supports its use. WHO guidance now favours other agents as first-line where available, reserving chloramphenicol for settings with limited alternatives or confirmed susceptibility.
What documentation does M Care provide with each chloramphenicol shipment?
Every shipment is accompanied by a batch-specific Certificate of Analysis, the manufacturer's WHO-GMP certificate, a Certificate of Pharmaceutical Product or free sale certificate as required by the destination regulator, and supporting stability data where requested. Buyers handling systemic formats should also request documentation confirming the manufacturer's compliance with any destination-specific monitoring or labelling requirements.
Why does chloramphenicol still appear on the WHO Essential Medicines List if it causes aplastic anaemia?
WHO's Essential Medicines List balances risk against therapeutic necessity in the settings the list serves. For bacterial meningitis in resource-limited settings, the injectable form of chloramphenicol remains listed as a second-choice option where first-choice agents such as cefotaxime or ceftriaxone are unavailable; the list's 2023 update retained only the parenteral formulations and removed the oral capsule and oral liquid entries. The aplastic anaemia risk, while serious, is rare, and is weighed against the near-certainty of harm from untreated severe bacterial infection in settings where alternatives are inaccessible. This is a different risk calculus than in markets with ready access to safer alternatives, which is why the regulatory treatment diverges so sharply by geography.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
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