Amikacin Sulphate Injection Exporter and Supplier
You are sourcing an amikacin sulphate injection line that clears audit at your health ministry and holds cold-chain-free stability across a long sea freight. M Care Exports supplies amikacin 100mg, 250mg, 500mg and 1g vials from Indian manufacturing lines for importers, distributors and hospital tender buyers across the UK, EU, GCC, Africa, Latin America and South-East Asia. As a merchant-exporter trading since 2003, we consolidate the dossier and shipping paperwork alongside your registration, not on your behalf.
Why buyers route amikacin volume through M Care
Amikacin sits in a narrow but non-negotiable slot: the aminoglycoside a hospital reaches for when gentamicin resistance has already emerged, and the injectable a national TB programme stocks for confirmed MDR cases. Demand is steady rather than seasonal, and it is almost entirely institutional: ICUs, tertiary hospitals and central medical-store tenders. M Care is a wholesaler and merchant-exporter, not a manufacturer, so what we bring is sourcing breadth across qualified Indian lines and the document assembly that keeps a tender award from stalling.
Sourced from WHO-GMP-listed lines
We supply amikacin from manufacturing sites operating to WHO-GMP standards. The GMP and any WHO-PQ status belong to the manufacturer; M Care's own credential is ISO 9001:2015 for its trading operation.
Strength range held for mixed orders
100mg, 250mg, 500mg and 1g vials can be combined on one order so a hospital pharmacy and a paediatric ward draw from the same shipment. Batch minimums are set by the source manufacturer's batch-release quantity.
Tender documentation assembled
For central-procurement bids we compile the CTD dossier, Certificate of Pharmaceutical Product (CoPP) and batch records alongside your regulatory team, matched to the tender's format and language.
Export logistics handled end to end
Amikacin is heat-stable at controlled room temperature, so we ship without cold chain but with full stability data, CoA per batch and packing built for long-haul consolidation. Pricing is on request against your volume and destination.
Amikacin at a glance: form, strength and class
Active ingredient
Amikacin (as amikacin sulphate), a semi-synthetic aminoglycoside derived from kanamycin. Concentration-dependent bactericidal action against aerobic gram-negative bacilli.
Strengths stocked
100mg, 250mg, 500mg and 1g per vial. The 250mg/mL 2mL presentation (500mg vial) is the most requested hospital pack; paediatric wards draw the 100mg vial.
Formulation and handling
Sterile solution for intramuscular or intravenous use. Stored at controlled room temperature, no refrigeration required, which simplifies distribution into warm-climate markets.
ATC classification
J01GB06, aminoglycoside antibacterials for systemic use. Listed on the WHO Model List of Essential Medicines.
WHO AWaRe group
Access group in the WHO AWaRe (Access, Watch, Reserve) classification, reflecting its role as a first- or second-choice agent with a relatively narrow spectrum.
WHO MDR-TB grouping
Group C in the WHO consolidated guidelines on drug-resistant TB: an injectable reserved for longer regimens where susceptibility is confirmed and audiometry monitoring is in place.
Buyer segments we serve for amikacin
Amikacin buyers are institutional almost by definition. The prescription happens in an ICU or a TB programme, so the purchasing sits with hospital groups, importer-distributors holding the marketing authorisation, and government procurement bodies.
Importer-distributors
Partners holding or seeking the marketing authorisation in their market who need a consistent Indian source and a dossier that supports their registration file.
Hospital and ICU procurement
Tertiary and private hospital groups buying amikacin as their escalation aminoglycoside when gentamicin resistance is documented locally.
Government and NGO tenders
Central medical stores and TB programmes procuring injectable second-line agents against published specifications, where CoPP and CTD compliance decide the award.
Regional wholesalers
Multi-country distributors consolidating anti-infective ranges who want mixed-strength amikacin on a single shipment to cover both adult and paediatric demand.
Safety-critical profile buyers should know
Amikacin carries the two dose-limiting toxicities characteristic of aminoglycosides, and both matter to any buyer specifying it into a formulary. Nephrotoxicity is usually reversible and dose-dependent, but ototoxicity is not: cochlear damage (hearing loss) and vestibular damage (balance disturbance) can be permanent. This is why the WHO MDR-TB guidance ties its use to confirmed susceptibility and high-quality audiometry monitoring. Dosing is weight-based, and therapeutic drug monitoring of peak and trough concentrations is standard practice, with the modern once-daily extended-interval regimen intended to preserve efficacy while limiting toxicity.
Prescribers also watch for neuromuscular blockade, particularly alongside anaesthetics or neuromuscular-blocking agents, and for additive nephrotoxicity when combined with other nephrotoxic drugs. Any dosing figures on this page are reference context for procurement teams reviewing the molecule, not clinical instruction; prescribing and monitoring decisions rest with the treating clinician against the approved product information in the destination market.
Written for professional buyers and importers, not as medical advice. Prescribing decisions sit with the treating clinician and the approved label in your market.
Export and registration documents we provide
Registration and customs clearance for an injectable antibiotic turn on the paperwork being complete and internally consistent. We assemble the following alongside your regulatory team, sourced from the manufacturer where the document originates with them.
CTD dossier
Common Technical Document modules compiled for your market's registration pathway, drawn from the manufacturer's site data and formatted to the destination authority's requirements.
CoPP
Certificate of Pharmaceutical Product in WHO format, issued by the Indian licensing authority for the manufacturing site, the anchor document most import registrations require.
CoA and batch records
Certificate of Analysis per batch plus the batch manufacturing record, evidencing identity, assay, sterility and endotoxin results for the amikacin lot shipped.
Stability and shipping data
Long-term and accelerated stability data supporting controlled-room-temperature storage, with the packing list, invoice and export declarations for customs.
Molecules buyers source alongside Amikacin.
How ordering works.
- Send your specification Share strengths, quantities, destination market and whether the order is for a tender, a registration batch or routine stock. We confirm what the source manufacturer's batch minimum allows.
- Receive quotation and samples We return a price-on-request quotation with lead time, and arrange registration or evaluation samples with the manufacturer's documentation where you need them for your file.
- Dossier and order confirmation We compile the CTD, CoPP and supporting documents alongside your regulatory team, then confirm the batch, pack configuration and delivery terms.
- Production, QC and despatch The manufacturer releases the batch against CoA; we handle consolidation, export documentation and shipment to your port on the agreed Incoterms.
Amikacin supply, the specific questions.
Is amikacin an Access or a Watch antibiotic under WHO AWaRe?
Amikacin is classified in the Access group of the WHO AWaRe (Access, Watch, Reserve) classification. That places it among first- and second-choice antibiotics with a comparatively narrow spectrum and lower resistance-driving potential than Watch-group agents, which supports its stocking on essential-medicines and stewardship-aligned formularies.
How is amikacin used in MDR-TB treatment?
In the WHO consolidated guidelines on drug-resistant TB, amikacin sits in Group C, the injectable agents added to longer MDR/RR-TB regimens when Group A and B medicines cannot compose an adequate regimen. It is used only where drug-susceptibility testing confirms the isolate is susceptible and where audiometry monitoring for hearing loss can be assured.
Which amikacin strengths does M Care supply?
We supply amikacin sulphate injection in 100mg, 250mg, 500mg and 1g vials. The 500mg vial (250mg/mL, 2mL) is the most requested hospital presentation; the 100mg vial covers paediatric use. Strengths can be combined on a single order, with quantities set by the source manufacturer's batch-release minimum.
Does M Care hold WHO-GMP or WHO-PQ certification for amikacin?
No, and we are precise about this. WHO-GMP and any WHO-PQ status belong to the manufacturer whose line produces the amikacin. M Care Exports is a merchant-exporter and wholesaler; we supply from WHO-GMP-listed manufacturing sites, and our own credential is ISO 9001:2015 for our trading operation.
What documentation do you provide for registration and tenders?
We compile the CTD dossier, CoPP, per-batch Certificate of Analysis, batch manufacturing records and stability data alongside your regulatory team, formatted to the destination authority's requirements. For tenders we match the submission to the published specification and language.
Does amikacin need cold-chain shipping?
No. Amikacin sulphate injection is stable at controlled room temperature, so it ships without a cold chain, which simplifies distribution into warm-climate markets. We supply full stability data with each consignment to support customs and quality review.
Which reference brands correspond to amikacin?
Reference brands include Amikin (the originator) and Indian brands such as Mikacin, Amicin and Amitru, named here only as buyer-reference context. We supply generic amikacin sulphate injection from Indian manufacturing lines; the brand or pack presentation is agreed per order and per market.
Request an amikacin quotation
Tell us your strengths, quantities and destination market, and whether this is for a tender, a registration batch or routine stock. We will return a price-on-request quotation with lead time and the documentation plan for your market.