Amoxicillin-clavulanate (co-amoxiclav) — Indian WHO-GMP supply for CAP, otitis media, sinusitis, cellulitis and bite-wound prophylaxis.

Tablets: 375mg (250/125), 625mg (500/125) and 1000mg (875/125). 625mg TDS and 1000mg BD are the global adult primary-care workhorses; 1000mg TDS is the high-dose protocol for severe sinusitis or dental abscess. Paediatric suspensions: 156.25mg/5ml (4:1 ratio, younger children), 228.5mg/5ml (7:1), 312.5mg/5ml (7:1), and 457mg/5ml (7:1, designed for high-dose 80-90 mg/kg/day otitis media protocols where clavulanate exposure must stay proportionate). IV vials: 1.2g (1000mg amoxicillin + 200mg clavulanate). Reconstituted suspension must be refrigerated at 2-8°C and discarded after 7 days — clavulanate hydrolyses in aqueous solution. Reconstituted IV use within 20 minutes; do not dilute IV in 5% glucose.

Yes. Multiple M Care partner facilities hold WHO Prequalification for amoxicillin/clavulanic acid combinations, particularly paediatric suspensions and dispersible tablets. The WHO PQ certificate is included in the shipping documentation pack. Co-amoxiclav is one of the highest-volume oral antibiotics in Global Fund pooled procurement for paediatric care — IMCI protocols, PEPFAR-aligned paediatric pneumonia programmes and Africa CDC AMR Stewardship initiatives. We engage on Global Fund pooled tenders, country-level public-sector tenders (KEMSA, NAFDAC, CMS Ghana, EPSS, MSD Tanzania, NMS Uganda) and NGO procurement (MSF, Direct Relief, Partners In Health) through the same manufacturing lines.

Clavulanate-driven cholestatic hepatitis occurs at approximately 1 in 25,000 courses, rising with age, male sex and treatment courses longer than 14 days. Onset is typically 1-6 weeks after the course finishes. EMA, MHRA, FDA, ANSM and SFDA all mandate explicit hepatic-injury warnings on co-amoxiclav labelling. Our destination-language pack inserts and SmPCs carry the warning, the contraindication for prior co-amoxiclav-related jaundice/hepatic dysfunction (rechallenge is contraindicated), and the 14-day course-length guidance. Penicillin-allergy and cephalosporin cross-reactivity warnings (1-2% true cross-reactivity in contemporary structure-based data; severe penicillin allergy contraindicates co-amoxiclav) are also set out.

The UK (NHS primary care plus hospital pharmacy supply, or named-patient / MHRA Specials route during shortage), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers — paediatric formulary and primary-care tenders are the main channels — sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda) for tender and teaching-hospital supply with WHO PQ pathway support — Global Fund paediatric pneumonia and IMCI grants are a high-volume channel. Egypt, Jordan, Iraq on the Levant side. Germany under §72 AMG, France under ANSM-equivalent route, Brazil (ANVISA), Mexico (COFEPRIS) and the Philippines (FDA Philippines). We do not supply into India. Full market coverage is at markets.

Every consignment ships with a batch-specific Certificate of Analysis (HPLC assay for both amoxicillin and clavulanate, related substances per Ph.Eur./USP, water content by Karl Fischer, dissolution, content uniformity, microbial limits; for IV vials sterility, bacterial endotoxin, particulate matter, pH on reconstitution), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, WHO Prequalification certificate where applicable (paediatric suspensions and dispersible tablets), Certificate of Origin (chamber-attested), destination-language pack insert with clavulanate hepatitis warning + paediatric suspension reconstitution and cold-chain instructions + AWaRe Access antibiotic stewardship label, Antimicrobial Stewardship Programme documentation for hospital pharmacy committee approval, plus temperature and humidity logs from pre-dispatch through on-arrival. PV contact nominated on registration.

Yes. Full CTD Module 3 dossiers are available against a non-disclosure agreement, for registration with MHRA, GCC central registration, SFDA, MoHAP, NAFDAC, PPB, SAHPRA, EFDA, TMDA, NDA, BfArM, ANSM, ANVISA, COFEPRIS, FDA Philippines and comparable bodies. Module 2 summaries and Module 1 administrative sections are prepared in destination-specific format. Co-amoxiclav has a well-established CMC template — lead time on a dossier against a new registration is typically 4-6 weeks from NDA signature (slightly longer than single-API antibiotics because clavulanate stability data sets must be reviewed in parallel). WHO PQ dossier prepared separately for Global Fund and Africa CDC qualification — paediatric suspensions and dispersible tablets carry the established WHO PQ template. AWaRe Access antimicrobial stewardship documentation prepared as a CTD addendum. See dossier preparation.

For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. For tender awards (Global Fund, Africa CDC, NUPCO, KEMSA, CMS Ghana), the lead time is set in the tender award document. For UK NHS hospital pharmacy ad-hoc supply with urgency flagged, air-freight out of Mumbai can be on a flight within 72 hours. Made-to-order batches run 8-12 weeks inclusive of QC release and destination artwork. Tablets and IV vials ship at 15-25°C ambient with humidity control (clavulanate is moisture-sensitive — foil/aluminium blister plus desiccant for tropical destinations). Suspension powder ships at ambient pre-reconstitution. Cold-chain only kicks in at the patient end after reconstitution: the reconstituted suspension is stable for 7 days at 2-8°C and must be discarded thereafter. Reconstitution and cold-chain instructions are printed on the bottle label and patient leaflet in destination language. Transit temperature and humidity are logged on every consignment for QA traceability.