Azithromycin — Indian WHO-GMP supply for CAP, AECOPD, trachoma MDA and pertussis prophylaxis.

250mg and 500mg film-coated tablets in Alu-Alu or Alu-PVC blister, in Z-pak 6-tablet (500mg day 1 then 250mg days 2-5), 3-tablet (500mg OD x 3 days), and hospital 100-tablet packs. 200mg/5ml powder for oral suspension in HDPE bottle with reconstitution graduations and a paediatric dosing syringe — reconstitute with water at point of dispensing, stable 5 days at room temperature. 500mg lyophilised IV vial for hospitalised CAP, severe Legionella and IV-to-oral switch protocols. Reconstitute IV with 4.8ml sterile water for injection, dilute to 1-2 mg/ml in 0.9% NaCl or 5% glucose, slow infusion ≥60 minutes (do not bolus).

Yes. Multiple M Care partner facilities hold WHO Prequalification for azithromycin tablets, oral suspension and IV. The WHO PQ certificate is included in the shipping documentation pack. Azithromycin is the WHO-recommended single agent for trachoma mass drug administration under the WHO GET2030 elimination programme — annual MDA campaigns reach ≈100 million people across 40+ endemic countries. We engage on WHO/ITI trachoma MDA pooled tenders, country-level public-sector tenders (KEMSA, NAFDAC, CMS Ghana, EPSS, MSD Tanzania, NMS Uganda), Global Fund cholera-outbreak adjunct grants, and NGO procurement (MSF, Direct Relief, Partners In Health) through the same manufacturing lines.

The FDA issued a black-box-equivalent safety communication in March 2013 after a NEJM cohort showed a small but statistically significant excess of cardiovascular death during 5-day Z-pak courses (relative risk ≈2.5 vs amoxicillin); the EMA followed with a 2013-2014 review. Our destination-language pack inserts and SmPCs carry the QT-prolongation warning, the contraindication in patients with known QT prolongation, hypokalaemia, hypomagnesaemia, bradyarrhythmia, congenital long-QT syndrome, or on Class IA / Class III antiarrhythmics, plus drug-interaction warnings for statins (rhabdomyolysis with simvastatin / atorvastatin / lovastatin), warfarin (INR rise at days 3-5), ergotamine (contraindicated), and colchicine (toxicity reported). The prescribing-side responsibility (ECG monitoring in at-risk patients) sits with the prescribing clinician; the manufacturer-side responsibility (clear labelling) is ours.

The UK (NHS primary-care and hospital pharmacy supply or named-patient / MHRA Specials route during shortage), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers — primary-care and paediatric oral-suspension tenders are the main channels — sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda) for tender, teaching-hospital supply, and WHO trachoma MDA campaigns with WHO PQ pathway support — Global Fund cholera-outbreak adjunct grants are an episodic 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, related substances per Ph.Eur./USP, water content by Karl Fischer for the dihydrate form, residual solvents per ICH Q3C, dissolution profile, pH on reconstitution for suspension and IV, microbial limits, bacterial endotoxin for IV, particulate matter), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, WHO Prequalification certificate where applicable, Certificate of Origin (chamber-attested), destination-language pack insert with QT-prolongation cardiac warning + drug-interaction warnings (statins, warfarin, ergotamine, colchicine) + AWaRe Watch antibiotic stewardship label + paediatric mg/kg dosing chart (10 mg/kg day 1, 5 mg/kg/day x 4 days) on the suspension carton, Antimicrobial Stewardship Programme documentation for hospital pharmacy committee approval, plus temperature 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. Azithromycin has a well-established CMC template across tablets, oral suspension and IV — lead time on a dossier against a new registration is typically 3-5 weeks from NDA signature. WHO PQ dossier prepared separately for Global Fund, Africa CDC, and WHO trachoma MDA qualification. AWaRe Watch 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 (WHO trachoma MDA, Global Fund cholera-outbreak adjunct, Africa CDC, NUPCO, KEMSA, CMS Ghana), the lead time is set in the tender award document. For UK NHS primary-care or 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 6-10 weeks inclusive of QC release and destination artwork. Azithromycin tablets, oral-suspension powder and lyophilised IV vial do not require cold-chain in transit — they ship at 15-30°C ambient. Reconstituted oral suspension is stable for 5 days at room temperature (do not refrigerate — palatability drops); reconstituted IV stable 24 hours at room temperature. Transit temperature is logged on every consignment for QA traceability.