Levothyroxine sodium — Indian WHO-GMP supply for primary, congenital and post-thyroidectomy hypothyroidism.

25mcg, 50mcg, 75mcg, 100mcg, 125mcg, 150mcg and 200mcg film-coated tablets covering the full titration range and paediatric weight-based dosing. 25mcg/5mL paediatric oral solution in amber glass bottle with calibrated oral syringe — the WHO-recommended formulation for congenital hypothyroidism and infants who cannot swallow tablets. 100mcg lyophilised IV vial for myxoedema coma in ICU and for surgical patients NPO peri-operatively (reconstitute with 5mL 0.9% NaCl). Tablets pack in aluminium-aluminium blister or HDPE bottle with silica-gel desiccant — moisture exclusion is the formulation-stability priority because levothyroxine degradation accelerates with humidity.

Levothyroxine is classified as a Narrow Therapeutic Index (NTI) drug by FDA, MHRA and EMA — small AUC and Cmax differences within standard ±20% bioequivalence limits shift TSH and clinical state, which is why cross-brand switching in stable patients is discouraged by MHRA Drug Safety Update 2021 and FDA NTI guidance. Our CTD dossier carries a tighter NTI-drug bioequivalence package (95-105% AUC and Cmax limits per Ph.Eur. and FDA NTI guidance, vs the non-NTI 90-110% norm). Pack labelling carries the brand-switching caution prominently, and where a hospital pharmacy committee or chronic prescription channel needs to standardise on a single brand, we can support that continuity. If a brand switch is unavoidable, the clinical recommendation is to recheck TSH 6-8 weeks after switch and counsel the patient on over- / under-replacement symptoms — that counselling material is included with each consignment.

Yes. Multiple M Care partner facilities hold WHO Prequalification for the paediatric oral solution (25mcg/5mL) and selected tablet strengths qualified for African public-sector neonatal-screening programmes. The WHO PQ certificate is included in the shipping documentation pack. Congenital hypothyroidism is a priority WHO MNCH (Maternal, Newborn and Child Health) target — neurodevelopmental outcome correlates tightly with how fast euthyroidism is restored after neonatal screening pickup, which is why initiation within 2 weeks of birth at 10-15 mcg/kg/day is the standard. We engage on 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 WHO PQ-listed manufacturing lines.

The UK (NHS chronic prescription supply or named-patient / MHRA Specials route during recurring 2022-2025 shortage notices), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers — endocrinology clinic supply and neonatal screening programme 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, particularly for paediatric formulations. 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). M Care does not hold FDA or TGA registrations, so the United States and Australia are not served. We do not supply into India. Full market coverage is at markets.

Every consignment ships with a batch-specific Certificate of Analysis (HPLC assay 95-105% per Ph.Eur. NTI-tighter limits, related substances including liothyronine T3 and deiodinated impurities, water content by Karl Fischer, uniformity of dosage units, dissolution, microbial limits, residual solvents), Method of Analysis with stability-indicating method validation, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, WHO Prequalification certificate where applicable (paediatric formulations particularly), Certificate of Origin (chamber-attested), destination-language pack insert with NTI brand-switching warning, empty-stomach administration instruction, pregnancy dose-increase counselling and storage humidity warning, 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. NTI-drug bioequivalence package documented per FDA, MHRA and EMA guidance with tighter Cmax and AUC equivalence limits than non-NTI generics. Levothyroxine 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 non-NTI molecules because of the additional bioequivalence narrative. WHO PQ dossier prepared separately for paediatric formulation qualification. M Care does not hold FDA or TGA registrations. See dossier preparation.

For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. For chronic NHS prescription supply with continuity guarantee, we hold rolling stock against a forecast. For tender awards (NUPCO, KEMSA, CMS Ghana, EPSS), the lead time is set in the tender award document. For UK NHS hospital pharmacy ad-hoc supply during MHRA shortage notices 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. Levothyroxine tablets and oral solution do not require cold-chain in transit — they ship at 15-25°C ambient. Humidity is the stability priority, not temperature, so packaging excludes moisture by design (aluminium-aluminium blister, silica-gel-bearing HDPE bottle) and we run humidity logging on tropical-route consignments. Cold-chain only applies to the reconstituted IV product at the hospital end (2-8°C, use within 4 hours). Transit conditions are logged on every consignment for QA traceability.