Gemcitabine injection — Indian WHO-GMP supply for pancreatic, NSCLC, bladder and ovarian cancer chemotherapy.

200mg, 1g (1000mg), 1.4g (1400mg) and 2g (2000mg) lyophilised vials. Reconstitute with 0.9% NaCl preservative-free (5 ml for 200mg, 25 ml for 1g, 35 ml for 1.4g, 50 ml for 2g) to a 38 mg/ml stock; further dilute to ≥0.1 mg/ml in 0.9% NaCl for 30-minute IV infusion. 1g and 1.4g are the high-volume tender lines for adult pancreatic, NSCLC, bladder and ovarian schedules at 1000-1250 mg/m² doses. 200mg covers paediatric off-label oncology and small-vial dose-banded protocols. 2g supports high-BSA dosing in centralised aseptic compounding units. Do NOT refrigerate the lyophilised vial or reconstituted solution — refrigeration causes irreversible crystallisation.

No — gemcitabine is not listed under the WHO Prequalification programme. The WHO PQ scope covers selected priority disease areas (HIV, TB, malaria, reproductive health, neglected tropical diseases) and does not currently include oncology cytotoxics. Gemcitabine is procured for international tender qualification under SRA-reliance pathways (drawing on EMA, MHRA, FDA, TGA and Health Canada approved-generic reference dossiers) and stringent-regulatory-authority equivalence rather than WHO PQ. M Care prepares SRA-reliance reference dossiers for accelerated registration in SRA-recognising African, GCC and Latin American markets, alongside full CTD Module 3 chemistry, manufacturing and controls documentation.

Inadvertent refrigeration of the lyophilised vial or the reconstituted solution is the single most common gemcitabine dispensing error globally — refrigeration causes crystallisation that does not redissolve on warming, rendering the vial unusable and consuming both the cost of the vial and a chemotherapy day-unit slot. Our destination-language pack inserts and SmPCs carry an explicit 15-30°C storage statement, the contraindication against refrigeration on both the outer carton and the vial label, and a reinforcing line in the reconstitution and dilution instructions section. The receiving aseptic compounding unit responsibility (training pharmacy assistants on the do-not-refrigerate rule) sits with the dispensing pharmacy; the manufacturer-side responsibility (clear, unambiguous labelling) is ours.

The UK (NHS oncology day-unit and aseptic compounding unit supply, or named-patient / MHRA Specials route during shortage), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers — tertiary cancer centre and oncology formulary tenders are the main channels — sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda) for tender and teaching-hospital cancer-centre supply with SRA-reliance pathway support. 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, pH on reconstitution, sterility, bacterial endotoxin, particulate matter), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate with cytotoxic-dedicated facility annexure, manufacturing licence with anticancer schedule, Certificate of Origin (chamber-attested), destination-language pack insert with refrigeration-contraindication reinforcement + cytotoxic warning iconography + pulmonary toxicity / HUS / radiation-recall prescribing information, cytotoxic chain-of-custody seal verification documentation, plus temperature logs (with both high-end and low-end excursion monitoring) 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. Gemcitabine has a well-established CMC template — lead time on a dossier against a new registration is typically 4-6 weeks from NDA signature, with the cytotoxic-dedicated facility cleaning validation and operator-exposure containment annexures adding the additional review time over a non-cytotoxic generic. SRA-reliance reference dossier prepared separately for accelerated registration in SRA-recognising markets. See dossier preparation.

For registered markets with stock on hand, dispatch is typically 7-12 working days from confirmed order. For tender awards (NUPCO, KEMSA, CMS Ghana, EPSS, MSD Tanzania, NMS Uganda), the lead time is set in the tender award document. For UK NHS oncology day-unit ad-hoc supply with urgency flagged, air-freight out of Mumbai can be on a flight within 72-96 hours. Made-to-order batches run 8-12 weeks inclusive of QC release, cytotoxic-dedicated suite turnaround and destination artwork. Gemcitabine lyophilised vial must not be refrigerated in transit or storage — it ships at 15-30°C ambient with active low-end excursion monitoring (refrigeration-contraindicated, the alarm is set at 10°C low-end in addition to the standard high-end). Reconstituted solution at the hospital end is also stored at 20-25°C, not refrigerated. Transit temperature is logged on every consignment for QA traceability and cytotoxic chain-of-custody verification.