Itraconazole, Indian WHO-GMP capsule supply for systemic and superficial mycoses.

The M Care roster carries the 100mg capsule, 58 branded generic lines in total, supplied under Indian reference brands including Canditral, Candiforce, Itrazest, Itmac and Fungikem. Pack is Alu-Alu or Alu-PVC blister in hospital and retail formats. Continuous once- or twice-daily dosing covers systemic mycoses; onychomycosis of the fingernail instead uses an intermittent pulse pattern of one week on, three weeks off, repeated. Tell us the brand preference, blister type and volume and we route to the matching line.

Yes. Itraconazole was added to the WHO Model List of Essential Medicines in 2017 and reaffirmed on the 23rd edition (2023), specifically for chronic pulmonary aspergillosis, histoplasmosis, sporotrichosis, paracoccidioidomycosis, chromoblastomycosis and Talaromyces marneffei infection, a group of neglected and endemic fungal diseases with a real caseload across our African, Latin American and Southeast Asian markets. Beyond the WHO EML scope, itraconazole is separately FDA-recognised for blastomycosis, aspergillosis unsuitable for amphotericin B, and onychomycosis of the toenail. We map the relevant indication to the tender or formulary submission you're working from.

The FDA added a boxed warning in 2001 following case reports of new or worsening congestive heart failure, some fatal, linked to itraconazole's negative inotropic effect. The contraindication is absolute for onychomycosis in any patient with ventricular dysfunction or a history of congestive heart failure, a non-life-threatening indication where the risk is not justified. For serious systemic mycoses, the label frames it as a risk-benefit decision for the treating physician rather than a blanket contraindication. Our destination-language pack inserts and SmPCs carry both the absolute and the conditional wording, correctly separated.

Itraconazole is a potent CYP3A4 inhibitor. Co-administration with simvastatin, lovastatin, oral midazolam or triazolam, ergot alkaloids, cisapride, quinidine, dofetilide or pimozide is contraindicated on the label, largely because of the risk of serious effects from raised plasma levels of the interacting drug. This is a longer interaction list than most antibacterials on our anti-infectives roster carry, which is why we set it out in full on the destination-language pack insert rather than a summary line. The prescribing decision on managing or avoiding a specific interaction stays with the clinician.

Itraconazole capsule absorption depends on an acidic gastric environment and a fatty meal; proton-pump inhibitors, H2-blockers and antacids can all reduce how much of the dose actually absorbs if timing isn't managed. This is different from the cyclodextrin-based oral solution formulation (not part of our listing), which absorbs better on an empty stomach and does not need gastric acid. It doesn't change ordering, the 100mg capsule is the line we carry, but it's a counselling point worth keeping on the destination pack insert rather than assuming the dispensing pharmacy already knows the capsule-versus-solution difference.

The UK (NHS hospital antifungal formularies, or the named-patient / MHRA Specials route during shortage), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers for tertiary-hospital and dermatology-clinic demand, and sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda) for teaching-hospital tenders and WHO EML endemic-mycosis programmes, chromoblastomycosis and African histoplasmosis among them. Germany under section 72 AMG, France, Brazil (ANVISA, relevant to that market's documented sporotrichosis burden), Mexico (COFEPRIS) and the Philippines (FDA Philippines, relevant to regional Talaromyces marneffei caseload). We do not supply into India. Full market coverage is at markets.

Yes. Full CTD Module 3 dossiers are available against a non-disclosure agreement, for registration with the MHRA, GCC central registration, SFDA, MoHAP, NAFDAC, PPB, SAHPRA, EFDA, TMDA, NDA, BfArM, ANSM, ANVISA, COFEPRIS, FDA Philippines and comparable bodies, with WHO EML indication mapping as an addendum for endemic-mycosis tender submissions. Every consignment ships with a batch-specific Certificate of Analysis (HPLC assay, related substances, water content, dissolution profile), Method of Analysis, Certificate of Pharmaceutical Product, the manufacturing partner's WHO-GMP certificate, manufacturing licence, Certificate of Origin, and a destination-language pack insert carrying the heart-failure warning, the CYP3A4 interaction table and the food-and-acidity absorption note. M Care's own ISO 9001:2015 certification covers our export documentation and quality-management process; PV contact nominated on registration.