Sunitinib Malate 12.5mg Capsules

Sunitinib Malate 12.5mg Capsules: What the Published Guidance Says

Cytotoxic and targeted agents spanning the taxane, antifolate and EGFR-tyrosine-kinase-inhibitor classes, supplied with the analytical and stability documentation oncology procurement requires.

Sunitinib Malate 12.5mg Capsules is specified against its own monograph, pack size and market registration, so the guidance below is worth reading together with the Oncology range overview.

• EGFR tyrosine-kinase inhibitors and their toxicity profile In its review of non-small cell lung cancer, the WHO Expert Committee recorded that EGFR tyrosine-kinase inhibitors are generally well tolerated, with diarrhoea occurring in more than 60% of patients treated, characteristic dermatological toxicity and rash across the class, and potential hepatic toxicity. Rare but severe gastrointestinal toxicity, including perforation, was noted particularly with erlotinib. WHO EML Expert Committee — Non-small cell lung cancer review
• 2025 extended access to checkpoint inhibitors Pembrolizumab was added to the Model List as first-line monotherapy for metastatic cervical cancer, metastatic colorectal cancer and metastatic non-small cell lung cancer, with atezolizumab and cemiplimab as therapeutic alternatives for the lung indication. WHO — Essential medicines list updated to include key cancer and diabetes treatments (5 Sep 2025)
• WHO applies a hard benefit threshold to cancer listings When the September 2025 revision was prepared, WHO evaluated 25 cancer medicines across seven applications and states that only therapies proven to prolong life by at least four to six months are included on the Model List. Listing is therefore a deliberately narrow signal, not a catalogue of everything approved. WHO — Essential medicines list updated to include key cancer and diabetes treatments (5 Sep 2025)

These points are quoted because they shape how Sunitinib Malate 12.5mg Capsules is specified, labelled and purchased — including strength selection, pack size and the artwork wording. Confirm each one against the approved product information in your market before finalising a purchase order.

Sunitinib Malate 12.5mg Capsules — Supply Parameters

The same therapeutic range is supplied in several presentations, so one purchase order can cover a mixed requirement: Afatinib Dimaleate 40mg Tablets, Erlotinib Hydrochloride 150mg Tablets, Gefitinib Tablets 250mg, Pemetrexed Disodium Injection 100mg, Paclitaxel Albumin-Bound 100mg/20mL.

Quality Control, Pharmacopoeial Standards & Documentation

Products are manufactured and tested against USP, EP, BP and CP monographs, with incoming raw-material inspection, in-process monitoring and full finished-product testing.

Sunitinib Malate 12.5mg Capsules is released against the pharmacopoeial monograph named on your order (USP, EP, BP or CP). Where no monograph exists for the exact presentation, the specification is agreed with you in writing before manufacture and is attached to the certificate of analysis.

Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.

A typical release panel for this presentation covers:

• Testing for description and identification
• Testing for assay of the active substance
• Testing for related substances and impurities
• Testing for dissolution or release profile (solid oral forms)
• Testing for uniformity of dosage units
• Testing for water content and pH where applicable

COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.

Packaging, Labelling & Export

• Pack size: Blister pack (PVC-Alu) or HDPE bottle, typically 7, 14, 28, or 30 capsules per blister pack or bottle. Non-standard pack sizes can be quoted against your artwork.
• Storage: Store below 25°C, in a dry place, protected from light and moisture. Keep container tightly closed. Do not freeze..
• Shelf life: 36 months (unopened). Stability data for the marketed pack is included in the dossier.
• Labelling: artwork can be produced in English, Arabic, French, Russian and Spanish, with your own brand and language mix, subject to the labelling rules of the destination market.
• Export: GMP certificate, COA, certificate of origin, packing list and, where required, the free-sale or marketing authorisation certificate from the country of manufacture.

Registration, Dossier & Tender Support

Sinophare Bio-technology Co., Ltd. holds DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. That registration identifies the legal manufacturer on the certificate of analysis, the GMP certificate and the documents filed with your national medicines authority.

• CTD dossier modules 1–5 in editable and PDF form, with the finished-product and API sections cross-referenced.
• Site Master File and GMP certificate for the manufacturing workshops.
• Method validation, stability protocol and the shelf-life justification for the marketed pack.
• Answers to authority questions during assessment, handled by the regulatory contact who prepared the file.
• Tender and framework documentation, including pre-qualification questionnaires and sample logistics.

This page describes Sunitinib Malate 12.5mg Capsules as a product of the cancer medicines reviewed for the WHO Model List family. A WHO or national listing is a supply-context fact, not an approval in your market; marketing authorisation remains specific to each country.

Related Oncology Products

• Afatinib Dimaleate 40mg Tablets — 40mg
• Erlotinib Hydrochloride 150mg Tablets — 150mg
• Gefitinib Tablets 250mg — 250mg
• Pemetrexed Disodium Injection 100mg — 100mg
• Paclitaxel Albumin-Bound 100mg/20mL — 100mg

Browse the full Oncology range; all Capsules; the complete product catalogue.