About Pemetrexed Disodium Heptahydrate API
Therapeutic Category Anti-Câncer / Oncologia

CAS Number
150399-23-8
API Technology
High Potent
Dose Form
Powder
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF
Mecanismo de Ação
ALIMTA is a folate analog metabolic inhibitor that disrupts folate-dependent metabolic processes essential for cell replication. In vitro studies show that pemetrexed inhibits thymidylate synthase (TS), dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase (GARFT), which are folate-dependent enzymes involved in the de novo biosynthesis of thymidine and purine nucleotides. Pemetrexed is taken into cells by membrane carriers such as the reduced folate carrier and membrane folate binding protein transport systems. Once in the cell, pemetrexed is converted to polyglutamate forms by the enzyme folylpolyglutamate synthetase. The polyglutamate forms are retained in cells and are inhibitors of TS and GARFT.
Indicação
ALIMTA® is a folate analog metabolic inhibitor indicated:
- In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).
- In combination with carboplatin and pembrolizumab for the initial treatment of patients with metastatic, non-squamous NSCLC. This indication is approved under accelerated approval based on tumor response rate and progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
- As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
- As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1) Limitations of Use: ALIMTA is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.
- Initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
Especialização do Dr. Reddy
Com sede em Hyderabad, Índia, o Dr. Reddy's Laboratories é um dos principais fornecedores de Ingredientes Farmacêuticos Ativos (API) do mundo. O negócio de API do Dr. Reddy é um parceiro preferencial para empresas farmacêuticas nos EUA, Europa, Brasil, América Latina, Japão, China, Coréia e mercados emergentes.
Os negócios de API do Dr. Reddy prosperam com os profundos pontos fortes técnicos estabelecidos nos últimos 30 anos no desenvolvimento e fabricação de APIs complexas, como esteróides, peptídeos, moléculas complexas de cadeia longa e APIs altamente potentes (HPAPIs / medicamentos para oncologia). Essa experiência é complementada por nossa capacidade em propriedade intelectual e assuntos regulatórios, o que nos ajuda a cumprir e exceder consistentemente os padrões regulatórios. A API do Dr. Reddy Dissódio Pemetrexede (hepta-hidratado) é o resultado de uma extensa experiência em pesquisa e desenvolvimento, PI e regulamentação.
Um componente essencial para ajudar nossos clientes a serem os primeiros no mercado é uma cadeia de suprimentos responsiva. Conseguimos isso garantindo que todas as nossas instalações estejam operando com eficiência e com os mais recentes padrões de qualidade, segurança e produtividade. Uma forte interconexão entre negócios e fábricas permite uma reação rápida às mudanças dinâmicas do mercado, para que possamos evitar escassez e atender a súbitas oscilações na demanda.
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