About Olaparib (Form A) API

Mecanismo de Ação

Poly(ADP-ribose) polymerases (PARPs) are multifunctional enzymes comprising 17 members. They are involved in essential cellular functions, such as DNA transcription and DNA repair.8 PARPs recognize and repair cellular DNA damage, such as single-strand breaks (SSBs) and double-strand breaks (DSBs). Different DNA repair pathways exist to repair these DNA damages, including the base excision repair (BER) pathway for SSBs and BRCA-dependent homologous recombination for DSBs.2

Olaparib is a PARP inhibitor: while it acts on PARP1, PARP2, and PARP3, olaparib is a more selective competitive inhibitor of NAD+ at the catalytic site of PARP1 and PARP2. Inhibition of the BER pathway by olaparib leads to the accumulation of unrepaired SSBs, which leads to the formation of DSBs, which is the most toxic form of DNA damage. While BRCA-dependent homologous recombination can repair DSBs in normal cells, this repair pathway is defective in cells with BRCA1/2 mutations, such as certain tumour cells.4 Inhibition of PARP in cancer cells with BRCA mutations leads to genomic instability and apoptotic cell death. This end result is also referred to as synthetic lethality, a phenomenon where the combination of two defects - inhibition of PARP activity and loss of DSB repair by HR - that are otherwise benign when alone, lead to detrimental results

Indicação

Olaparib is indicated for the maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.8,11

Olaparib is indicated in combination with bevacizumab for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.8,11

Olaparib is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy

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 Olaparib (Form A) 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.