Active Pharmaceutical Ingredients - Dr Reddy's
Active Pharmaceutical Ingredients - Dr Reddy's

About Apalutamide (Amorphous & Form B) API

Product
  • Therapeutic Category Oncology

  • CAS Number

    956104-40-8

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Available

  • Available Regulatory Filing

    Brazil DMF, USDMF

Mecanismo de Ação

Apalutamide is an Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. Apalutamide inhibits AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription. A major metabolite, N-desmethyl apalutamide, is a less potent inhibitor of AR, and exhibited one-third the activity of apalutamide in an in vitro transcriptional reporter assay. Apalutamide administration caused decreased tumor cell proliferation and increased apoptosis leading to decreased tumor volume in mouse xenograft models of prostate cancer.

Indicação

ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

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 Apalutamida 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.

Request for Quotation

Get in touch with us by filling out the form below. Our team will reach out to you shortly!

Phone
Country *
Apalutamide (Amorphous & Form B)
Select Regulatory Requirements
Select Purpose

Related APIs

Ácido Zoledrônico

Oncology

arrow

Dasatinibe

Oncology

arrow

Adagrasib

Oncology

arrow

Cloridrato De Bendamustina

Oncology

arrow

Fruquintinib

Oncology

arrow

Venetoclax

Oncology

arrow

Tucatinib

Oncology

arrow

Ripretinib

Oncology

arrow

Abiraterona Acetato

Oncology

arrow

Azacitidina

Oncology

arrow

Bortezomibe

Oncology

arrow

Cabazitaxel

Oncology

arrow

Cabozantinib HCl

Oncology

arrow

Cabozantinib S-Malate

Oncology

arrow

Capecitabina

Oncology

arrow

Carfilzomib

Oncology

arrow

Decitabina

Oncology

arrow

Deucravacitinib

Oncology

arrow

Apalutamide (Amorphous & Form B)

Oncology

arrow

Mesilato De Eribulina

Oncology

arrow

Gemcitabine Hydrochloride

Oncology

arrow

Lomustina

Oncology

arrow

Cloridrato De Nilotinibe

Oncology

arrow

Olaparib (Form A)

Oncology

arrow

Palbociclibe

Oncology

arrow

Pazopanib

Oncology

arrow

Dissódio Pemetrexede (hepta-hidratado)

Oncology

arrow

Pirtobrutinib

Oncology

arrow

Relugolix

Oncology

arrow

Pomalidomida

Oncology

arrow

Acalabrutinib

Oncology

arrow

Capivasertib

Oncology

arrow

Lenalidomida

Oncology

arrow

Midostaurin

Oncology

arrow

Lenvatinib Mesylate (Form C & MIBK Solvate)

Oncology

arrow

Enzalutamida

Oncology

arrow

FAQs

What are the steps in monitoring and testing while taking Apalutamide?
  • This medicine may cause dizziness, tiredness, seizures, and an increase risk for falls and fractures. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If you plan to have children, talk with your doctor before using this medicine.

How do you store Apalutamide API ?
  • Amorphous form is stable for 3 months at room temperature and recommended storage conditions of 2-8°C. Extended stability will be established.

What is the polymorph form available for Apalutamide API?
  • We offer Crystalline Form-B

What is the dosage form available for Apalutamide ?
  • Available in Tablet dosage form with strength of 60 Mg

What are the DMFs available for Apalutamide API ?
  • Dr.Reddys is the early mover in Apalutamide API manufacturing and files the USDMF

What is the BCS classification for Apalutamide API?
  • Apalutamide belongs to class 2 of BCS classification.


     

What is primary purpose of using the Apalutamide API?
  • Apalutamide is an androgen receptor inhibitor used to treat non metastatic, castration resistant prostate cancer.


     

Aviso legal

No information on this website, including any reference to any product or service constitutes an offer for sale or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, in certain cases, at Dr. Reddy's sole discretion, and subject to local legal requirement, the research quantities of such products may be offered for the purpose of regulatory submissions under Section 107A of the Indian Patent Act (Bolar exemption), wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the product or service including, patent scenario in their respective markets and will be responsible for all patent related liabilities Dr. Reddy's disclaims all warranties, express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose and non-infringement.

Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.