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Apalutamide (Amorphous & Form B)

Apalutamide (Amorphous & Form B) API

Apalutamide (Amorphous & Form B)-API

CAS Number: 956104-40-8

Therapeutic Category
Anti-Cancer/ Oncology
API Technology
Synthetic
Dose Form
Oral Solids
Dr Reddy's Development Status
Available
Available Regulatory Filing
Brazil DMF
USDMF
Innovator Brand (USA)
Erleada
Plant
1015(SEZ)
No Document Available
Off
Region/Country
China

Mechanism of Action

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.

Indication

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

Dr. Reddy's Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Apalutamide (Amorphous & Form B) API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Apalutamide (Amorphous & Form B) API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

Oncology API Products:

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Disclaimer

No information in this catalog - 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, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.

FAQs

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.

Amorphous form is stable for 3 months at room temperature and recommended storage conditions of 2-8°C. Extended stability will be established.

We offer Crystalline Form-B

Available in Tablet dosage form with strength of 60 Mg

Dr.Reddys is the early mover in Apalutamide API manufacturing and files the USDMF

Apalutamide belongs to class 2 of BCS classification.

Apalutamide is an androgen receptor inhibitor used to treat non metastatic, castration resistant prostate cancer.