Dutasteride API
CAS Number: 164656-23-9
About Dutasteride API
Therapeutic Category
Urology
API Technology
Synthetic
Dose Form
Oral Solids
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF
Mechanism of Action
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT). DHT is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. Testosterone is converted to DHT by the enzyme 5 alpha-reductase, which exists as 2 isoforms, type 1 and type 2. The type 2 isoenzyme is primarily active in the reproductive tissues, while the type 1 isoenzyme is also responsible for testosterone conversion in the skin and liver.
Dutasteride is a competitive and specific inhibitor of both type 1 and type 2 5 alpha-reductase isoenzymes, with which it forms a stable enzyme complex. Dissociation from this complex has been evaluated under in vitro and in vivo conditions and is extremely slow. Dutasteride does not bind to the human androgen receptor.
Indication
AVODART is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
- Improve symptoms,
- Reduce the risk of acute urinary retention, and
- Reduce the risk of the need for BPH-related surgery.
AVODART in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
Limitations of Use: AVODART is not approved for the prevention of 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 Dutasteride 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 Dutasteride 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.
Related Resources
Tech Sheet on Dutasteride
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT). DHT is the androgen primarily responsible for the prostate gland's initial development and subsequent enlargement. Testosterone is converted to DHT by the enzyme 5-alpha-reductase, which exists as 2- isoforms, type 1 and type 2. The type 2 isoenzyme is primarily active in the reproductive tissues, while the type 1 isoenzyme is also responsible for testosterone conversion in the skin and liver [1].
Dutasteride is indicated for treating symptomatic benign prostatic hyperplasia (BPH). When combined with the alpha-adrenergic antagonist, tamsulosin is indicated for treating symptomatic BPH in men with an enlarged prostate [1]. Furthermore, Dutasteride is also approved for treating male androgenic alopecia in South Korea and Japan at a dose of 0.5mg/ day [2].
Dr. Reddy's API Offering
- We offer polymorphic crystalline form 2.
- A novel synthetic process developed for crystalline form 2.
- Quality by design (QBD) based API development for a consistent quality profile.
We manufacture Dutasteride API at our cGMP manufacturing facility, which was successfully inspected by international regulatory authorities - USFDA, WHO GMP, KFDA, PMDA, Health Canada, and ANVISA. We have reliable KSM suppliers to ensure timely deliveries and adhere to stringent specifications.
To know more about our API offerings, please read the Tech sheet on Dutasteride API by filling the contact form below.
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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
Store at room temperature between 20°C and 25°C.
Dutasteride is used alone or in combination with tamsulosin (Flomax®) to treat men who have symptoms of an enlarged prostate gland, which is also known as benign prostatic hyperplasia (BPH). Benign enlargement of the prostate is a problem that can occur in men as they get older.
Women and children should not use this medicine. Pregnant women or women who may become pregnant should not handle or touch the capsules. Dutasteride can be absorbed through the skin and can cause birth defects in male fetuses.
Dutasteride belongs to class 4 of BCS classification
Dutasteride is available in capsule dosage form with 0.5 Mg strength
We offer polymorphic form 2
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