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dutasteride Cutaneous solution 0.01 %, 0.02 %, 0.05 %

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Unavailable markets
Costa Rica
Manufacturer #1338

The company is a prominent player in the generic pharmaceutical industry with strong capabilities in research, development, manufacturing, and commercialization. It has received multiple GMP certifications from international regulatory bodies, such as those from Bavaria, Switzerland, Slovenia, and Mexico, underscoring its commitment to quality and global standards. Recognized for its innovation, the company has earned numerous product patents and prestigious awards, such as the Pharmexcil Patent Award. With ISO certifications for quality and environmental management, a robust infrastructure of five manufacturing facilities in India, and strategic partnerships for producing HIV/AIDS drugs, the company demonstrates a strong focus on expanding its global footprint and delivering affordable healthcare solutions.

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Dutasteride

Dutasteride is a medication primarily used to treat the symptoms of an enlarged prostate but it is a long-term medication the benefits of which start showing after using it for a few months. It is also prescribed for scalp hair loss in men and as a part of hormone therapy in transgender women. Dutasteride inhibits 5α-reductase, thus classified as an antiandrogen. It decreases the production of an androgen sex hormone called Dihydrotestosterone. Dutasteride is sold under the brand names Avodart, Combodart, Duodart among others. GlaxoSmithKline first patented Dutasteride in 1993 and approved for medical use in 2001. It is currently sold as a generic medication prescribed to more than one million American citizens. Since its launch, Its sales has spread to many other countries, including throughout Europe and South America. The patent protection expired in 2015 and the drug has since then has been made sold as a generic medication at very low prices in the US and around the world. In South Korea, it is used in the treatment of scalp hair loss since 2009 and in Japan since 2015. However, it has not been approved for the same user in the USA. Dosage Forms and Strengths Dutasteride is sold as Capsules of 0.5 mg strength. In the treatment of Benign Prostatic Hyperplasia, the dose is 0.5 mg, taken orally once a day.

The price of Dutasteride

In the USA, the consumer has to pay USD 21 for a supply of 30 oral capsules of 0.5 mg. Dutasteride is sold at relatively lower prices in other parts of the world. For example, In India, the supply of 30 tablets of 0.5mg will cost the consumer USD 1.8.

How does Dutasteride work?

Dutasteride is a synthetic 4-azasteroid compound. It is different in that it selectively inhibits both type 1 and type 2 isoforms of steroid 5 alpha-reductase. This reductase is used to treat benign prostatic hyperplasia in men with an enlarged prostate. Dutasteride increases the flow of urine and can also reduce the need for prostate surgery. Dutasteride is prescribed with Tamsulosin. Dutasteride action stops or prevents the conversion of testosterone to Dihydrotestosterone.

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