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Leuprorelin acetate manufacturers

10 products found

Filters

10 products found

leuprorelin acetate

Powder and solvent for solution for injection 3.75 mg, 22.5 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Unavailable markets
Australia , Canada , Egypt , Hungary , Serbia , Saudi Arabia , United States
Comments
Not available: EU, USA, Australia, Canada, MENA, GCC
Manufacturer #6301
A pharmaceutical manufacturer based in the EU that has been active in 50+ countries selling its products in Europe, MENA, LATAM, and NA for 20+ years. Main therapeutic area include oncology and urology. The company's production lines are GMP-compliant. The main dosage forms includes injectable. The company possesses subsidiaries in LATAM

Manufacturer usually replies in 4 days

leuprorelin acetate

Powder and solvent for solution for injection 45 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Not available: EU, USA, Australia, Canada, MENA, GCC
Manufacturer #6301
A pharmaceutical manufacturer based in the EU that has been active in 50+ countries selling its products in Europe, MENA, LATAM, and NA for 20+ years. Main therapeutic area include oncology and urology. The company's production lines are GMP-compliant. The main dosage forms includes injectable. The company possesses subsidiaries in LATAM

Manufacturer usually replies in 4 days

leuprorelin acetate

Injection 14 mg/2.8 ml

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
United States
GMP approvals
FDA
Manufacturer #28190
This privately held company develops, manufactures, and commercializes high-quality, affordable generic pharmaceuticals globally. Their focus is on products with formulation challenges and first-to-market opportunities within the generic space. Key therapeutic areas include those requiring complex formulations like injectables, sterile ophthalmic, and dermal products. They specialize in solid oral dosage forms through partnerships with other manufacturing facilities. The company holds GMP certifications and has a track record of developing patented product formulations. Their main production facility in North America is equipped for multi-format packaging and end-product release testing, ensuring a seamless process from bulk manufacturing to finished goods.

Manufacturer usually replies in 7 days

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Leuprorelin acetate

Leuprorelin acetate also known as leuprolide is a manmade version of a hormone. It treats hormone-responsive cancers such as prostate & breast cancers and estrogen-dependent conditions such as endometriosis, uterine fibroids, and early puberty. It can also reduce the risk of premature ovarian failure in females on cyclophosphamide-based chemotherapy. Leuprorelin acetate in combination with triptorelin and Goserelin delays puberty in transgender youth, till they reach the age for hormone replacement therapy. It is considered for treating paraphilias and tested for reducing sexual urges in pedophiles and other cases of paraphilia. Leuprorelin acetate is sold under the Brand names Eligard, Leuprofact, Lucrin Depot among others. But due to its efficacy, it has found a place on the WHO list of essential medicines. Since the expiry of the initial patent protection, it is now made and sold around the world by several manufacturers. Abbott Laboratories filed the first patent for Leuprorelin in 1973 and was introduced for medical use in 1985. Initially sold only for daily injection, by 1989, a depot injection formulation was introduced to the market.

Dosage and administration

The usual recommended dose is 1 mg or 0.2 mL or 20-unit mark injected in a single daily subcutaneous injection. Like other chronically subcutaneous injections, the sites for injecting are to be varied periodically. Every 0.2 mL contains 1 mg of leuprolide acetate, sodium chloride for tonicity adjustment, and 1.8 mg of benzyl alcohol as preservative and water for injection.

The price of Leuprorelin acetate In the USA, the consumer has to pay an average retail price of $9,652.96 for a supply of 5 kits containing a 2.8ml vial of 1mg/0.2ml. In India, a syringe with 22.5mg costs around USD 273.

How does it work?

Leuprorelin is a gonadotropin-releasing hormone analog. It acts as an agonist at pituitary GnRH receptors. This Agonism of GnRH receptors stimulating of luteinizing hormone and follicle- stimulating hormone secretion by the anterior pituitary. This eventually leads to increased serum estradiol and testosterone levels via the normal physiology of the hypothalamic–pituitary–gonadal axis. A protracted downregulation of GnRH receptor activity is the goal to ultimately decrease LH and FSH secretion. This leads to hypogonadism and thus a dramatic reduction in estradiol and testosterone levels regardless of sex.

Finding Leuprorelin Acetate Manufacturers and Suppliers:

The process of finding trusted Leuprorelin Acetate manufacturers and Leuprorelin Acetate suppliers can be made quicker and more accessible by using Pipelinepharma's online platform, a B2B marketplace that lets you finalize the deals of pharmaceutical products in a matter of a few clicks. In addition, it is an easy-to-use online platform to grow your business opportunities. The robust search engine makes it convenient to search for manufacturers and suppliers of Leuprorelin Acetate. The search can be further refined with industry-specific filters such as dossier type, country of origin, GMP approvals, and search criteria for Wholesaler, etc. helping to get in contact with the preferred manufacturer and supplier readily.

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