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mitotane

Tablets 500 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #30013
The company, established in 2016 and later restructured as a private limited entity in 2018, specializes in manufacturing APIs, advanced intermediates, and finished dosage forms. With robust relationships in the pharmaceutical industry, it has built a strong customer base of over 50 clients and achieved an annual turnover exceeding 200 crore. The company operates extensive facilities capable of scaling from lab-scale development to bulk production, supporting its global expansion strategy. Committed to ethical practices and social responsibility, the company aims to make healthcare affordable and accessible worldwide, with export markets across Asia, Latin America, and Africa.

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What is Mitotane?

Mitotane is a steroidogenesis inhibitor and cytostatic antineoplastic. Mitotane drug is a cancer medicine to treat adrenal cortical carcinoma that could not be treated by surgery. It works by slowing growth or reducing the size of the tumor. Bristol and Myers Squibb produce mitotane medicine, they market it as an orphan drug due to the rare patients in need. It was developed in 1960. European Union had the marketing authorization for Mitotane in 2004.

Mitotane wholesalers and manufacturers:

Mitotane is a globally found medicine; there are 15 reliable international mitotane suppliers. Three countries manufacture mitotane drugs. The leading Mitotane manufacturer is Bristol and Myers Squibb. Mitotane is also known as Lysodren for its Bristol and Myers Squibb brand name or Opeprim. Mitotane distributors market it in the form of oral tablets of 500 mg and sometimes in powder.

Mitotane for sales:

The retail prices for Mitotane depend on the form the product is manufactured. For 500 mg oral tablets, Mitotane costs from $5 to $9 per unit in the US. For powder, Mitotane costs around $8 per gram in the US. On Pipelinepharma online B2B marketplace, Mitotane is available from manufacturers from the European Union. Pipelinepharma platform helps Mitotane distributors to globally find qualified manufacturers that have gone through quality control procedures to verify those qualifications. It allows you to save time and budget sourcing for qualified partners, Pipelinepharma has already done this part of the job. On the company website, you can find a list of many pharmaceutical products, including Mitotane. If you are interested in this product, you can easily place an order on the Pipelinepharma platform to find Mitotane manufacturers and start doing business.

How to use the Mitotane drug?

The dosage of Mitotane depends on the stage of the treatment. At the initial stage, an adult should take 2 to 6 g orally of Mitotane per day, in 3 or 4 doses. At the maintenance stage, an adult should take 9 to 10 g orally of Mitotane per day in 3 or 4 doses. Finally, as a maximum dosage, an adult should not take more than 16 g of Mitotane. Mitotane medication can have some side effects; the most common ones for oral medicine are nausea, anorexia, loss of appetite, diarrhea, drowsiness, weakness, darkening of the skin. Mitotane oral tablets must be stored at room temperature, away from heat, moisture, and direct light.

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