isotretinoin Capsules 5 mg, 10 mg, 20 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP, FDA
Manufacturer #17457
In the past fifty years, the company has reached significant milestones—a result of enviable performance, strict adherence to the highest ethical and operational standards, and full compliance with global regulatory authorities. During this journey, they have emerged as one of the leading in-house development partners based in Europe, specializing in the development, registration, manufacturing, and life-cycle management of highly complex pharmaceutical technologies and generic formulations.

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Isotretinoin is the given name for a drug that is meant for Acne treatment. More specifically, for Acne that is severe and does not respond to various other kinds of milder treatments.

Uses of Isotretinoin

As a derivative of vitamin A, Isotretinoin can also be prescribed to and used by patients who are suffering from various skin-related problems, Acute Nonlymphocytic Leukemia, Granuloma, and many others.

How it works

Most of the Isotretinoin suppliers only have it in oral capsule shape. Once it is ingested and dissolved, the drug stops the accumulation and production of Sebum, which is the skin’s natural oil. Acne is a direct result of excess Sebum production which clogs up pores, Bacteria feed on the Sebum and aggravate skin, causing inflammation we all know as Acne. To be precise, Isotretinoin manufacturers design the drug to diminish and suppress sebum production. The skin, however, dries out, but after treatment is completed, Isotretinoin should successfully help the user get rid of Acne.

Daily dosage & other important information

Daily dosage varies according to the patient and any individual case. For patients who are prescribed to take Isotretinoin, it is more than essential never to exceed the recommended dosage as it could lead to some unwanted side effects. Finally, the course of treatment is anywhere between 4 months and a half a year. Since it is a strong drug, there are strong effects on the skin and the body. However, they vanish in a couple of weeks after the patient ends his/her course of Isotretinoin. It is only administered to people over the age of 12. Many people do not know, but skin condition might very well worsen after a patient begins his/her treatment with Isotretinoin. Improvement is usually visible after a week or 10-12 days of treatment. Recurring treatments are not common.

Isotretinoin manufacturers

Isotretinoin was first developed and sold under the brand name Accutane, which is no longer available. Usually, this is not a generic drug and is instead produced and sold as a branded medicament by lots of Isotretinoin manufacturers. The more common names include Sotret, Claravis, Absorica, and many others. That being said, you might find generic versions of this medicament. Isotretinoin manufacturers and suppliers are scattered all over the globe. Besides, there are many distributors and resellers on all continents that you can rely on. And lucky for you, the Pipelinepharma marketplace can help you find Isotretinoin manufacturers, distributors, and wholesalers in one place!

Cost of Isotretinoin

Costs vary depending on manufacturers, dosage, and a couple of other factors. However, wholesale of branded Isotretinoin capsule prices usually start around 4.5-5 USD per unit and can move upwards to as high as 10-12 USD per unit. Retail prices can be significantly higher, even by as much as 200-300%. Prices of generic Isotretinoin might differ.

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Side effects

Isotretinoin is dangerous to unborn babies and thus cannot be administered to pregnant women or those who are breastfeeding. Women who are still in their childbearing years should use additional contraceptive medicaments and have a substitute, plan B, so to speak, ready. As we mentioned, this drug is a derivative of retinoid or Vitamin A; hence it should not be used at the same time as vitamin A dietary supplements. Isotretinoin and Isotretinoin manufacturers warn about the possible effects on the CNS (headaches, sleepiness), the possibility of problems to the digestive tract, muscles, and the skeletal system as well as to skin and hair.