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Isotretinoin Brands, Price and API Manufacturers in China

Isotretinoin Brands, Price and API Manufacturers in China

by PharmaSources

June 22, 2021

Isotretinoin or 13-cis-retinoic acid is a medicine commonly used to treat acne. The drug is significantly effective against cystic acne, which has not responded to other treatment options.

It may also help to prevent certain skin cancers such as squamous cell carcinoma. It is a retinoid, which means it is related to vitamin A. Isotretinoin works by reducing facial sebum production, which is a risk factor for severe acne.

This product is the ideal cure for all types of acne.

Definition

Isotretinoin is a natural retinoic acid and may have potential antineoplastic activity. The product binds to nuclear retinoic acid receptors and activates them. This, in turn, promotes apoptosis and cell differentiation. It has a potent anti-inflammatory and immunomodulatory action, preventing keratinization.

Isotretinoin

Chemical and Physical Features 

  • CAS Number: 4759-48-2

  • Molecular Formula: C20H28O2

  • Weight: 300.4

  • Appearance: Yellow crystals or reddish-orange plates from isopropyl alcohol

  • Boiling point: 462.8

  • Melting point: 372 to 374 °F

  • Solubility: 1 mg/mL at 72° F

  • LogP: 5.66

  • Drug class: Dermatologic Agents

Structure

Brand Names

Accutane, Claravis, Absorica, Amnesteem, Myorisan, and Zenatane

Isotretinoin Forms And Specifications

The product is available in the mentioned forms and specifications:

  • Isotretinoin API Powder: It is the active ingredient in the medicine, which is used to manufacture medicines

  • Isotretinoin Accutane: It is a brand name for Isotretinoin and is available as a capsule to be taken orally

  • Isotretinoin Capsules: It is also available as a tablet to be taken orally, usually twice a day

  • Isotretinoin Cream: Isotretinoin is available as a topical cream or gel to be applied to the affected areas with acne. However, this is not the usual form of using it.

Isotretinoin Vs. Tretinoin

Isotretinoin and tretinoin are isomers used to manage acne and belong to the group of medicines known as retinoids. These drugs are prepared from vitamin A. 

However, their use is different when it comes to acne.

Tretinoin is used as a topical application to manage mild to moderate acne. It can also be used for sun damage, age spots, and wrinkles. The product works by increasing the speed at which the cells turn over. All this helps for clearing blackheads, unclog pores, and inflamed pimples.

On the other hand, Isotretinoin is for oral use and is commonly recommended for severe acne. It is not beneficial for hyperpigmentation or signs of aging. The product may also be used for milder acne that did not respond to other treatment or cases of acne with scars.

Isotretinoin Vs. Accutane

They are the same product. Isotretinoin is the generic name, and Accutane is the brand name.

Mechanism Of Action of Isotretinoin

Isotretinoin works by altering cell differentiation, cell cycle, apoptosis, and survival. All this decreases sebum production. It also hinders the growth of acne-causing bacteria and blockage of pores. Isotretinoin triggers apoptosis in sebocytes, reducing sebum production. 

The product reduces hyperkeratinization, which reduces the formation of blackheads or comedones. While it cannot kill the bacteria directly, it reduces the pore size, making the environment unfavorable for bacterial growth. Lastly, it can boost your immune mechanism and reduce inflammation.  

All in all, Isotretinoin hinders the functioning of sebaceous glands and keratinization. 

Isotretinoin Manufacturing Process

This product can be formed in various ways. Here is one way of producing it:

  • A dienolate of sodium 3,3-dimethyl acrylate is reacted with β-ionylideneacetaldeyhyde

  • This process is carried out for 12 hours at -78ºC

  • This results in hydroxy acid intermediate

  • The intermediate converts to intermediate lactone 

  • Treating intermediate lactone with base gives Isotretinoin

Isotretinoin Uses

  • Isotretinoin For Acne: It is used for managing nodular or cystic acne that does not respond to antibiotics or other treatment options. It may also be helpful for mild or moderate acne that stubborn to conventional treatment. 

  • Other Uses: It may also be effective in preventing some skin cancers such as squamous cell carcinoma. The product may also be effective for keratinizing disorders.

Isotretinoin Dosage

The usual dose may be 0.5 – 1.0 mg/kg a day in divided doses. The medicine should be taken with a meal, usually for 15 to 20 weeks.

However, the dose depends on your weight, medical condition, and response to the treatment.

Isotretinoin Side Effects

The use of the medicine is usually safe in most people. However, as with other medication, it may cause some side effects in some people.

Common side effects include:

  • Dry lips or cheilitis

  • Dry mouth, dry skin, or dry nose

  • Increased sensitivity to the sun

  • Vision problems

  • Headache

  • Cold symptoms including sneezing, stuffed nose, and sore throat

  • Skin reactions

  • Changes in skin color

  • Tiredness

  • Flushing and/or sweating

Isotretinoin API Price

The average isotretinoin API price may range between $1.2-1.8 per gram.

Isotretinoin API Manufacturers in China

Many reputed pharmaceutical API manufacturers offer Isotretinoin in China. Some of them include:

  • Chongqing Huapont Pharmaceutical Co., Ltd.: It is among the well-known dermatological drug producer in China. Their production highly relies on science and technology and has 25 years of experience. They provide products related to skin disorders, cancers, tumors, tuberculosis, respiratory problems, and cardiovascular conditions. You can get both APIs and FDFs for the international and domestic markets.

  • Taizhou Tyloo Biopharm Co., Ltd: This biopharma company deals in the manufacturing and sales of pharmaceutical intermediates, APIs, and nutrition ingredients. They aim to offer high-quality products at a competitive price. 

Bulk Production

You can also buy Isotretinoin in bulk from PharmaSources.com. It is a vertical e-commerce online destination with many high-quality global suppliers. PharmSources offers high-quality products to about 211 countries and regions. You can also compare products sold by various distributors and companies and thus make an informed decision.

FAQ

How Long Does Isotretinoin Take to Work?

This product is usually used for a specific period, unlike other medicines that can be used on and off for a more extended time. 

In most cases, you will be able to see Isotretinoin's effect by seven to ten days. The medicine is effective in four out of five people. They have almost clear skin in about four months.

What's The Market Size Of Isotretinoin?

The global market size of Isotretinoin products was $1157.7 million in 2019, which is expected to grow up to $ 1314.9 million by 2026. The expected growth is a CAGR of 1.8 between 2021-2026.

How Much Does Isotretinoin Cost?

The average cost of oral Isotretinoin pills around 10 mg is $360. 

References:

  1. https://go.drugbank.com/drugs/DB00982 

  2. https://en.wikipedia.org/wiki/Isotretinoin

  3. https://www.webmd.com/drugs/2/drug-6662/isotretinoin-oral/details

  4. https://www.ncbi.nlm.nih.gov/books/NBK525949/

  5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2835909/

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