Norethisterone

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CAS

68-22-4

Treatment Category

Hormone

Molecular Formula

C20H26O2

Molecular Weight

298.4 g/mol

Nature

Amorphous

Status

Commercial

EU DMF Readiness

Ready

US DMF Readiness

Ready

Ornet Norethisterone Characteristics

  • Pure, stable, amorphous nature
  • Excellent control of impurity profile
  • Particle Size Distribution as per the needs of the Finished Drug Formulator

Drug Description:

Norethisterone is a synthetic second-generation progestin used for contraception, prevention of endometrial hyperplasia in hormone replacement therapy, and in the treatment of other hormone-mediated illnesses such as endometriosis. Norethisterone has features of mimicking the effects of the natural female hormone progesterone, which is a female hormone in the ovaries responsible for the menstrual cycles and maintaining the pregnancy in a woman. Abnormal progesterone levels can ruin the menstrual cycle. Hence, Norethisterone can help in treatment of heavy and painful periods, premenstrual tension (PMT), irregular periods, and Endometriosis. This drug can be used as monotherapy or in combination with other medicines. Norethisterone is administered through oral route by way of uncoated and film-coated tablets.

Mechanism of Action:

Progestins like Norethisterone exert their effects on target cells via binding to progesterone receptors that result in downstream changes to target genes. Target cells are found in the reproductive tract, breast, pituitary, hypothalamus, skeletal tissue, and central nervous system. Contraceptive efficacy is derived mainly from changes to the cervical mucus, wherein Norethisterone increases the cell content and viscosity of the mucous to impede sperm transport and migration. Norethisterone also induces a variety of changes to the endometrium that make it inhospitable for implantation. Working via a negative feedback loop, Norethisterone also acts on both the hypothalamus and anterior pituitary to suppress the release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from the anterior pituitary. Suppression of these hormones prevents follicular development, ovulation, and corpus luteum development.

API Expertise:

Ornet Pharmaceuticals, based out of Gujarat, India, is a leading manufacturer and global supplier of Norethisterone API. Driven by technically sound, research-oriented leaders, each with over 2 decades of hands-on experience, Ornet develops and manufactures a wide array of complex APIs catering to multiple categories in its product portfolio, such as anti-diabetics, blood related, hormones, etc. Ornet’s Norethisterone API is the result of the “Quality over Quantity” approach taken by the organization for all R&D and manufacturing practices. This approach, along with the strategically located manufacturing facility in Gujarat, allows for Ornet to be a primary source, both domestically and globally, for all API needs.

DISCLAIMER:

Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).