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Looking for 7759-35-5 / Segesterone Acetate API manufacturers, exporters & distributors?

Segesterone Acetate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Segesterone Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Segesterone Acetate manufacturer or Segesterone Acetate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Segesterone Acetate manufacturer or Segesterone Acetate supplier.

PharmaCompass also assists you with knowing the Segesterone Acetate API Price utilized in the formulation of products. Segesterone Acetate API Price is not always fixed or binding as the Segesterone Acetate Price is obtained through a variety of data sources. The Segesterone Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Segesterone Acetate

Synonyms

Nestoron, 7759-35-5, Elcometrine, St-1435, Segesterone acetate [usan], 17-hydroxy-16-methylene-19-norpregn-4-ene-3,20-dione acetate

Cas Number

7759-35-5

Unique Ingredient Identifier (UNII)

9AMX4Q13CC

About Segesterone Acetate

Segesterone acetate is a steroidal progestin or synthetic progesterone and a 19-norprogesterone derivative with no CH3 group radical in position 6. In animal studies, segesterone acetate was shown to be one of the most potent progestins. It mediates progestational activity 100 times higher than that of [progesterone]. It is commonly sold under the brand names Nestorone and Elcometrine and serves as an active component in hormonal contraceptives. It is also used as a treatment for endometriosis in South American countries. Segesterone acetate binds selectively to progesterone receptors and not androgen receptors. Due to its rapid hepatic metabolism, segesterone acetate must be administered parenterally. Segesterone acetate is not an orally active compound, but it is proved to be a potent anti-ovulatory agent when given in implants, vaginal rings or percutaneous gel. On August 10, 2018, Annovera containing segesterone acetate and [ethinyl estradiol] was granted approval by the U.S. Food and Drug Administration (FDA) as the first and only contraceptive that provides an entire year of protection against unintended pregnancy while entirely under a woman's control. According to the Center for Disease Control, more than 43 million women in the U.S. are at risk of unintended pregnancy, which may be associated with an elevated risk for improper prenatal care, premature and low-birth-weight infants, and physical and mental health risks. The introduction of this new contraceptive method offers an expansion of birth control options for women while maintaining high efficacy and acceptability similar to existing shorter-acting combined hormonal methods. In clinical trials, Annovera achieved a 97.3% success in pregnancy prevention. Annovera is administered as a vaginal ring that is in place for 21 days and removed for 7 days each cycle. As with other hormonal contraceptives, Annovera carries the risk for serious cardiovascular events.

St 1435 Manufacturers

A St 1435 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of St 1435, including repackagers and relabelers. The FDA regulates St 1435 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. St 1435 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of St 1435 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

St 1435 Suppliers

A St 1435 supplier is an individual or a company that provides St 1435 active pharmaceutical ingredient (API) or St 1435 finished formulations upon request. The St 1435 suppliers may include St 1435 API manufacturers, exporters, distributors and traders.

click here to find a list of St 1435 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

St 1435 USDMF

A St 1435 DMF (Drug Master File) is a document detailing the whole manufacturing process of St 1435 active pharmaceutical ingredient (API) in detail. Different forms of St 1435 DMFs exist exist since differing nations have different regulations, such as St 1435 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A St 1435 DMF submitted to regulatory agencies in the US is known as a USDMF. St 1435 USDMF includes data on St 1435's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The St 1435 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of St 1435 suppliers with USDMF on PharmaCompass.

St 1435 NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing St 1435 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for St 1435 API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture St 1435 as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain St 1435 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a St 1435 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of St 1435 suppliers with NDC on PharmaCompass.

St 1435 GMP

St 1435 Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of St 1435 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right St 1435 GMP manufacturer or St 1435 GMP API supplier for your needs.

St 1435 CoA

A St 1435 CoA (Certificate of Analysis) is a formal document that attests to St 1435's compliance with St 1435 specifications and serves as a tool for batch-level quality control.

St 1435 CoA mostly includes findings from lab analyses of a specific batch. For each St 1435 CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

St 1435 may be tested according to a variety of international standards, such as European Pharmacopoeia (St 1435 EP), St 1435 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (St 1435 USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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