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Hubei Gedian Humanwell Pharmaceutical Testosterone Hubei Gedian Humanwell Pharmaceutical Testosterone

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  • FILM, EXTENDED RELEASE;TRANSDERMAL - 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • GEL, METERED;NASAL - 5.5MG/0.122GM ACTUATION
  • GEL, METERED;TRANSDERMAL - 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • GEL;TRANSDERMAL - 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • GEL;TRANSDERMAL - 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • GEL;TRANSDERMAL - 50MG/5GM PACKET
  • TABLET, EXTENDED RELEASE;BUCCAL - 30MG
  • GEL, METERED;TRANSDERMAL - 1.62% (20.25MG/1.25GM ACTUATION)
  • GEL;TRANSDERMAL - 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION, METERED;TRANSDERMAL - 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 58-22-0 / Testosterone API manufacturers, exporters & distributors?

Testosterone manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Testosterone 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 Testosterone manufacturer or Testosterone supplier for your needs.

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

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

API | Excipient name

Testosterone

Synonyms

58-22-0, Androderm, Testim, Testosteron, Virosterone, Mertestate

Cas Number

58-22-0

Unique Ingredient Identifier (UNII)

3XMK78S47O

About Testosterone

A potent androgenic steroid and major product secreted by the LEYDIG CELLS of the TESTIS. Its production is stimulated by LUTEINIZING HORMONE from the PITUITARY GLAND. In turn, testosterone exerts feedback control of the pituitary LH and FSH secretion. Depending on the tissues, testosterone can be further converted to DIHYDROTESTOSTERONE or ESTRADIOL.

Testosterone Manufacturers

A Testosterone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Testosterone, including repackagers and relabelers. The FDA regulates Testosterone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Testosterone 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 Testosterone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Testosterone Suppliers

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

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

Testosterone USDMF

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

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

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

Testosterone CEP

A Testosterone CEP of the European Pharmacopoeia monograph is often referred to as a Testosterone Certificate of Suitability (COS). The purpose of a Testosterone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Testosterone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Testosterone to their clients by showing that a Testosterone CEP has been issued for it. The manufacturer submits a Testosterone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Testosterone CEP holder for the record. Additionally, the data presented in the Testosterone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Testosterone DMF.

A Testosterone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Testosterone CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Testosterone suppliers with CEP (COS) on PharmaCompass.

Testosterone WC

A Testosterone written confirmation (Testosterone WC) is an official document issued by a regulatory agency to a Testosterone manufacturer, verifying that the manufacturing facility of a Testosterone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Testosterone APIs or Testosterone finished pharmaceutical products to another nation, regulatory agencies frequently require a Testosterone WC (written confirmation) as part of the regulatory process.

click here to find a list of Testosterone suppliers with Written Confirmation (WC) on PharmaCompass.

Testosterone 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 Testosterone as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Testosterone 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 Testosterone 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 Testosterone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Testosterone NDC to their finished compounded human drug products, they may choose to do so.

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

Testosterone GMP

Testosterone 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 Testosterone 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 Testosterone GMP manufacturer or Testosterone GMP API supplier for your needs.

Testosterone CoA

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

Testosterone CoA mostly includes findings from lab analyses of a specific batch. For each Testosterone 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.

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