Testosterone Cypionate

Testosterone Cypionate is a synthetic derivative of testosterone, commonly used in pharmaceutical applications due to its anabolic effects. It is a white crystalline powder that is highly lipophilic and has a molecular formula of C21H29NO3. Testosterone Cypionate is classified as a Schedule III controlled substance under the Controlled Substances Act (CSA) in the United States.

CHEMISTRY

Testosterone Cypionate is a prodrug that undergoes enzymatic conversion to its active form, dihydrotestosterone (DHT), which is responsible for its anabolic properties. The cypionate ester confers upon the molecule a longer duration of action compared to other testosterone esters.

ACTIVE PHARMA INGREDIENTS

Testosterone Cypionate serves as a key active pharmaceutical ingredient (API) in various drug formulations, particularly in treatments related to hormone replacement therapy (HRT), muscle wasting, and conditions associated with low testosterone levels. It is widely used in both oral and parenteral forms.

ACCESS ALL DATA

To browse all available information on Testosterone Cypionate, including its chemical properties, regulatory approvals, and listed suppliers, you can access comprehensive databases such as USDMF, EU Wc, and NDC API. These platforms provide detailed insights into the manufacturing and supply chain details of the compound.

API Suppliers

Testosterone Cypionate is manufactured and supplied by various reputable pharmaceutical companies and APIs suppliers. Major manufacturers include Nanjing Well Pharmaceutical, Actylis, Finar, TopChem Pharmaceuticals, and Zhejiang Xianju Pharmaceutical Co., among others. These suppliers adhere to stringent regulatory standards, ensuring the quality and safety of the API.

USDMF

The United States Drug Master File (USDMF) is a critical resource for accessing information on Testosterone Cypionate's regulatory status and approved drug products. This dataset includes details on the drug's composition, manufacturing process, and quality control measures.

EU WC

The European Union Wellness Card (EU WC) also provides relevant information on Testosterone Cypionate, including its use in European markets and compliance with EU regulatory requirements.

NDC API

In the United States, NDC (National Drug Code) is used to uniquely identify pharmaceutical products. The NDC API allows for integration of Testosterone Cypionate-related data into various systems, enabling seamless access to product information.

Listed Suppliers

For a comprehensive list of suppliers and manufacturers of Testosterone Cypionate, you can refer to databases like Aspen API, Symbiotec Pharmalab, Sanofi, LGM Pharma, Pfizer CentreOne, and others. These companies provide high-quality APIs that meet international standards.

$ API Reference Price

To obtain pricing and procurement information for Testosterone Cypionate APIs, you can consult platforms like Ref. Standards & Impurities, which provide detailed market data and reference prices.

FINISHED DOSAGE FORMULATIONS

Finished dosage formulations of Testosterone Cypionate are available in various forms, including injectable and injection solutions. Common dosages include 100mg/mL and 200mg/mL, tailored for specific therapeutic applications.

FDF Dossiers

For detailed information on finished dosage forms (FDF) of Testosterone Cypionate, you can access dossiers filed with regulatory agencies such as the FDA Orange Book. These dossiers provide comprehensive data on drug composition and therapeutic indications.

FDA Orange Book

The FDA Orange Book is a valuable resource for understanding approved drug products, including Testosterone Cypionate-based formulations. It provides insights into the regulatory process and approval status of pharmaceutical products.

Canada

In Canada, regulatory information on Testosterone Cypionate can be accessed through the Canadian Drug and Substance Control Program (CDS). This includes details on manufacturing, labeling, and distribution.

South Africa

The South African Medicines Control Council (MCC) regulates pharmaceutical products in South Africa. Information on Testosterone Cypionate can be obtained from the MCC's website or regulatory databases.

Listed Dossiers

For a list of listed dossiers related to Testosterone Cypionate, you can refer to platforms like Trifarma, Steroid SpA, and Fujifilm Diosynth Biotechnologies. These entities provide detailed regulatory information on drug products.

DRUG PRODUCT COMPOSITIONS

Testosterone Cypionate-based drug compositions are designed to meet specific therapeutic needs. Common formulations include injectable forms tailored for intramuscular or subcutaneous administration, ensuring accurate dosing and efficacy.

INJECTABLE; INJECTION - 100MG/ML

This formulation of Testosterone Cypionate is ideal for individuals requiring precise doses. The 100mg/mL concentration allows for easy adjustment of dosage levels, making it suitable for a wide range of applications.

INJECTABLE; INJECTION - 200MG/ML

The 200mg/mL formulation is another popular option, providing higher doses for therapeutic purposes. It is commonly used in clinical settings to address conditions such as muscle wasting and severe testosterone deficiency.

RELATED EXCIPIENT COMPANIES

Exipient companies play a crucial role in the production of Testosterone Cypionate APIs. Major excipient suppliers include Nanjing Well Pharmaceutical, Actylis, Finar, TopChem Pharmaceuticals, and Zhejiang Xianju Pharmaceutical Co., among others. These companies provide essential raw materials and services to ensure API quality and reliability.

EXCIPIENTS BY APPLICATIONS

Exipients used in Testosterone Cypionate formulations vary based on their intended application. Common excipients include solubilizers and other additives designed to enhance bioavailability and stability of the API.

DIGITAL CONTENT

Stay updated with the latest news and advancements in pharmaceutical manufacturing through resources like #PharmaBuzz. This digital platform provides real-time updates and insights into the API industry, including developments related to Testosterone Cypionate.

GLOBAL SALES INFORMATION

To access global sales information on Testosterone Cypionate APIs, you can refer to platforms like US Medicaid Prescriptions and Regulatory FDF Prices. These resources provide insights into market trends and purchasing patterns.

MARKET PLACE

The API market is a dynamic and competitive landscape. Players such as APIs, Trifarma, Steroid SpA, and Fujifilm Diosynth Biotechnologies are key participants in the production and supply of Testosterone Cypionate APIs.

PATENTS & EXCLUSIVITIES

Patents and exclusivities play a significant role in the lifecycle of Testosterone Cypionate. Ensuring compliance with intellectual property laws is essential for manufacturers and suppliers to maintain competitive advantage in the market.

REF. STANDARDS & IMPURITIES

Reference standards and impurities are critical aspects in the production of Testosterone Cypionate APIs. Adherence to standards such as USP ensures the consistency and quality of the final product.

Filters

In pharmaceutical manufacturing, filters are essential for ensuring the purity and safety of APIs like Testosterone Cypionate. High-quality filters from companies like Aspen API and Symbiotec Pharmalab are commonly used in production processes.