Synopsis
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CEP/COS
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JDMF
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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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Australia
DRUG PRODUCT COMPOSITIONS0
FDF
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Aspen API. More than just an API™
Click Us!
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Androst Biotech delivering high-quality hormone APIs and intermediates with trusted global compliance and competitive excellence.
Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.
Cerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.
Axplora is your partner of choice for complex APIs.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
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USDMF
Aspen API. More than just an API™
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-17
Pay. Date : 2014-02-06
DMF Number : 3857
Submission : 1980-05-21
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-30
Pay. Date : 2015-05-15
DMF Number : 29023
Submission : 2015-01-20
Status :
Type : II
Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-30
Pay. Date : 2017-07-03
DMF Number : 31860
Submission : 2017-08-18
Status :
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42305
Submission : 2025-07-22
Status :
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3220
Submission : 1978-06-14
Status :
Type : II
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-06
Pay. Date : 2013-02-14
DMF Number : 4245
Submission : 1981-08-13
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Date of Issue : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm : 385/2, Gram Pigdamber, Rau, Indore-453331, M.P., India
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162Amended
Address of the Firm : Plot No. 5,6,7 & 8, Special Economic Zone, Phase II, Pharma Zone, Pithampur, Dis...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Date of Issue : 2022-07-23
Valid Till : 2025-02-07
Written Confirmation Number : WC-0162n
Address of the Firm : Plot No-5,6,7 & 8, Special Economic Zone, Phase-II, Pharma Zone, Pithampur, Dist...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Aspen API. More than just an API™
About the Company : Aspen API is a cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. The company supplies a broad portfolio of over 50 high-qual...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, based in Indore, India, is a leading API manufacturer specializing in cortico-steroids and steroid-hormone APIs since 1995. Focused on R&D, sustainability, and innovatio...
Androst Biotech delivering high-quality hormone APIs and intermediates with trusted global compliance and competitive excellence.
About the Company : Androst Biotech India Private Limited (ABIPL) is a fast-growing manufacturer of Active Pharmaceutical Ingredients and intermediates, specializing in high-volume hormone production....
Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.
About the Company : Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners tur...
Cerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.
About the Company : Cerata Pharmaceuticals LLP is a WHO-GMP certified pharmaceutical API manufacturer based in Gujarat, India. We specialize in the development and manufacturing of high-quality APIs a...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
About the Company : Pfizer CentreOne® is an altogether different global contract development and manufacturing organization (CDMO), and a leading supplier of specialty APIs and intermediates.
...
Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
About the Company : Symbiotica is a Malaysia-based manufacturer of high-quality Active Pharmaceutical Ingredients (APIs), specialising in steroidal, hormonal, and niche non-steroidal compounds for glo...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - 100MG/ML
USFDA APPLICATION NUMBER - 85635
DOSAGE - INJECTABLE;INJECTION - 200MG/ML
USFDA APPLICATION NUMBER - 85635
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Parenteral
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Global Sales Information
US Medicaid Prescriptions
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ABOUT THIS PAGE
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PharmaCompass offers a list of Testosterone Cypionate 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 Cypionate manufacturer or Testosterone Cypionate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Testosterone Cypionate manufacturer or Testosterone Cypionate supplier.
PharmaCompass also assists you with knowing the Testosterone Cypionate API Price utilized in the formulation of products. Testosterone Cypionate API Price is not always fixed or binding as the Testosterone Cypionate Price is obtained through a variety of data sources. The Testosterone Cypionate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Testosterone 17 Beta-Cypionate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Testosterone 17 Beta-Cypionate, including repackagers and relabelers. The FDA regulates Testosterone 17 Beta-Cypionate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Testosterone 17 Beta-Cypionate 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 17 Beta-Cypionate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Testosterone 17 Beta-Cypionate supplier is an individual or a company that provides Testosterone 17 Beta-Cypionate active pharmaceutical ingredient (API) or Testosterone 17 Beta-Cypionate finished formulations upon request. The Testosterone 17 Beta-Cypionate suppliers may include Testosterone 17 Beta-Cypionate API manufacturers, exporters, distributors and traders.
click here to find a list of Testosterone 17 Beta-Cypionate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Testosterone 17 Beta-Cypionate DMF (Drug Master File) is a document detailing the whole manufacturing process of Testosterone 17 Beta-Cypionate active pharmaceutical ingredient (API) in detail. Different forms of Testosterone 17 Beta-Cypionate DMFs exist exist since differing nations have different regulations, such as Testosterone 17 Beta-Cypionate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Testosterone 17 Beta-Cypionate DMF submitted to regulatory agencies in the US is known as a USDMF. Testosterone 17 Beta-Cypionate USDMF includes data on Testosterone 17 Beta-Cypionate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Testosterone 17 Beta-Cypionate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Testosterone 17 Beta-Cypionate suppliers with USDMF on PharmaCompass.
A Testosterone 17 Beta-Cypionate written confirmation (Testosterone 17 Beta-Cypionate WC) is an official document issued by a regulatory agency to a Testosterone 17 Beta-Cypionate manufacturer, verifying that the manufacturing facility of a Testosterone 17 Beta-Cypionate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Testosterone 17 Beta-Cypionate APIs or Testosterone 17 Beta-Cypionate finished pharmaceutical products to another nation, regulatory agencies frequently require a Testosterone 17 Beta-Cypionate WC (written confirmation) as part of the regulatory process.
click here to find a list of Testosterone 17 Beta-Cypionate suppliers with Written Confirmation (WC) on PharmaCompass.
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 17 Beta-Cypionate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Testosterone 17 Beta-Cypionate API and other APIs are published in this directory by the FDA.
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 17 Beta-Cypionate 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.
The NDC directory also contains data on finished compounded human drug products that contain Testosterone 17 Beta-Cypionate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Testosterone 17 Beta-Cypionate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Testosterone 17 Beta-Cypionate suppliers with NDC on PharmaCompass.
Testosterone 17 Beta-Cypionate 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 17 Beta-Cypionate 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 17 Beta-Cypionate GMP manufacturer or Testosterone 17 Beta-Cypionate GMP API supplier for your needs.
A Testosterone 17 Beta-Cypionate CoA (Certificate of Analysis) is a formal document that attests to Testosterone 17 Beta-Cypionate's compliance with Testosterone 17 Beta-Cypionate specifications and serves as a tool for batch-level quality control.
Testosterone 17 Beta-Cypionate CoA mostly includes findings from lab analyses of a specific batch. For each Testosterone 17 Beta-Cypionate 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 17 Beta-Cypionate may be tested according to a variety of international standards, such as European Pharmacopoeia (Testosterone 17 Beta-Cypionate EP), Testosterone 17 Beta-Cypionate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Testosterone 17 Beta-Cypionate USP).
