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Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
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Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
Axplora is your partner of choice for complex APIs.
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
CAS Number : 68-96-2
End Use API : Medroxyprogesterone Acetate
About The Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus...
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Regulatory Info :
Registration Country : Norway
Conjugated Estrogens; Medroxyprogesterone Acetate
Brand Name : Indivina
Dosage Form : Antic-calc Tablet
Dosage Strength : 1MG; 2.5MG
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Conjugated Estrogens; Medroxyprogesterone Acetate
Brand Name : Indivina
Dosage Form : Antic-calc Tablet
Dosage Strength : 1MG; 2.5MG
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Conjugated Estrogens; Medroxyprogesterone Acetate
Brand Name : Indivina
Dosage Form : Antic-calc Tablet
Dosage Strength : 01MG; 05MG
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Conjugated Estrogens; Medroxyprogesterone Acetate
Brand Name : Indivina
Dosage Form : Antic-calc Tablet
Dosage Strength : 02MG; 05MG
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 11839
DOSAGE - TABLET;ORAL - 2.5MG
USFDA APPLICATION NUMBER - 11839
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 11839
DOSAGE - INJECTABLE;INJECTION - 100MG/ML **Fe...DOSAGE - INJECTABLE;INJECTION - 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12541
DOSAGE - INJECTABLE;INJECTION - 400MG/ML
USFDA APPLICATION NUMBER - 12541
DOSAGE - INJECTABLE;INJECTION - 150MG/ML
USFDA APPLICATION NUMBER - 20246
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PharmaCompass offers a list of Medroxyprogesterone 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 Medroxyprogesterone Acetate manufacturer or Medroxyprogesterone Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Medroxyprogesterone Acetate manufacturer or Medroxyprogesterone Acetate supplier.
PharmaCompass also assists you with knowing the Medroxyprogesterone Acetate API Price utilized in the formulation of products. Medroxyprogesterone Acetate API Price is not always fixed or binding as the Medroxyprogesterone Acetate Price is obtained through a variety of data sources. The Medroxyprogesterone Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Depocon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Depocon, including repackagers and relabelers. The FDA regulates Depocon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Depocon 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 Depocon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Depocon supplier is an individual or a company that provides Depocon active pharmaceutical ingredient (API) or Depocon finished formulations upon request. The Depocon suppliers may include Depocon API manufacturers, exporters, distributors and traders.
click here to find a list of Depocon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Depocon DMF (Drug Master File) is a document detailing the whole manufacturing process of Depocon active pharmaceutical ingredient (API) in detail. Different forms of Depocon DMFs exist exist since differing nations have different regulations, such as Depocon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Depocon DMF submitted to regulatory agencies in the US is known as a USDMF. Depocon USDMF includes data on Depocon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Depocon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Depocon suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Depocon Drug Master File in Japan (Depocon JDMF) empowers Depocon API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Depocon JDMF during the approval evaluation for pharmaceutical products. At the time of Depocon JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Depocon suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Depocon Drug Master File in Korea (Depocon KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Depocon. The MFDS reviews the Depocon KDMF as part of the drug registration process and uses the information provided in the Depocon KDMF to evaluate the safety and efficacy of the drug.
After submitting a Depocon KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Depocon API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Depocon suppliers with KDMF on PharmaCompass.
A Depocon CEP of the European Pharmacopoeia monograph is often referred to as a Depocon Certificate of Suitability (COS). The purpose of a Depocon CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Depocon EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Depocon to their clients by showing that a Depocon CEP has been issued for it. The manufacturer submits a Depocon CEP (COS) as part of the market authorization procedure, and it takes on the role of a Depocon CEP holder for the record. Additionally, the data presented in the Depocon CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Depocon DMF.
A Depocon CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Depocon 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 Depocon suppliers with CEP (COS) 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 Depocon as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Depocon 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 Depocon 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 Depocon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Depocon NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Depocon suppliers with NDC on PharmaCompass.
Depocon 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 Depocon 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 Depocon GMP manufacturer or Depocon GMP API supplier for your needs.
A Depocon CoA (Certificate of Analysis) is a formal document that attests to Depocon's compliance with Depocon specifications and serves as a tool for batch-level quality control.
Depocon CoA mostly includes findings from lab analyses of a specific batch. For each Depocon 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.
Depocon may be tested according to a variety of international standards, such as European Pharmacopoeia (Depocon EP), Depocon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Depocon USP).
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