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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 Medroxyprogesterone Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Medroxyprogesterone Acetate, including repackagers and relabelers. The FDA regulates Medroxyprogesterone Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Medroxyprogesterone Acetate supplier is an individual or a company that provides Medroxyprogesterone Acetate active pharmaceutical ingredient (API) or Medroxyprogesterone Acetate finished formulations upon request. The Medroxyprogesterone Acetate suppliers may include Medroxyprogesterone Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Medroxyprogesterone Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Medroxyprogesterone Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Medroxyprogesterone Acetate active pharmaceutical ingredient (API) in detail. Different forms of Medroxyprogesterone Acetate DMFs exist exist since differing nations have different regulations, such as Medroxyprogesterone Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Medroxyprogesterone Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Medroxyprogesterone Acetate USDMF includes data on Medroxyprogesterone Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Medroxyprogesterone Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate Drug Master File in Japan (Medroxyprogesterone Acetate JDMF) empowers Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate Drug Master File in Korea (Medroxyprogesterone Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Medroxyprogesterone Acetate. The MFDS reviews the Medroxyprogesterone Acetate KDMF as part of the drug registration process and uses the information provided in the Medroxyprogesterone Acetate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Medroxyprogesterone Acetate suppliers with KDMF on PharmaCompass.
A Medroxyprogesterone Acetate CEP of the European Pharmacopoeia monograph is often referred to as a Medroxyprogesterone Acetate Certificate of Suitability (COS). The purpose of a Medroxyprogesterone Acetate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Medroxyprogesterone Acetate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Medroxyprogesterone Acetate to their clients by showing that a Medroxyprogesterone Acetate CEP has been issued for it. The manufacturer submits a Medroxyprogesterone Acetate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Medroxyprogesterone Acetate CEP holder for the record. Additionally, the data presented in the Medroxyprogesterone Acetate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Medroxyprogesterone Acetate DMF.
A Medroxyprogesterone Acetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Medroxyprogesterone Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Medroxyprogesterone Acetate suppliers with NDC on PharmaCompass.
Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate GMP manufacturer or Medroxyprogesterone Acetate GMP API supplier for your needs.
A Medroxyprogesterone Acetate CoA (Certificate of Analysis) is a formal document that attests to Medroxyprogesterone Acetate's compliance with Medroxyprogesterone Acetate specifications and serves as a tool for batch-level quality control.
Medroxyprogesterone Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Medroxyprogesterone Acetate 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.
Medroxyprogesterone Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Medroxyprogesterone Acetate EP), Medroxyprogesterone Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Medroxyprogesterone Acetate USP).
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