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