Synopsis
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
FDF
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
0
News #PharmaBuzz
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Topical
Solubilizers
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
10
PharmaCompass offers a list of Gonadorelin 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 Gonadorelin Acetate manufacturer or Gonadorelin Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gonadorelin Acetate manufacturer or Gonadorelin Acetate supplier.
PharmaCompass also assists you with knowing the Gonadorelin Acetate API Price utilized in the formulation of products. Gonadorelin Acetate API Price is not always fixed or binding as the Gonadorelin Acetate Price is obtained through a variety of data sources. The Gonadorelin Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A LUTAL ACETATE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LUTAL ACETATE, including repackagers and relabelers. The FDA regulates LUTAL ACETATE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LUTAL 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 LUTAL ACETATE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A LUTAL ACETATE supplier is an individual or a company that provides LUTAL ACETATE active pharmaceutical ingredient (API) or LUTAL ACETATE finished formulations upon request. The LUTAL ACETATE suppliers may include LUTAL ACETATE API manufacturers, exporters, distributors and traders.
click here to find a list of LUTAL ACETATE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A LUTAL ACETATE DMF (Drug Master File) is a document detailing the whole manufacturing process of LUTAL ACETATE active pharmaceutical ingredient (API) in detail. Different forms of LUTAL ACETATE DMFs exist exist since differing nations have different regulations, such as LUTAL ACETATE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LUTAL ACETATE DMF submitted to regulatory agencies in the US is known as a USDMF. LUTAL ACETATE USDMF includes data on LUTAL ACETATE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LUTAL ACETATE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of LUTAL 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 LUTAL ACETATE Drug Master File in Japan (LUTAL ACETATE JDMF) empowers LUTAL 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 LUTAL ACETATE JDMF during the approval evaluation for pharmaceutical products. At the time of LUTAL 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 LUTAL 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 LUTAL ACETATE Drug Master File in Korea (LUTAL ACETATE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of LUTAL ACETATE. The MFDS reviews the LUTAL ACETATE KDMF as part of the drug registration process and uses the information provided in the LUTAL ACETATE KDMF to evaluate the safety and efficacy of the drug.
After submitting a LUTAL 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 LUTAL ACETATE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of LUTAL ACETATE suppliers with KDMF on PharmaCompass.
A LUTAL ACETATE CEP of the European Pharmacopoeia monograph is often referred to as a LUTAL ACETATE Certificate of Suitability (COS). The purpose of a LUTAL ACETATE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of LUTAL ACETATE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of LUTAL ACETATE to their clients by showing that a LUTAL ACETATE CEP has been issued for it. The manufacturer submits a LUTAL ACETATE CEP (COS) as part of the market authorization procedure, and it takes on the role of a LUTAL ACETATE CEP holder for the record. Additionally, the data presented in the LUTAL ACETATE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the LUTAL ACETATE DMF.
A LUTAL ACETATE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. LUTAL 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 LUTAL ACETATE suppliers with CEP (COS) on PharmaCompass.
A LUTAL ACETATE written confirmation (LUTAL ACETATE WC) is an official document issued by a regulatory agency to a LUTAL ACETATE manufacturer, verifying that the manufacturing facility of a LUTAL ACETATE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting LUTAL ACETATE APIs or LUTAL ACETATE finished pharmaceutical products to another nation, regulatory agencies frequently require a LUTAL ACETATE WC (written confirmation) as part of the regulatory process.
click here to find a list of LUTAL ACETATE 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 LUTAL ACETATE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for LUTAL 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 LUTAL 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 LUTAL ACETATE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a LUTAL ACETATE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of LUTAL ACETATE suppliers with NDC on PharmaCompass.
LUTAL 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 LUTAL 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 LUTAL ACETATE GMP manufacturer or LUTAL ACETATE GMP API supplier for your needs.
A LUTAL ACETATE CoA (Certificate of Analysis) is a formal document that attests to LUTAL ACETATE's compliance with LUTAL ACETATE specifications and serves as a tool for batch-level quality control.
LUTAL ACETATE CoA mostly includes findings from lab analyses of a specific batch. For each LUTAL 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.
LUTAL ACETATE may be tested according to a variety of international standards, such as European Pharmacopoeia (LUTAL ACETATE EP), LUTAL ACETATE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (LUTAL ACETATE USP).
