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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
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Parenteral
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Nafarelin Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nafarelin Acetate, including repackagers and relabelers. The FDA regulates Nafarelin Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nafarelin 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 Nafarelin Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nafarelin Acetate supplier is an individual or a company that provides Nafarelin Acetate active pharmaceutical ingredient (API) or Nafarelin Acetate finished formulations upon request. The Nafarelin Acetate suppliers may include Nafarelin Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Nafarelin Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nafarelin Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Nafarelin Acetate active pharmaceutical ingredient (API) in detail. Different forms of Nafarelin Acetate DMFs exist exist since differing nations have different regulations, such as Nafarelin Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nafarelin Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Nafarelin Acetate USDMF includes data on Nafarelin Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nafarelin Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nafarelin 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 Nafarelin Acetate Drug Master File in Japan (Nafarelin Acetate JDMF) empowers Nafarelin 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 Nafarelin Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Nafarelin 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 Nafarelin Acetate suppliers with JDMF 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 Nafarelin Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nafarelin 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 Nafarelin 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 Nafarelin Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nafarelin Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nafarelin Acetate suppliers with NDC on PharmaCompass.
Nafarelin 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 Nafarelin 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 Nafarelin Acetate GMP manufacturer or Nafarelin Acetate GMP API supplier for your needs.
A Nafarelin Acetate CoA (Certificate of Analysis) is a formal document that attests to Nafarelin Acetate's compliance with Nafarelin Acetate specifications and serves as a tool for batch-level quality control.
Nafarelin Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Nafarelin 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.
Nafarelin Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Nafarelin Acetate EP), Nafarelin Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nafarelin Acetate USP).
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