API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
0
Europe
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
76
PharmaCompass offers a list of Aspartic Acid API 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 Aspartic Acid API manufacturer or Aspartic Acid API supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aspartic Acid API manufacturer or Aspartic Acid API supplier.
PharmaCompass also assists you with knowing the Aspartic Acid API API Price utilized in the formulation of products. Aspartic Acid API API Price is not always fixed or binding as the Aspartic Acid API Price is obtained through a variety of data sources. The Aspartic Acid API Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A l-aspartic-acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of l-aspartic-acid, including repackagers and relabelers. The FDA regulates l-aspartic-acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. l-aspartic-acid 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 l-aspartic-acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A l-aspartic-acid supplier is an individual or a company that provides l-aspartic-acid active pharmaceutical ingredient (API) or l-aspartic-acid finished formulations upon request. The l-aspartic-acid suppliers may include l-aspartic-acid API manufacturers, exporters, distributors and traders.
click here to find a list of l-aspartic-acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A l-aspartic-acid DMF (Drug Master File) is a document detailing the whole manufacturing process of l-aspartic-acid active pharmaceutical ingredient (API) in detail. Different forms of l-aspartic-acid DMFs exist exist since differing nations have different regulations, such as l-aspartic-acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A l-aspartic-acid DMF submitted to regulatory agencies in the US is known as a USDMF. l-aspartic-acid USDMF includes data on l-aspartic-acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The l-aspartic-acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of l-aspartic-acid 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 l-aspartic-acid Drug Master File in Japan (l-aspartic-acid JDMF) empowers l-aspartic-acid 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 l-aspartic-acid JDMF during the approval evaluation for pharmaceutical products. At the time of l-aspartic-acid 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 l-aspartic-acid 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 l-aspartic-acid Drug Master File in Korea (l-aspartic-acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of l-aspartic-acid. The MFDS reviews the l-aspartic-acid KDMF as part of the drug registration process and uses the information provided in the l-aspartic-acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a l-aspartic-acid 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 l-aspartic-acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of l-aspartic-acid suppliers with KDMF on PharmaCompass.
A l-aspartic-acid CEP of the European Pharmacopoeia monograph is often referred to as a l-aspartic-acid Certificate of Suitability (COS). The purpose of a l-aspartic-acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of l-aspartic-acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of l-aspartic-acid to their clients by showing that a l-aspartic-acid CEP has been issued for it. The manufacturer submits a l-aspartic-acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a l-aspartic-acid CEP holder for the record. Additionally, the data presented in the l-aspartic-acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the l-aspartic-acid DMF.
A l-aspartic-acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. l-aspartic-acid 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 l-aspartic-acid suppliers with CEP (COS) on PharmaCompass.
l-aspartic-acid 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 l-aspartic-acid 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 l-aspartic-acid GMP manufacturer or l-aspartic-acid GMP API supplier for your needs.
A l-aspartic-acid CoA (Certificate of Analysis) is a formal document that attests to l-aspartic-acid's compliance with l-aspartic-acid specifications and serves as a tool for batch-level quality control.
l-aspartic-acid CoA mostly includes findings from lab analyses of a specific batch. For each l-aspartic-acid 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.
l-aspartic-acid may be tested according to a variety of international standards, such as European Pharmacopoeia (l-aspartic-acid EP), l-aspartic-acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (l-aspartic-acid USP).