API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
0
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
97
PharmaCompass offers a list of Lactic Acid 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 Lactic Acid manufacturer or Lactic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lactic Acid manufacturer or Lactic Acid supplier.
PharmaCompass also assists you with knowing the Lactic Acid API Price utilized in the formulation of products. Lactic Acid API Price is not always fixed or binding as the Lactic Acid Price is obtained through a variety of data sources. The Lactic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 09578_FLUKA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 09578_FLUKA, including repackagers and relabelers. The FDA regulates 09578_FLUKA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 09578_FLUKA 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 09578_FLUKA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 09578_FLUKA supplier is an individual or a company that provides 09578_FLUKA active pharmaceutical ingredient (API) or 09578_FLUKA finished formulations upon request. The 09578_FLUKA suppliers may include 09578_FLUKA API manufacturers, exporters, distributors and traders.
click here to find a list of 09578_FLUKA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 09578_FLUKA DMF (Drug Master File) is a document detailing the whole manufacturing process of 09578_FLUKA active pharmaceutical ingredient (API) in detail. Different forms of 09578_FLUKA DMFs exist exist since differing nations have different regulations, such as 09578_FLUKA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 09578_FLUKA DMF submitted to regulatory agencies in the US is known as a USDMF. 09578_FLUKA USDMF includes data on 09578_FLUKA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 09578_FLUKA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 09578_FLUKA 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 09578_FLUKA Drug Master File in Japan (09578_FLUKA JDMF) empowers 09578_FLUKA 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 09578_FLUKA JDMF during the approval evaluation for pharmaceutical products. At the time of 09578_FLUKA 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 09578_FLUKA suppliers with JDMF on PharmaCompass.
09578_FLUKA 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 09578_FLUKA 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 09578_FLUKA GMP manufacturer or 09578_FLUKA GMP API supplier for your needs.
A 09578_FLUKA CoA (Certificate of Analysis) is a formal document that attests to 09578_FLUKA's compliance with 09578_FLUKA specifications and serves as a tool for batch-level quality control.
09578_FLUKA CoA mostly includes findings from lab analyses of a specific batch. For each 09578_FLUKA 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.
09578_FLUKA may be tested according to a variety of international standards, such as European Pharmacopoeia (09578_FLUKA EP), 09578_FLUKA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (09578_FLUKA USP).