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PharmaCompass offers a list of Hydrocortisone Sodium Phosphate 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 Hydrocortisone Sodium Phosphate manufacturer or Hydrocortisone Sodium Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydrocortisone Sodium Phosphate manufacturer or Hydrocortisone Sodium Phosphate supplier.
PharmaCompass also assists you with knowing the Hydrocortisone Sodium Phosphate API Price utilized in the formulation of products. Hydrocortisone Sodium Phosphate API Price is not always fixed or binding as the Hydrocortisone Sodium Phosphate Price is obtained through a variety of data sources. The Hydrocortisone Sodium Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 0388G963HY manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 0388G963HY, including repackagers and relabelers. The FDA regulates 0388G963HY manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 0388G963HY 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 0388G963HY manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 0388G963HY supplier is an individual or a company that provides 0388G963HY active pharmaceutical ingredient (API) or 0388G963HY finished formulations upon request. The 0388G963HY suppliers may include 0388G963HY API manufacturers, exporters, distributors and traders.
click here to find a list of 0388G963HY suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 0388G963HY DMF (Drug Master File) is a document detailing the whole manufacturing process of 0388G963HY active pharmaceutical ingredient (API) in detail. Different forms of 0388G963HY DMFs exist exist since differing nations have different regulations, such as 0388G963HY USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 0388G963HY DMF submitted to regulatory agencies in the US is known as a USDMF. 0388G963HY USDMF includes data on 0388G963HY's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 0388G963HY USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 0388G963HY 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 0388G963HY Drug Master File in Japan (0388G963HY JDMF) empowers 0388G963HY 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 0388G963HY JDMF during the approval evaluation for pharmaceutical products. At the time of 0388G963HY JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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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 0388G963HY as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 0388G963HY 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 0388G963HY 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 0388G963HY and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 0388G963HY NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 0388G963HY suppliers with NDC on PharmaCompass.
0388G963HY 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 0388G963HY 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 0388G963HY GMP manufacturer or 0388G963HY GMP API supplier for your needs.
A 0388G963HY CoA (Certificate of Analysis) is a formal document that attests to 0388G963HY's compliance with 0388G963HY specifications and serves as a tool for batch-level quality control.
0388G963HY CoA mostly includes findings from lab analyses of a specific batch. For each 0388G963HY 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.
0388G963HY may be tested according to a variety of international standards, such as European Pharmacopoeia (0388G963HY EP), 0388G963HY JP (Japanese Pharmacopeia) and the US Pharmacopoeia (0388G963HY USP).
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