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API SUPPLIERS
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Axplora- The partner of choice for complex APIs.
KDMF
EU 
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JDMF
Axplora- The partner of choice for complex APIs.
Registration Number : 221MF10010
Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy
Initial Date of Registration : 2009-01-13
Latest Date of Registration : 2009-01-13
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ANALYTICAL
ABOUT THIS PAGE
A Prednisolone Valerate Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prednisolone Valerate Acetate, including repackagers and relabelers. The FDA regulates Prednisolone Valerate Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prednisolone Valerate 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 Prednisolone Valerate Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prednisolone Valerate Acetate supplier is an individual or a company that provides Prednisolone Valerate Acetate active pharmaceutical ingredient (API) or Prednisolone Valerate Acetate finished formulations upon request. The Prednisolone Valerate Acetate suppliers may include Prednisolone Valerate Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Prednisolone Valerate Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Prednisolone Valerate Acetate Drug Master File in Japan (Prednisolone Valerate Acetate JDMF) empowers Prednisolone Valerate 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 Prednisolone Valerate Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Prednisolone Valerate 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 Prednisolone Valerate 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 Prednisolone Valerate Acetate Drug Master File in Korea (Prednisolone Valerate Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prednisolone Valerate Acetate. The MFDS reviews the Prednisolone Valerate Acetate KDMF as part of the drug registration process and uses the information provided in the Prednisolone Valerate Acetate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Prednisolone Valerate 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 Prednisolone Valerate Acetate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Prednisolone Valerate Acetate suppliers with KDMF on PharmaCompass.
Prednisolone Valerate 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 Prednisolone Valerate 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 Prednisolone Valerate Acetate GMP manufacturer or Prednisolone Valerate Acetate GMP API supplier for your needs.
A Prednisolone Valerate Acetate CoA (Certificate of Analysis) is a formal document that attests to Prednisolone Valerate Acetate's compliance with Prednisolone Valerate Acetate specifications and serves as a tool for batch-level quality control.
Prednisolone Valerate Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Prednisolone Valerate 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.
Prednisolone Valerate Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Prednisolone Valerate Acetate EP), Prednisolone Valerate Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prednisolone Valerate Acetate USP).
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