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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Evonik
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
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ABOUT THIS PAGE
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PharmaCompass offers a list of Hyaluronidase 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 Hyaluronidase manufacturer or Hyaluronidase supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hyaluronidase manufacturer or Hyaluronidase supplier.
PharmaCompass also assists you with knowing the Hyaluronidase API Price utilized in the formulation of products. Hyaluronidase API Price is not always fixed or binding as the Hyaluronidase Price is obtained through a variety of data sources. The Hyaluronidase Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A WYDASE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of WYDASE, including repackagers and relabelers. The FDA regulates WYDASE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. WYDASE 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 WYDASE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A WYDASE supplier is an individual or a company that provides WYDASE active pharmaceutical ingredient (API) or WYDASE finished formulations upon request. The WYDASE suppliers may include WYDASE API manufacturers, exporters, distributors and traders.
click here to find a list of WYDASE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A WYDASE DMF (Drug Master File) is a document detailing the whole manufacturing process of WYDASE active pharmaceutical ingredient (API) in detail. Different forms of WYDASE DMFs exist exist since differing nations have different regulations, such as WYDASE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A WYDASE DMF submitted to regulatory agencies in the US is known as a USDMF. WYDASE USDMF includes data on WYDASE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The WYDASE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of WYDASE 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 WYDASE Drug Master File in Japan (WYDASE JDMF) empowers WYDASE 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 WYDASE JDMF during the approval evaluation for pharmaceutical products. At the time of WYDASE 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 WYDASE 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 WYDASE Drug Master File in Korea (WYDASE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of WYDASE. The MFDS reviews the WYDASE KDMF as part of the drug registration process and uses the information provided in the WYDASE KDMF to evaluate the safety and efficacy of the drug.
After submitting a WYDASE 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 WYDASE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of WYDASE suppliers with KDMF on PharmaCompass.
A WYDASE CEP of the European Pharmacopoeia monograph is often referred to as a WYDASE Certificate of Suitability (COS). The purpose of a WYDASE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of WYDASE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of WYDASE to their clients by showing that a WYDASE CEP has been issued for it. The manufacturer submits a WYDASE CEP (COS) as part of the market authorization procedure, and it takes on the role of a WYDASE CEP holder for the record. Additionally, the data presented in the WYDASE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the WYDASE DMF.
A WYDASE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. WYDASE 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 WYDASE suppliers with CEP (COS) 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 WYDASE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for WYDASE 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 WYDASE 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 WYDASE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a WYDASE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of WYDASE suppliers with NDC on PharmaCompass.
WYDASE 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 WYDASE 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 WYDASE GMP manufacturer or WYDASE GMP API supplier for your needs.
A WYDASE CoA (Certificate of Analysis) is a formal document that attests to WYDASE's compliance with WYDASE specifications and serves as a tool for batch-level quality control.
WYDASE CoA mostly includes findings from lab analyses of a specific batch. For each WYDASE 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.
WYDASE may be tested according to a variety of international standards, such as European Pharmacopoeia (WYDASE EP), WYDASE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (WYDASE USP).
