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EU WC
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VMF
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Europe
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Canada
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API SUPPLIERS
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Nanjing Well Pharmaceutical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral, Topical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Application : Parenteral
Excipient Details : Histidine is used in biotherapeutic formulations and protects monoclonal antibodies in both the liquid and lyophilized state.
Pharmacopoeia Ref : USP, EP, BP, JP, ChP
Technical Specs : pH 7.4
Ingredient(s) : L-Histidine Excipient
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Hyaluronidase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyaluronidase, including repackagers and relabelers. The FDA regulates Hyaluronidase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyaluronidase 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 Hyaluronidase manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hyaluronidase supplier is an individual or a company that provides Hyaluronidase active pharmaceutical ingredient (API) or Hyaluronidase finished formulations upon request. The Hyaluronidase suppliers may include Hyaluronidase API manufacturers, exporters, distributors and traders.
click here to find a list of Hyaluronidase suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hyaluronidase DMF (Drug Master File) is a document detailing the whole manufacturing process of Hyaluronidase active pharmaceutical ingredient (API) in detail. Different forms of Hyaluronidase DMFs exist exist since differing nations have different regulations, such as Hyaluronidase USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hyaluronidase DMF submitted to regulatory agencies in the US is known as a USDMF. Hyaluronidase USDMF includes data on Hyaluronidase's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hyaluronidase USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hyaluronidase 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 Hyaluronidase Drug Master File in Japan (Hyaluronidase JDMF) empowers Hyaluronidase 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 Hyaluronidase JDMF during the approval evaluation for pharmaceutical products. At the time of Hyaluronidase 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 Hyaluronidase 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 Hyaluronidase Drug Master File in Korea (Hyaluronidase KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hyaluronidase. The MFDS reviews the Hyaluronidase KDMF as part of the drug registration process and uses the information provided in the Hyaluronidase KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hyaluronidase 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 Hyaluronidase API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hyaluronidase suppliers with KDMF on PharmaCompass.
A Hyaluronidase CEP of the European Pharmacopoeia monograph is often referred to as a Hyaluronidase Certificate of Suitability (COS). The purpose of a Hyaluronidase CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hyaluronidase EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hyaluronidase to their clients by showing that a Hyaluronidase CEP has been issued for it. The manufacturer submits a Hyaluronidase CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hyaluronidase CEP holder for the record. Additionally, the data presented in the Hyaluronidase CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hyaluronidase DMF.
A Hyaluronidase CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hyaluronidase 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 Hyaluronidase 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 Hyaluronidase as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hyaluronidase 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 Hyaluronidase 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 Hyaluronidase and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hyaluronidase NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hyaluronidase suppliers with NDC on PharmaCompass.
Hyaluronidase 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 Hyaluronidase 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 Hyaluronidase GMP manufacturer or Hyaluronidase GMP API supplier for your needs.
A Hyaluronidase CoA (Certificate of Analysis) is a formal document that attests to Hyaluronidase's compliance with Hyaluronidase specifications and serves as a tool for batch-level quality control.
Hyaluronidase CoA mostly includes findings from lab analyses of a specific batch. For each Hyaluronidase 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.
Hyaluronidase may be tested according to a variety of international standards, such as European Pharmacopoeia (Hyaluronidase EP), Hyaluronidase JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hyaluronidase USP).
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