Synopsis
0
FDA Orange Book
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Click Us!
JDMF
EU-WC
NDC
KDMF
Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.
CEP/COS
JDMF
KDMF
CN
HTL Biotechnology is a French biotech & a global leader in the responsible development & production of pharma-grade biopolymers.
CEP/COS
JDMF
NDC
KDMF
Topscience Biotech specializes in R&D, production, and sales of Sodium Hyaluronate, focusing on Medical and Pharmaceutical Grade HA.
CEP/COS
EU-WC
NDC
KDMF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
KDMF
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Basic Nutrition, your expert for sourcing from China, India and Europe.
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
CEP/COS
NDC
KDMF
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
CEP/COS
KDMF
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
CEP/COS
KDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35878
Submission : 2021-05-11
Status :
Type : II
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24508
Submission : 2010-12-20
Status :
Type : II
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38333
Submission : 2023-05-08
Status :
Type : II
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27373
Submission : 2013-07-31
Status :
Type : II
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24507
Submission : 2010-12-20
Status :
Type : II
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38036
Submission : 2023-03-14
Status :
Type : II
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35998
Submission : 2021-06-06
Status :
Type : II
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26360
Submission : 2012-08-20
Status :
Type : II
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35899
Submission : 2021-04-29
Status :
Type : II
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26039
Submission : 2012-05-07
Status :
Type : II
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] EU WC
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Date of Issue : 2020-07-24
Valid Till : 2025-12-18
Written Confirmation Number : SD220043
Address of the Firm : No.678 Tianchen St., High-tech Development Zone, Jinan City, Shandong Province
Topscience Biotech specializes in R&D, production, and sales of Sodium Hyaluronate, focusing on Medical and Pharmaceutical Grade HA.
Date of Issue : 2022-12-06
Valid Till : 2025-12-18
Written Confirmation Number : SD220042
Address of the Firm : No 98, Lanshan West Road, Lanshan District, Rizhao City, Shandong Province-Post ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
EUROAPI
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Tablet
Grade : Oral
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Parenteral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
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]Corel Pharma Chem
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]Kerry
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
Topical
Solubilizers
Granulation
Co-Processed Excipients
Fillers, Diluents & Binders
Emulsifying Agents
Controlled & Modified Release
Direct Compression
Coating Systems & Additives
Taste Masking
API Stability Enhancers
Surfactant & Foaming Agents
Disintegrants & Superdisintegrants
Film Formers & Plasticizers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
68
PharmaCompass offers a list of Sodium Hyaluronate 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 Sodium Hyaluronate manufacturer or Sodium Hyaluronate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Hyaluronate manufacturer or Sodium Hyaluronate supplier.
PharmaCompass also assists you with knowing the Sodium Hyaluronate API Price utilized in the formulation of products. Sodium Hyaluronate API Price is not always fixed or binding as the Sodium Hyaluronate Price is obtained through a variety of data sources. The Sodium Hyaluronate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Orthovisc manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orthovisc, including repackagers and relabelers. The FDA regulates Orthovisc manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orthovisc 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 Orthovisc manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Orthovisc supplier is an individual or a company that provides Orthovisc active pharmaceutical ingredient (API) or Orthovisc finished formulations upon request. The Orthovisc suppliers may include Orthovisc API manufacturers, exporters, distributors and traders.
click here to find a list of Orthovisc suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Orthovisc DMF (Drug Master File) is a document detailing the whole manufacturing process of Orthovisc active pharmaceutical ingredient (API) in detail. Different forms of Orthovisc DMFs exist exist since differing nations have different regulations, such as Orthovisc USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Orthovisc DMF submitted to regulatory agencies in the US is known as a USDMF. Orthovisc USDMF includes data on Orthovisc's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Orthovisc USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Orthovisc 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 Orthovisc Drug Master File in Japan (Orthovisc JDMF) empowers Orthovisc 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 Orthovisc JDMF during the approval evaluation for pharmaceutical products. At the time of Orthovisc 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 Orthovisc 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 Orthovisc Drug Master File in Korea (Orthovisc KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Orthovisc. The MFDS reviews the Orthovisc KDMF as part of the drug registration process and uses the information provided in the Orthovisc KDMF to evaluate the safety and efficacy of the drug.
After submitting a Orthovisc 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 Orthovisc API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Orthovisc suppliers with KDMF on PharmaCompass.
A Orthovisc CEP of the European Pharmacopoeia monograph is often referred to as a Orthovisc Certificate of Suitability (COS). The purpose of a Orthovisc CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Orthovisc EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Orthovisc to their clients by showing that a Orthovisc CEP has been issued for it. The manufacturer submits a Orthovisc CEP (COS) as part of the market authorization procedure, and it takes on the role of a Orthovisc CEP holder for the record. Additionally, the data presented in the Orthovisc CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Orthovisc DMF.
A Orthovisc CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Orthovisc 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 Orthovisc suppliers with CEP (COS) on PharmaCompass.
A Orthovisc written confirmation (Orthovisc WC) is an official document issued by a regulatory agency to a Orthovisc manufacturer, verifying that the manufacturing facility of a Orthovisc active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Orthovisc APIs or Orthovisc finished pharmaceutical products to another nation, regulatory agencies frequently require a Orthovisc WC (written confirmation) as part of the regulatory process.
click here to find a list of Orthovisc suppliers with Written Confirmation (WC) 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 Orthovisc as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Orthovisc 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 Orthovisc 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 Orthovisc and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Orthovisc NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Orthovisc suppliers with NDC on PharmaCompass.
Orthovisc 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 Orthovisc 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 Orthovisc GMP manufacturer or Orthovisc GMP API supplier for your needs.
A Orthovisc CoA (Certificate of Analysis) is a formal document that attests to Orthovisc's compliance with Orthovisc specifications and serves as a tool for batch-level quality control.
Orthovisc CoA mostly includes findings from lab analyses of a specific batch. For each Orthovisc 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.
Orthovisc may be tested according to a variety of international standards, such as European Pharmacopoeia (Orthovisc EP), Orthovisc JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Orthovisc USP).
