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API SUPPLIERS
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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 : 26039
Submission : 2012-05-07
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, Intrinsic Viscosity 2.5 M3/k...
Certificate Number : CEP 2017-195 - Rev 01
Status : Valid
Issue Date : 2024-05-02
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, Intrinsic Viscosity 3.8 M3/k...
Certificate Number : R0-CEP 2022-129 - Rev 01
Status : Valid
Issue Date : 2023-05-31
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, Intrinsic Viscosity 1.8 M3/k...
Certificate Number : CEP 2021-220 - Rev 02
Status : Valid
Issue Date : 2024-06-12
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, Intrinsic Viscosity 0.6 M3/k...
Certificate Number : R0-CEP 2021-446 - Rev 01
Status : Valid
Issue Date : 2023-06-15
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, HA-EP 1.8 (intrinsic Viscosi...
Certificate Number : CEP 2010-289 - Rev 04
Status : Valid
Issue Date : 2023-09-15
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, HA-E3.0 (intrinsic Viscosity...
Certificate Number : R1-CEP 2015-201 - Rev 00
Status : Valid
Issue Date : 2021-11-05
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, Intrinsic Viscosity 2.4 M3/k...
Certificate Number : CEP 2018-107 - Rev 04
Status : Valid
Issue Date : 2024-02-19
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, Intrinsic Viscosity 1.25 M3/...
Certificate Number : R0-CEP 2021-258 - Rev 02
Status : Valid
Issue Date : 2023-03-08
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, HA-E2.0 (intrinsic Viscosity...
Certificate Number : CEP 2015-200 - Rev 01
Status : Valid
Issue Date : 2024-03-05
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, Intrinsic Viscosity 1.4 M3/k...
Certificate Number : R1-CEP 2016-172 - Rev 00
Status : Valid
Issue Date : 2023-05-02
Type : Chemical
Substance Number : 1472
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
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
About the Company : Bloomage Biotechnology Corporation Limited, formerly Bloomage Freda Biopharm, was established by Bloomage International Investment Group. It is a global leader in bioactive materia...
Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.
About the Company : Kewpie first developed Sodium hyaluronate in 1983 and is currently the leading Japanese manufacturer of pharmaceutical grade Sodium hyaluronate used as an API and pharmaceutical ex...
HTL Biotechnology is a French biotech & a global leader in the responsible development & production of pharma-grade biopolymers.
About the Company : HTL is a biotechnology company pioneering the development and production of pharmaceutical-grade Hyaluronic Acid (Sodium Hyaluronate) and other functional biopolymers such as PDRN ...
Topscience Biotech specializes in R&D, production, and sales of Sodium Hyaluronate, focusing on Medical and Pharmaceutical Grade HA.
About the Company : Established in 2005, Topscience located in Lanshan, Rizhao of PRC and covers an area of 100,000m². Products include Sodium Hyaluronate, Chondroitin Sulfate, Alpha-Arbutin, L-Ascor...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
Basic Nutrition, your expert for sourcing from China, India and Europe.
About the Company : As an ISO9001, ISO22000 certificated supplier, Basic Nutrition supply high-quality ingredients for nutraceuticals. We can offer a range of products from small to large quantites: h...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
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Drugs in Development
Lead Product(s) : Sodium Hyaluronate
Therapeutic Area : Trauma (Emergency, Injury, Surgery)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Lumenis
Deal Size : Not Applicable
Deal Type : Not Applicable
Lumenis and Bloomage Biotech jointly released a new product - M22 medical wound dressing
Details : M22 medical wound dressing (sodium hyaluronate) is a versatile laser treatment system based on Lumenis' medical beauty concept of "30% Laser Treatment and 70% Postoperative care.
Brand Name : M22 Medical Wound Dressing
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 10, 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet
Grade : Parenteral, Oral, Topical
Application : Parenteral, Solubilizers, Topical
Excipient Details : Benzyl alcohol is used as a bacteriostatic & preservative in parenteral & ophthalmic products. It is widely used in oral & topical formulations.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Solution, Tablet
Grade : Parenteral, Oral, Topical
Brand Name : Polyoxyethylene (35) Castor Oil
Application : Emulsifying Agents, Parenteral, Solubilizers, Surfactant & Foaming Agents, Topical
Excipient Details : Polyxyl 35 castor oil is used as surfactant & emulsifier in parenteral formulations. It acts as solubilizer & emulsifier in oral & topical products.
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Co-Processed Excipients
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Coating Systems & Additives
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ABOUT THIS PAGE
A Sodium Hyaluronate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Hyaluronate, including repackagers and relabelers. The FDA regulates Sodium Hyaluronate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Hyaluronate 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 Sodium Hyaluronate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Hyaluronate supplier is an individual or a company that provides Sodium Hyaluronate active pharmaceutical ingredient (API) or Sodium Hyaluronate finished formulations upon request. The Sodium Hyaluronate suppliers may include Sodium Hyaluronate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Hyaluronate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Hyaluronate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Hyaluronate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Hyaluronate DMFs exist exist since differing nations have different regulations, such as Sodium Hyaluronate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Hyaluronate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Hyaluronate USDMF includes data on Sodium Hyaluronate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Hyaluronate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Hyaluronate 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 Sodium Hyaluronate Drug Master File in Japan (Sodium Hyaluronate JDMF) empowers Sodium Hyaluronate 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 Sodium Hyaluronate JDMF during the approval evaluation for pharmaceutical products. At the time of Sodium Hyaluronate 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 Sodium Hyaluronate 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 Sodium Hyaluronate Drug Master File in Korea (Sodium Hyaluronate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sodium Hyaluronate. The MFDS reviews the Sodium Hyaluronate KDMF as part of the drug registration process and uses the information provided in the Sodium Hyaluronate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sodium Hyaluronate 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 Sodium Hyaluronate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sodium Hyaluronate suppliers with KDMF on PharmaCompass.
A Sodium Hyaluronate CEP of the European Pharmacopoeia monograph is often referred to as a Sodium Hyaluronate Certificate of Suitability (COS). The purpose of a Sodium Hyaluronate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sodium Hyaluronate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sodium Hyaluronate to their clients by showing that a Sodium Hyaluronate CEP has been issued for it. The manufacturer submits a Sodium Hyaluronate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sodium Hyaluronate CEP holder for the record. Additionally, the data presented in the Sodium Hyaluronate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sodium Hyaluronate DMF.
A Sodium Hyaluronate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sodium Hyaluronate 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 Sodium Hyaluronate suppliers with CEP (COS) on PharmaCompass.
A Sodium Hyaluronate written confirmation (Sodium Hyaluronate WC) is an official document issued by a regulatory agency to a Sodium Hyaluronate manufacturer, verifying that the manufacturing facility of a Sodium Hyaluronate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sodium Hyaluronate APIs or Sodium Hyaluronate finished pharmaceutical products to another nation, regulatory agencies frequently require a Sodium Hyaluronate WC (written confirmation) as part of the regulatory process.
click here to find a list of Sodium Hyaluronate 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 Sodium Hyaluronate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium Hyaluronate 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 Sodium Hyaluronate 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 Sodium Hyaluronate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium Hyaluronate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium Hyaluronate suppliers with NDC on PharmaCompass.
Sodium Hyaluronate 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 Sodium Hyaluronate 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 Sodium Hyaluronate GMP manufacturer or Sodium Hyaluronate GMP API supplier for your needs.
A Sodium Hyaluronate CoA (Certificate of Analysis) is a formal document that attests to Sodium Hyaluronate's compliance with Sodium Hyaluronate specifications and serves as a tool for batch-level quality control.
Sodium Hyaluronate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Hyaluronate 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.
Sodium Hyaluronate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Hyaluronate EP), Sodium Hyaluronate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Hyaluronate USP).
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