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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 is a one-stop supplier of sodium hyaluronate//drug manufacturing license, CEP, GMP, DMF, and Form 41 certifications.
CEP/COS
EU-WC
NDC
KDMF
Kikkoman Biochemifa Company advances global health and safety through precision-driven innovation in biotech and food testing.
CEP/COS
KDMF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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
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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 : 42239
Submission : 2025-07-30
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 : 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 : 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 : 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 : 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
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 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 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 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, 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, 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, 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, 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, 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 1.4 M3/k...
Certificate Number : R1-CEP 2016-172 - Rev 00
Status : Valid
Issue Date : 2023-05-02
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, HA-E2.0 (intrinsic Viscosity...
Certificate Number : CEP 2015-200 - Rev 01
Status : Valid
Issue Date : 2024-03-05
Type : Chemical
Substance Number : 1472
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Purified sodium hyaluronate JP-AE
Registration Number : 304MF10049
Registrant's Address : No. 678 Tianchen St. , High-Tech Development Zone, Jinan 250101 P. R. China
Initial Date of Registration : 2022-03-02
Latest Date of Registration : 2024-02-07
Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.
Registration Number : 217MF10439
Registrant's Address : 1-4-13 Shibuya, Shibuya-ku, Tokyo
Initial Date of Registration : 2005-08-19
Latest Date of Registration : 2007-05-24
Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.
Registration Number : 227MF10163
Registrant's Address : 1-4-13 Shibuya, Shibuya-ku, Tokyo
Initial Date of Registration : 2015-06-18
Latest Date of Registration : 2015-06-18
Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.
Registration Number : 217MF10438
Registrant's Address : 1-4-13 Shibuya, Shibuya-ku, Tokyo
Initial Date of Registration : 2005-08-19
Latest Date of Registration : 2009-11-24
Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.
Registration Number : 228MF10141
Registrant's Address : 1-4-13 Shibuya, Shibuya-ku, Tokyo
Initial Date of Registration : 2016-08-02
Latest Date of Registration : 2016-08-02
Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.
Registration Number : 217MF10440
Registrant's Address : 1-4-13 Shibuya, Shibuya-ku, Tokyo
Initial Date of Registration : 2005-08-19
Latest Date of Registration : 2010-04-01
HTL Biotechnology is a French biotech & a global leader in the responsible development & production of pharma-grade biopolymers.
Registration Number : 228MF10072
Registrant's Address : 7 rue Alfred Kastler-ZI de l'Aumaillerie-35133 JAVENE-France
Initial Date of Registration : 2016-03-07
Latest Date of Registration : 2023-09-13
HTL Biotechnology is a French biotech & a global leader in the responsible development & production of pharma-grade biopolymers.
Purified sodium hyaluronate HMw
Registration Number : 230MF10061
Registrant's Address : 7 rue Alfred Kastler-ZI de l'Aumaillerie-35133 JAVENE-France
Initial Date of Registration : 2018-05-08
Latest Date of Registration : 2018-05-08
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
HyluMed Sterile HMW Sodium Hyaluronate
Registration Number : 222MF10066
Registrant's Address : 450 Water Street, Cambridge, MA 02141, USA
Initial Date of Registration : 2010-02-22
Latest Date of Registration : 2025-08-21
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
HyluMed Sterile Sodium Hyaluronate
Registration Number : 220MF10251
Registrant's Address : 500 Kendall Street, Cambridge, Massachusetts 02142, U.S. S. A.
Initial Date of Registration : 2008-12-11
Latest Date of Registration : 2008-12-11
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 is a one-stop supplier of sodium hyaluronate//drug manufacturing license, CEP, GMP, DMF, and Form 41 certifications.
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]KDMF
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2017-12-08
Registration Number : 20151016-96-E-123-38(6)
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No. 678 Tianchen St., High-Tech Development Zone, Jian City, Shandong Province, PR of...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : MFC Corporation
Registration Date : 2019-11-11
Registration Number : 20130322-96-E-109-34(B)
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No.678, Tianchen St., High-Tech Development Zone, Jinan, city, Shandong Province Chin...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : Unimed Pharmaceutical Co., Ltd.
Registration Date : 2022-09-02
Registration Number : 20211021-96-E-171-54(2)
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No 678, Tianchen St., High-Tech Development Zone, Jinan, Shandong province, China
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : Vinkorea
Registration Date : 2026-02-13
Registration Number : 20260213-96-E-194-70
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No 678, Tianchen St., High-Tech Development Zone, Jinan City, Shandong Province, PR o...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : Leaders Bio Co., Ltd.
Registration Date : 2025-05-16
Registration Number : 20130322-96-E-109-34(D)
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No 678, Tianchen St., High-Tech Development Zone, Jinan City, Shandong Province, PR o...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : Leaders Bio Co., Ltd.
Registration Date : 2025-05-16
Registration Number : 20211021-96-E-171-54(B)
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No 678, Tianchen St., High-Tech Development Zone, Jinan City, Shandong Province, PR o...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : Seongyi Bio Co., Ltd.
Registration Date : 2019-03-06
Registration Number : 20190306-96-E-150-45
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No.678, Tianchen St., High-Tech Development Zone, Jinan, City, Shondong Province, PRo...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : Unimed Pharmaceutical Co., Ltd.
Registration Date : 2022-03-23
Registration Number : 20130322-96-E-109-34(A)
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No. 678 Tianchen St., High-Tech Development Zone, Jian City, Shandong Province, PR of...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : Hiple Co., Ltd.
Registration Date : 2022-07-08
Registration Number : 20130322-96-E-109-34(C)
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No 678, Tianchen St., High-Tech Development Zone, Jinan City, Shandong Province, Chin...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : Hiple Co., Ltd.
Registration Date : 2022-07-08
Registration Number : 20211021-96-E-171-54(A)
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No. 678 Tianchen Street, High-Tech Development Zone, Jinan, China.
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]VMF
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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 is a global leader in bioactive materials, including mucopolysaccharides, proteins, peptides, amino acids, and natural compounds. It was ...
Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.
About the Company : Kewpie, the leading Japanese manufacturer of pharmaceutical-grade Sodium hyaluronate, first developed it in 1983. Its products are used as APIs and excipients for injections, eye d...
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 specializing in the development and production of pharmaceutical-grade Hyaluronic Acid (Sodium Hyaluronate) and functional biopolymers such as PDRN a...
Topscience Biotech is a one-stop supplier of sodium hyaluronate//drug manufacturing license, CEP, GMP, DMF, and Form 41 certifications.
About the Company : Topscience Biotechnology, founded in 2005, is a pioneer in sterile sodium hyaluronate raw materials in China, leading industry development through innovation. It offers sodium hyal...
Kikkoman Biochemifa Company advances global health and safety through precision-driven innovation in biotech and food testing.
About the Company : Kikkoman Biochemifa, a core division of Kikkoman Corporation, produces pharmaceuticals, enzymes, specialty chemicals, and advanced food safety systems. ISO certified, it offers fas...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Established in 1991, Pharm-Rx is an importer and distributor of active ingredients serving the pharmaceutical, nutritional supplement, and food industries. The company follows a hi...
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]Drugs in Development
Lead Product(s) : Sodium Hyaluronate,Inapplicable
Therapeutic Area : Trauma (Emergency, Injury, Surgery)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Lumenis
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 10, 2023
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
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Deregistered
Registration Country : Sweden
Sodium Hyaluronate (Crosslinked); Sodium Hyaluronate-Vinyl Sulfone, Crosslinked
Brand Name : Synvisc
Dosage Form : Injectable Solution
Dosage Strength : 8mg/ml
Packaging :
Approval Date : 15-03-1995
Application Number : 2.00E+13
Regulatory Info : Deregistered
Registration Country : Sweden
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
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ABOUT THIS PAGE
92
PharmaCompass offers a list of Sodium Hyaluronate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
A Hyalart manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyalart, including repackagers and relabelers. The FDA regulates Hyalart manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyalart 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 Hyalart manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Hyalart supplier is an individual or a company that provides Hyalart active pharmaceutical ingredient (API) or Hyalart finished formulations upon request. The Hyalart suppliers may include Hyalart API manufacturers, exporters, distributors and traders.
click here to find a list of Hyalart suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Hyalart DMF (Drug Master File) is a document detailing the whole manufacturing process of Hyalart active pharmaceutical ingredient (API) in detail. Different forms of Hyalart DMFs exist exist since differing nations have different regulations, such as Hyalart USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hyalart DMF submitted to regulatory agencies in the US is known as a USDMF. Hyalart USDMF includes data on Hyalart's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hyalart USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hyalart 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 Hyalart Drug Master File in Japan (Hyalart JDMF) empowers Hyalart 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 Hyalart JDMF during the approval evaluation for pharmaceutical products. At the time of Hyalart 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 Hyalart 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 Hyalart Drug Master File in Korea (Hyalart KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hyalart. The MFDS reviews the Hyalart KDMF as part of the drug registration process and uses the information provided in the Hyalart KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hyalart 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 Hyalart API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hyalart suppliers with KDMF on PharmaCompass.
A Hyalart CEP of the European Pharmacopoeia monograph is often referred to as a Hyalart Certificate of Suitability (COS). The purpose of a Hyalart CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hyalart EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hyalart to their clients by showing that a Hyalart CEP has been issued for it. The manufacturer submits a Hyalart CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hyalart CEP holder for the record. Additionally, the data presented in the Hyalart CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hyalart DMF.
A Hyalart CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hyalart 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 Hyalart suppliers with CEP (COS) on PharmaCompass.
A Hyalart written confirmation (Hyalart WC) is an official document issued by a regulatory agency to a Hyalart manufacturer, verifying that the manufacturing facility of a Hyalart active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hyalart APIs or Hyalart finished pharmaceutical products to another nation, regulatory agencies frequently require a Hyalart WC (written confirmation) as part of the regulatory process.
click here to find a list of Hyalart 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 Hyalart as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hyalart 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 Hyalart 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 Hyalart and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hyalart NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hyalart suppliers with NDC on PharmaCompass.
Hyalart 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 Hyalart GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Hyalart GMP manufacturer or Hyalart GMP API supplier for your needs.
A Hyalart CoA (Certificate of Analysis) is a formal document that attests to Hyalart's compliance with Hyalart specifications and serves as a tool for batch-level quality control.
Hyalart CoA mostly includes findings from lab analyses of a specific batch. For each Hyalart 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.
Hyalart may be tested according to a variety of international standards, such as European Pharmacopoeia (Hyalart EP), Hyalart JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hyalart USP).
