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API SUPPLIERS
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USDMF
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2020-05-19
Pay. Date : 2020-04-13
DMF Number : 32728
Submission : 2018-06-04
Status :
Type : II
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-29
Pay. Date : 2020-09-22
DMF Number : 32896
Submission : 2018-07-16
Status :
Type : II
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-01
Pay. Date : 2023-01-30
DMF Number : 3529
Submission : 1979-05-30
Status :
Type : II
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DOSAGE - SUSPENSION;OPHTHALMIC - 0.2%;10%
USFDA APPLICATION NUMBER - 12813
DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 1%
USFDA APPLICATION NUMBER - 17011
DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.12%
USFDA APPLICATION NUMBER - 17100
DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 1%
USFDA APPLICATION NUMBER - 17469
DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - EQ 0.3...DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - EQ 0.3% BASE;1%
USFDA APPLICATION NUMBER - 50586
DOSAGE - OINTMENT;OPHTHALMIC - EQ 0.3% BASE;0...DOSAGE - OINTMENT;OPHTHALMIC - EQ 0.3% BASE;0.6%
USFDA APPLICATION NUMBER - 50612
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PharmaCompass offers a list of Prednisolone Acetate 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 Prednisolone Acetate manufacturer or Prednisolone Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Prednisolone Acetate manufacturer or Prednisolone Acetate supplier.
PharmaCompass also assists you with knowing the Prednisolone Acetate API Price utilized in the formulation of products. Prednisolone Acetate API Price is not always fixed or binding as the Prednisolone Acetate Price is obtained through a variety of data sources. The Prednisolone Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Omnipred manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Omnipred, including repackagers and relabelers. The FDA regulates Omnipred manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Omnipred 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 Omnipred manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Omnipred supplier is an individual or a company that provides Omnipred active pharmaceutical ingredient (API) or Omnipred finished formulations upon request. The Omnipred suppliers may include Omnipred API manufacturers, exporters, distributors and traders.
click here to find a list of Omnipred suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Omnipred DMF (Drug Master File) is a document detailing the whole manufacturing process of Omnipred active pharmaceutical ingredient (API) in detail. Different forms of Omnipred DMFs exist exist since differing nations have different regulations, such as Omnipred USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Omnipred DMF submitted to regulatory agencies in the US is known as a USDMF. Omnipred USDMF includes data on Omnipred's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Omnipred USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Omnipred 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 Omnipred Drug Master File in Japan (Omnipred JDMF) empowers Omnipred 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 Omnipred JDMF during the approval evaluation for pharmaceutical products. At the time of Omnipred 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 Omnipred 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 Omnipred Drug Master File in Korea (Omnipred KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Omnipred. The MFDS reviews the Omnipred KDMF as part of the drug registration process and uses the information provided in the Omnipred KDMF to evaluate the safety and efficacy of the drug.
After submitting a Omnipred 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 Omnipred API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Omnipred suppliers with KDMF on PharmaCompass.
A Omnipred CEP of the European Pharmacopoeia monograph is often referred to as a Omnipred Certificate of Suitability (COS). The purpose of a Omnipred CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Omnipred EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Omnipred to their clients by showing that a Omnipred CEP has been issued for it. The manufacturer submits a Omnipred CEP (COS) as part of the market authorization procedure, and it takes on the role of a Omnipred CEP holder for the record. Additionally, the data presented in the Omnipred CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Omnipred DMF.
A Omnipred CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Omnipred 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 Omnipred suppliers with CEP (COS) on PharmaCompass.
A Omnipred written confirmation (Omnipred WC) is an official document issued by a regulatory agency to a Omnipred manufacturer, verifying that the manufacturing facility of a Omnipred active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Omnipred APIs or Omnipred finished pharmaceutical products to another nation, regulatory agencies frequently require a Omnipred WC (written confirmation) as part of the regulatory process.
click here to find a list of Omnipred 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 Omnipred as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Omnipred 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 Omnipred 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 Omnipred and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Omnipred NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Omnipred suppliers with NDC on PharmaCompass.
Omnipred 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 Omnipred 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 Omnipred GMP manufacturer or Omnipred GMP API supplier for your needs.
A Omnipred CoA (Certificate of Analysis) is a formal document that attests to Omnipred's compliance with Omnipred specifications and serves as a tool for batch-level quality control.
Omnipred CoA mostly includes findings from lab analyses of a specific batch. For each Omnipred 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.
Omnipred may be tested according to a variety of international standards, such as European Pharmacopoeia (Omnipred EP), Omnipred JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Omnipred USP).
