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API SUPPLIERS
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USDMF
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DOSAGE - INJECTABLE;INJECTION - 20MG/ML
USFDA APPLICATION NUMBER - 11757
DOSAGE - INJECTABLE;INJECTION - 40MG/ML
USFDA APPLICATION NUMBER - 11757
DOSAGE - INJECTABLE;INJECTION - 80MG/ML
USFDA APPLICATION NUMBER - 11757
Related Excipient Companies
Nanjing Well Pharmaceutical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Gel
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Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Capsule
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Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Parenteral
Excipient Details : Used as an osmolarity agent in culture media, tonicity adjuster in ophthalmics and parenterals solutions.
Pharmacopoeia Ref : On Request
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Excipient Details : Used as a buffering agent in cell culture, purification processes and injectable formulations.
Pharmacopoeia Ref : On Request
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Ingredient(s) : Sodium Dihydrogen Phosphate Monohydrate Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Brand Name : Sodium Phosphate, Dibasic...
Application : Parenteral
Excipient Details : Used as a buffering agent in cell culture, purification processes and injectable formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Sodium Phosphate, Dibasic, Anhydrous Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
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Brand Name : Sodium Phosphate, Monobas...
Application : Parenteral
Excipient Details : Used as a buffering agent in cell culture, purification processes and injectable formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Sodium Dihydrogen Phosphate Monohydrate Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Surfactant & Foaming Agents
Excipient Details : Used as surfactant agent in cell culture media, in protein purification and in injectable formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Polysorbate 80
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FDF DOSSIERS
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Methylprednisolone 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 Methylprednisolone Acetate manufacturer or Methylprednisolone Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methylprednisolone Acetate manufacturer or Methylprednisolone Acetate supplier.
PharmaCompass also assists you with knowing the Methylprednisolone Acetate API Price utilized in the formulation of products. Methylprednisolone Acetate API Price is not always fixed or binding as the Methylprednisolone Acetate Price is obtained through a variety of data sources. The Methylprednisolone Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Unidrol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Unidrol, including repackagers and relabelers. The FDA regulates Unidrol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Unidrol 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 Unidrol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Unidrol supplier is an individual or a company that provides Unidrol active pharmaceutical ingredient (API) or Unidrol finished formulations upon request. The Unidrol suppliers may include Unidrol API manufacturers, exporters, distributors and traders.
click here to find a list of Unidrol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Unidrol DMF (Drug Master File) is a document detailing the whole manufacturing process of Unidrol active pharmaceutical ingredient (API) in detail. Different forms of Unidrol DMFs exist exist since differing nations have different regulations, such as Unidrol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Unidrol DMF submitted to regulatory agencies in the US is known as a USDMF. Unidrol USDMF includes data on Unidrol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Unidrol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Unidrol suppliers with USDMF on PharmaCompass.
A Unidrol CEP of the European Pharmacopoeia monograph is often referred to as a Unidrol Certificate of Suitability (COS). The purpose of a Unidrol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Unidrol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Unidrol to their clients by showing that a Unidrol CEP has been issued for it. The manufacturer submits a Unidrol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Unidrol CEP holder for the record. Additionally, the data presented in the Unidrol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Unidrol DMF.
A Unidrol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Unidrol 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 Unidrol suppliers with CEP (COS) on PharmaCompass.
A Unidrol written confirmation (Unidrol WC) is an official document issued by a regulatory agency to a Unidrol manufacturer, verifying that the manufacturing facility of a Unidrol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Unidrol APIs or Unidrol finished pharmaceutical products to another nation, regulatory agencies frequently require a Unidrol WC (written confirmation) as part of the regulatory process.
click here to find a list of Unidrol 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 Unidrol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Unidrol 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 Unidrol 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 Unidrol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Unidrol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Unidrol suppliers with NDC on PharmaCompass.
Unidrol 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 Unidrol 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 Unidrol GMP manufacturer or Unidrol GMP API supplier for your needs.
A Unidrol CoA (Certificate of Analysis) is a formal document that attests to Unidrol's compliance with Unidrol specifications and serves as a tool for batch-level quality control.
Unidrol CoA mostly includes findings from lab analyses of a specific batch. For each Unidrol 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.
Unidrol may be tested according to a variety of international standards, such as European Pharmacopoeia (Unidrol EP), Unidrol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Unidrol USP).
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