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Looking for 52-21-1 / Prednisolone Acetate API manufacturers, exporters & distributors?

Prednisolone Acetate manufacturers, exporters & distributors 1


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.

API | Excipient name

Prednisolone Acetate


52-21-1, Prednisolone 21-acetate, Omnipred, Econopred, Pricortin, Cormalone

Cas Number


Unique Ingredient Identifier (UNII)


About Prednisolone Acetate

Prednisolone Acetate is the acetate salt form of prednisolone, a synthetic glucocorticoid with anti-inflammatory and immunomodulating properties. As a glucocorticoid receptor agonist, prednisolone acetate binds to specific intracellular glucocorticoid receptors, and causes the ligand-receptor complex to be translocated to the nucleus where it initiates the transcription of glucocorticoid-responsive genes such as various cytokines and lipocortins. Lipocortins inhibit phospholipase A2, thereby blocking the release of arachidonic acid from membrane phospholipids and preventing the synthesis of prostaglandins and leukotrienes, both potent mediators of inflammation. This agent also decreases the number of circulating lymphocytes, induces cell differentiation, and stimulates apoptosis in sensitive tumor cell populations.

Prednisolone Acetate Manufacturers

A Prednisolone Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prednisolone Acetate, including repackagers and relabelers. The FDA regulates Prednisolone Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prednisolone Acetate 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 Prednisolone Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Prednisolone Acetate Suppliers

A Prednisolone Acetate supplier is an individual or a company that provides Prednisolone Acetate active pharmaceutical ingredient (API) or Prednisolone Acetate finished formulations upon request. The Prednisolone Acetate suppliers may include Prednisolone Acetate API manufacturers, exporters, distributors and traders.

click here to find a list of Prednisolone Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Prednisolone Acetate USDMF

A Prednisolone Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Prednisolone Acetate active pharmaceutical ingredient (API) in detail. Different forms of Prednisolone Acetate DMFs exist exist since differing nations have different regulations, such as Prednisolone Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Prednisolone Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Prednisolone Acetate USDMF includes data on Prednisolone Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prednisolone Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Prednisolone Acetate suppliers with USDMF on PharmaCompass.

Prednisolone Acetate JDMF

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 Prednisolone Acetate Drug Master File in Japan (Prednisolone Acetate JDMF) empowers Prednisolone Acetate 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 Prednisolone Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Prednisolone Acetate 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 Prednisolone Acetate suppliers with JDMF on PharmaCompass.

Prednisolone Acetate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Prednisolone Acetate Drug Master File in Korea (Prednisolone Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prednisolone Acetate. The MFDS reviews the Prednisolone Acetate KDMF as part of the drug registration process and uses the information provided in the Prednisolone Acetate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Prednisolone Acetate 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 Prednisolone Acetate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Prednisolone Acetate suppliers with KDMF on PharmaCompass.

Prednisolone Acetate CEP

A Prednisolone Acetate CEP of the European Pharmacopoeia monograph is often referred to as a Prednisolone Acetate Certificate of Suitability (COS). The purpose of a Prednisolone Acetate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prednisolone Acetate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prednisolone Acetate to their clients by showing that a Prednisolone Acetate CEP has been issued for it. The manufacturer submits a Prednisolone Acetate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prednisolone Acetate CEP holder for the record. Additionally, the data presented in the Prednisolone Acetate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prednisolone Acetate DMF.

A Prednisolone Acetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prednisolone Acetate 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 Prednisolone Acetate suppliers with CEP (COS) on PharmaCompass.

Prednisolone Acetate WC

A Prednisolone Acetate written confirmation (Prednisolone Acetate WC) is an official document issued by a regulatory agency to a Prednisolone Acetate manufacturer, verifying that the manufacturing facility of a Prednisolone Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prednisolone Acetate APIs or Prednisolone Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Prednisolone Acetate WC (written confirmation) as part of the regulatory process.

click here to find a list of Prednisolone Acetate suppliers with Written Confirmation (WC) on PharmaCompass.

Prednisolone Acetate NDC

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 Prednisolone Acetate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Prednisolone Acetate API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Prednisolone Acetate 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Prednisolone Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prednisolone Acetate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Prednisolone Acetate suppliers with NDC on PharmaCompass.

Prednisolone Acetate GMP

Prednisolone Acetate 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 Prednisolone Acetate 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 Prednisolone Acetate GMP manufacturer or Prednisolone Acetate GMP API supplier for your needs.

Prednisolone Acetate CoA

A Prednisolone Acetate CoA (Certificate of Analysis) is a formal document that attests to Prednisolone Acetate's compliance with Prednisolone Acetate specifications and serves as a tool for batch-level quality control.

Prednisolone Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Prednisolone Acetate 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.

Prednisolone Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Prednisolone Acetate EP), Prednisolone Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prednisolone Acetate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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