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API SUPPLIERS
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USDMF
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Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
Hydrocortisone Hydrogen Succinate
Certificate Number : R1-CEP 2015-183 - Rev 00
Status : Valid
Issue Date : 2021-10-07
Type : Chemical
Substance Number : 768
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Hydrocortisone Hydrogen Succinate
Certificate Number : R0-CEP 2020-246 - Rev 01
Status : Valid
Issue Date : 2021-12-16
Type : Chemical
Substance Number : 768
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Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Hydrocortisone Sodium Succinate USP
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0161
Address of the Firm : 385/2, Gram Pigdamber, Rau , Indore-453331, Madhya Pradesh, India
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Hydrocortisone Sodium Succinate USP
Date of Issue : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161n
Address of the Firm : PLOT NO.385/2, Gram Pigdamber, Rau , Indore-453331, Madhya Pradesh, India
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Hydrocortisone Sodium Succinate USP
Date of Issue : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161n
Address of the Firm : PLOT NO.385/2, Gram Pigdamber, Rau , Indore-453331, Madhya Pradesh, India
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Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
Hydrocortisone Sodium Succinate
About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expe...
Cerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.
Hydrocortisone Sodium Succinate
About the Company : Cerata Pharmaceuticals LLP is a WHO-GMP certified pharmaceutical API manufacturer based in Gujarat, India. We specialize in the development and manufacturing of high-quality APIs a...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Hydrocortisone Sodium Succinate
About the Company : Symbiotec, based in Indore, India, is a leading API manufacturer specializing in cortico-steroids and steroid-hormone APIs since 1995. Focused on R&D, sustainability, and innovatio...
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
Hydrocortisone Sodium Succinate
About the Company : Pfizer CentreOne® is an altogether different global contract development and manufacturing organization (CDMO), and a leading supplier of specialty APIs and intermediates.
...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Hydrocortisone Sodium Succinate
About the Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio o...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
Hydrocortisone Sodium Succinate
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Hydrocortisone Sodium Succinate
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
Hydrocortisone Sodium Succinate
About the Company : Bioquim is a European company specializing in bulk oral and sterile APIs for the pharmaceutical industry. With over 40 years of experience, the company supplies corticosteroids, pe...
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DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE/VIAL
USFDA APPLICATION NUMBER - 9866
DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/VIAL
USFDA APPLICATION NUMBER - 9866
DOSAGE - INJECTABLE;INJECTION - EQ 250MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 250MG BASE/VIAL
USFDA APPLICATION NUMBER - 9866
DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE/VIAL
USFDA APPLICATION NUMBER - 9866
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PharmaCompass offers a list of Hydrocortisone Sodium Succinate 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 Hydrocortisone Sodium Succinate manufacturer or Hydrocortisone Sodium Succinate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydrocortisone Sodium Succinate manufacturer or Hydrocortisone Sodium Succinate supplier.
A Hidrokortizon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hidrokortizon, including repackagers and relabelers. The FDA regulates Hidrokortizon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hidrokortizon 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 Hidrokortizon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Hidrokortizon supplier is an individual or a company that provides Hidrokortizon active pharmaceutical ingredient (API) or Hidrokortizon finished formulations upon request. The Hidrokortizon suppliers may include Hidrokortizon API manufacturers, exporters, distributors and traders.
click here to find a list of Hidrokortizon suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Hidrokortizon DMF (Drug Master File) is a document detailing the whole manufacturing process of Hidrokortizon active pharmaceutical ingredient (API) in detail. Different forms of Hidrokortizon DMFs exist exist since differing nations have different regulations, such as Hidrokortizon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hidrokortizon DMF submitted to regulatory agencies in the US is known as a USDMF. Hidrokortizon USDMF includes data on Hidrokortizon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hidrokortizon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hidrokortizon suppliers with USDMF 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 Hidrokortizon Drug Master File in Korea (Hidrokortizon KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hidrokortizon. The MFDS reviews the Hidrokortizon KDMF as part of the drug registration process and uses the information provided in the Hidrokortizon KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hidrokortizon 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 Hidrokortizon API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hidrokortizon suppliers with KDMF on PharmaCompass.
A Hidrokortizon CEP of the European Pharmacopoeia monograph is often referred to as a Hidrokortizon Certificate of Suitability (COS). The purpose of a Hidrokortizon CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hidrokortizon EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hidrokortizon to their clients by showing that a Hidrokortizon CEP has been issued for it. The manufacturer submits a Hidrokortizon CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hidrokortizon CEP holder for the record. Additionally, the data presented in the Hidrokortizon CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hidrokortizon DMF.
A Hidrokortizon CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hidrokortizon 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 Hidrokortizon suppliers with CEP (COS) on PharmaCompass.
A Hidrokortizon written confirmation (Hidrokortizon WC) is an official document issued by a regulatory agency to a Hidrokortizon manufacturer, verifying that the manufacturing facility of a Hidrokortizon active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hidrokortizon APIs or Hidrokortizon finished pharmaceutical products to another nation, regulatory agencies frequently require a Hidrokortizon WC (written confirmation) as part of the regulatory process.
click here to find a list of Hidrokortizon 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 Hidrokortizon as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hidrokortizon 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 Hidrokortizon 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 Hidrokortizon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hidrokortizon NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hidrokortizon suppliers with NDC on PharmaCompass.
Hidrokortizon 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 Hidrokortizon GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Hidrokortizon GMP manufacturer or Hidrokortizon GMP API supplier for your needs.
A Hidrokortizon CoA (Certificate of Analysis) is a formal document that attests to Hidrokortizon's compliance with Hidrokortizon specifications and serves as a tool for batch-level quality control.
Hidrokortizon CoA mostly includes findings from lab analyses of a specific batch. For each Hidrokortizon 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.
Hidrokortizon may be tested according to a variety of international standards, such as European Pharmacopoeia (Hidrokortizon EP), Hidrokortizon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hidrokortizon USP).
