Synopsis
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
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.
...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...
Axplora is your partner of choice for complex APIs.
Hydrocortisone Hemisuccinate Hydrate
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
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 located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
Hydrocortisone Sodium Phosphate
About the Company : Bioquim is a European company specializing in bulk oral & sterile APIs for the pharmaceutical industry. With over 40 years of experience, we offer high-quality corticosteroids, pep...
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API Imports and Exports
Drugs in Development
Lead Product(s) : Opevesostat,Dexamethasone,Hydrocortisone
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
Phase 3 Clinical Trials with ODM-208 (MK-5684) posted to ClinicalTrials.gov Database
Details : ODM-208 (or MK-5684) is an investigational oral, non-steroidal and selective inhibitor of the CYP11A1 enzyme discovered and developed by Orion for the treatment of hormone-dependent cancers, such as metastatic castration-resistant prostate cancer.
Product Name : ODM-208
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 21, 2023
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Flebocortid Richter
Dosage Form : Hydrocortisone 1G 1 Units Parenteral Use
Dosage Strength : 1 bottle EV 1 g + 1 ampoule solv 10 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Proctosedyl
Dosage Form : Rectal Salve
Dosage Strength : (not entered)
Packaging : Tube
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Sweden
Brand Name : Hydrokortison Orion
Dosage Form : TABLETT
Dosage Strength : 10 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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DOSAGE - SUSPENSION/DROPS;OTIC - EQ 0.2% BASE...DOSAGE - SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%
USFDA APPLICATION NUMBER - 20805
DOSAGE - CREAM;TOPICAL - 5%;1%
USFDA APPLICATION NUMBER - 22436
DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;E...DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50168
DOSAGE - CREAM;TOPICAL - 1%
USFDA APPLICATION NUMBER - 80693
DOSAGE - LOTION;TOPICAL - 2%
USFDA APPLICATION NUMBER - 83231
DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 8697
DOSAGE - TABLET;ORAL - 20MG
USFDA APPLICATION NUMBER - 8697
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 8697
Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lubrizol Life Science Health
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shandong Focus Biotechnology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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Fillers, Diluents & Binders
Thickeners and Stabilizers
Solubilizers
Parenteral
Direct Compression
Coating Systems & Additives
Lubricants & Glidants
Granulation
Emulsifying Agents
Disintegrants & Superdisintegrants
Controlled & Modified Release
Film Formers & Plasticizers
Surfactant & Foaming Agents
Taste Masking
Co-Processed Excipients
Chewable & Orodispersible Aids
Rheology Modifiers
API Stability Enhancers
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Cream / Lotion / Ointment, Suspension
Grade : Topical
Application : API Stability Enhancers, Thickeners and Stabilizers
Excipient Details : Xanthan gum, a polysaccharide widely used in many industries as a food additive, thickening agent and stabilizer in topical formulations.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Dosage Form : Cream / Lotion / Ointment, Capsule, Gel, Tablet
Grade : Oral, Topical
Application : API Stability Enhancers, Thickeners and Stabilizers
Excipient Details : Xanthan gum is widely used in oral dosage forms as a suspending and thickening agent. It is also used in topical formulations as a stabilizer.
Coloring Agents
Soft Gelatin
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REF. STANDARDS & IMPURITIES
ANALYTICAL
BioAnalytical Methods
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ABOUT THIS PAGE
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PharmaCompass offers a list of Hydrocortisone 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 Hydrocortisone manufacturer or Hydrocortisone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydrocortisone manufacturer or Hydrocortisone supplier.
PharmaCompass also assists you with knowing the Hydrocortisone API Price utilized in the formulation of products. Hydrocortisone API Price is not always fixed or binding as the Hydrocortisone Price is obtained through a variety of data sources. The Hydrocortisone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lactisona manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lactisona, including repackagers and relabelers. The FDA regulates Lactisona manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lactisona 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 Lactisona manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lactisona supplier is an individual or a company that provides Lactisona active pharmaceutical ingredient (API) or Lactisona finished formulations upon request. The Lactisona suppliers may include Lactisona API manufacturers, exporters, distributors and traders.
click here to find a list of Lactisona suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lactisona DMF (Drug Master File) is a document detailing the whole manufacturing process of Lactisona active pharmaceutical ingredient (API) in detail. Different forms of Lactisona DMFs exist exist since differing nations have different regulations, such as Lactisona USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lactisona DMF submitted to regulatory agencies in the US is known as a USDMF. Lactisona USDMF includes data on Lactisona's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lactisona USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lactisona 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 Lactisona Drug Master File in Japan (Lactisona JDMF) empowers Lactisona 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 Lactisona JDMF during the approval evaluation for pharmaceutical products. At the time of Lactisona 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 Lactisona 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 Lactisona Drug Master File in Korea (Lactisona KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lactisona. The MFDS reviews the Lactisona KDMF as part of the drug registration process and uses the information provided in the Lactisona KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lactisona 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 Lactisona API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lactisona suppliers with KDMF on PharmaCompass.
A Lactisona CEP of the European Pharmacopoeia monograph is often referred to as a Lactisona Certificate of Suitability (COS). The purpose of a Lactisona CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lactisona EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lactisona to their clients by showing that a Lactisona CEP has been issued for it. The manufacturer submits a Lactisona CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lactisona CEP holder for the record. Additionally, the data presented in the Lactisona CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lactisona DMF.
A Lactisona CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lactisona 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 Lactisona suppliers with CEP (COS) on PharmaCompass.
A Lactisona written confirmation (Lactisona WC) is an official document issued by a regulatory agency to a Lactisona manufacturer, verifying that the manufacturing facility of a Lactisona active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lactisona APIs or Lactisona finished pharmaceutical products to another nation, regulatory agencies frequently require a Lactisona WC (written confirmation) as part of the regulatory process.
click here to find a list of Lactisona 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 Lactisona as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lactisona 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 Lactisona 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 Lactisona and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lactisona NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lactisona suppliers with NDC on PharmaCompass.
Lactisona 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 Lactisona 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 Lactisona GMP manufacturer or Lactisona GMP API supplier for your needs.
A Lactisona CoA (Certificate of Analysis) is a formal document that attests to Lactisona's compliance with Lactisona specifications and serves as a tool for batch-level quality control.
Lactisona CoA mostly includes findings from lab analyses of a specific batch. For each Lactisona 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.
Lactisona may be tested according to a variety of international standards, such as European Pharmacopoeia (Lactisona EP), Lactisona JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lactisona USP).
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