Synopsis
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EU WC
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Chirogate is a professional Prostaglandin manufacturer.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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USDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10948
Submission : 1994-06-20
Status :
Type : II
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : R1-CEP 2015-302 - Rev 00
Status : Valid
Issue Date : 2022-01-31
Type : Chemical
Substance Number : 1488
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DOSAGE - INJECTABLE;INJECTION - 0.005MG/VIAL
USFDA APPLICATION NUMBER - 20379
DOSAGE - INJECTABLE;INJECTION - 0.01MG/VIAL
USFDA APPLICATION NUMBER - 20379
DOSAGE - INJECTABLE;INJECTION - 0.02MG/VIAL
USFDA APPLICATION NUMBER - 20379
DOSAGE - INJECTABLE;INJECTION - 0.04MG/VIAL
USFDA APPLICATION NUMBER - 20379
Related Excipient Companies
Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
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Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet
Grade : Parenteral, Oral, Topical
Application : Parenteral, Solubilizers, Topical
Excipient Details : Benzyl alcohol is used as a bacteriostatic & preservative in parenteral & ophthalmic products. It is widely used in oral & topical formulations.
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
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : Sodium Chloride 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 : Trisodium Citrate
Application : Parenteral
Excipient Details : Used as a buffering agent in purification process during downstream and in the final formulation.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : Trisodium Citrate Excipient
Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet
Grade : Parenteral, Oral, Topical
Application : Parenteral, Solubilizers, Topical
Excipient Details : Benzyl alcohol is used as a bacteriostatic & preservative in parenteral & ophthalmic products. It is widely used in oral & topical formulations.
Dr. Paul Lohmann® provides premium mineral salts backed by 140+ years of innovation, quality manufacturing, and global expertise.
Dosage Form : Cream / Lotion / Ointment, Solution
Grade : Oral
Brand Name : Trisodium Citrate Anhydrous
Application : API Stability Enhancers, Topical
Excipient Details : Trisodium Citrate, anhydrous is used as an emollient in various semi-solid topical formulations. It is also used as a pH-modifier in oral liquids.
Solubilizers
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet
Grade : Parenteral, Oral, Topical
Application : Parenteral, Solubilizers, Topical
Excipient Details : Benzyl alcohol is used as a bacteriostatic & preservative in parenteral & ophthalmic products. It is widely used in oral & topical formulations.
Granulation
Direct Compression
Chewable & Orodispersible Aids
API Stability Enhancers
Thickeners and Stabilizers
Controlled & Modified Release
Co-Processed Excipients
Fillers, Diluents & Binders
Coating Systems & Additives
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
EDQM
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
29
PharmaCompass offers a list of Alprostadil 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 Alprostadil manufacturer or Alprostadil supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alprostadil manufacturer or Alprostadil supplier.
A FemLife manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of FemLife, including repackagers and relabelers. The FDA regulates FemLife manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. FemLife 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 FemLife manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A FemLife supplier is an individual or a company that provides FemLife active pharmaceutical ingredient (API) or FemLife finished formulations upon request. The FemLife suppliers may include FemLife API manufacturers, exporters, distributors and traders.
click here to find a list of FemLife suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A FemLife DMF (Drug Master File) is a document detailing the whole manufacturing process of FemLife active pharmaceutical ingredient (API) in detail. Different forms of FemLife DMFs exist exist since differing nations have different regulations, such as FemLife USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A FemLife DMF submitted to regulatory agencies in the US is known as a USDMF. FemLife USDMF includes data on FemLife's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The FemLife USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of FemLife 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 FemLife Drug Master File in Japan (FemLife JDMF) empowers FemLife 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 FemLife JDMF during the approval evaluation for pharmaceutical products. At the time of FemLife 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 FemLife 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 FemLife Drug Master File in Korea (FemLife KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of FemLife. The MFDS reviews the FemLife KDMF as part of the drug registration process and uses the information provided in the FemLife KDMF to evaluate the safety and efficacy of the drug.
After submitting a FemLife 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 FemLife API can apply through the Korea Drug Master File (KDMF).
click here to find a list of FemLife suppliers with KDMF on PharmaCompass.
A FemLife CEP of the European Pharmacopoeia monograph is often referred to as a FemLife Certificate of Suitability (COS). The purpose of a FemLife CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of FemLife EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of FemLife to their clients by showing that a FemLife CEP has been issued for it. The manufacturer submits a FemLife CEP (COS) as part of the market authorization procedure, and it takes on the role of a FemLife CEP holder for the record. Additionally, the data presented in the FemLife CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the FemLife DMF.
A FemLife CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. FemLife 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 FemLife suppliers with CEP (COS) 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 FemLife as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for FemLife 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 FemLife 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 FemLife and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a FemLife NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of FemLife suppliers with NDC on PharmaCompass.
FemLife 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 FemLife GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right FemLife GMP manufacturer or FemLife GMP API supplier for your needs.
A FemLife CoA (Certificate of Analysis) is a formal document that attests to FemLife's compliance with FemLife specifications and serves as a tool for batch-level quality control.
FemLife CoA mostly includes findings from lab analyses of a specific batch. For each FemLife 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.
FemLife may be tested according to a variety of international standards, such as European Pharmacopoeia (FemLife EP), FemLife JP (Japanese Pharmacopeia) and the US Pharmacopoeia (FemLife USP).
