Synopsis
0
CEP/COS
0
JDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
FDF
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39561
Submission : 2024-06-19
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
About the Company : Polpharma API, a division of a leading Polish pharmaceutical group, has over 75 years of expertise in process development and cGMP manufacturing. Based at an FDA-approved site in C...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - EQ 0.5MG
USFDA APPLICATION NUMBER - 204114
DOSAGE - TABLET;ORAL - EQ 1MG **Federal Regis...DOSAGE - TABLET;ORAL - EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 204114
DOSAGE - TABLET;ORAL - EQ 2MG
USFDA APPLICATION NUMBER - 204114
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gloria Interchem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Neelkanth MineChem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
Fillers, Diluents & Binders
Direct Compression
Controlled & Modified Release
Thickeners and Stabilizers
Disintegrants & Superdisintegrants
Granulation
Solubilizers
Chewable & Orodispersible Aids
Taste Masking
Lubricants & Glidants
Topical
Co-Processed Excipients
Parenteral
Film Formers & Plasticizers
Emulsifying Agents
Empty Capsules
API Stability Enhancers
Vegetarian Capsules
Surfactant & Foaming Agents
Rheology Modifiers
Coloring Agents
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
ABOUT THIS PAGE
86
PharmaCompass offers a list of Trametinib 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 Trametinib manufacturer or Trametinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Trametinib manufacturer or Trametinib supplier.
A Trametinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trametinib, including repackagers and relabelers. The FDA regulates Trametinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trametinib 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 Trametinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Trametinib supplier is an individual or a company that provides Trametinib active pharmaceutical ingredient (API) or Trametinib finished formulations upon request. The Trametinib suppliers may include Trametinib API manufacturers, exporters, distributors and traders.
click here to find a list of Trametinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Trametinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Trametinib active pharmaceutical ingredient (API) in detail. Different forms of Trametinib DMFs exist exist since differing nations have different regulations, such as Trametinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trametinib DMF submitted to regulatory agencies in the US is known as a USDMF. Trametinib USDMF includes data on Trametinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trametinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trametinib 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 Trametinib Drug Master File in Korea (Trametinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Trametinib. The MFDS reviews the Trametinib KDMF as part of the drug registration process and uses the information provided in the Trametinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Trametinib 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 Trametinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Trametinib suppliers with KDMF on PharmaCompass.
A Trametinib written confirmation (Trametinib WC) is an official document issued by a regulatory agency to a Trametinib manufacturer, verifying that the manufacturing facility of a Trametinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trametinib APIs or Trametinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Trametinib WC (written confirmation) as part of the regulatory process.
click here to find a list of Trametinib 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 Trametinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trametinib 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 Trametinib 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 Trametinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trametinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trametinib suppliers with NDC on PharmaCompass.
Trametinib 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 Trametinib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Trametinib GMP manufacturer or Trametinib GMP API supplier for your needs.
A Trametinib CoA (Certificate of Analysis) is a formal document that attests to Trametinib's compliance with Trametinib specifications and serves as a tool for batch-level quality control.
Trametinib CoA mostly includes findings from lab analyses of a specific batch. For each Trametinib 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.
Trametinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Trametinib EP), Trametinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trametinib USP).
