Synopsis
0
CEP/COS
0
JDMF
0
VMF
0
FDF
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
EDQM
0
USP
0
JP
0
Others
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
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]INTERMEDIATES SUPPLIERS
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
(R)-(-)-2-Amino-3-methyl-1-butanol
CAS Number : 4276-09-9
End Use API : Elvitegravir
About The Company : USV is a leading health care company with focus on Active Pharmaceutical Ingredients (marketed globally with emphasis on regulated markets of USA, European Unio...
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]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 150MG
USFDA APPLICATION NUMBER - 203093
DOSAGE - TABLET;ORAL - 85MG
USFDA APPLICATION NUMBER - 203093
DOSAGE - TABLET;ORAL - 150MG;150MG;200MG;300M...DOSAGE - TABLET;ORAL - 150MG;150MG;200MG;300MG
USFDA APPLICATION NUMBER - 203100
DOSAGE - TABLET;ORAL - 150MG;150MG;200MG;EQ 1...DOSAGE - TABLET;ORAL - 150MG;150MG;200MG;EQ 10MG BASE
USFDA APPLICATION NUMBER - 207561
Related Excipient Companies
SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seqens
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
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]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
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]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]Ideal Cures Pvt Ltd
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]Microlex e.U
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]Roquette
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]Fillers, Diluents & Binders
Coating Systems & Additives
Direct Compression
Lubricants & Glidants
Disintegrants & Superdisintegrants
Thickeners and Stabilizers
Granulation
Controlled & Modified Release
Co-Processed Excipients
Topical
Parenteral
Film Formers & Plasticizers
Taste Masking
Solubilizers
Emulsifying Agents
API Stability Enhancers
Coloring Agents
Rheology Modifiers
Chewable & Orodispersible Aids
Surfactant & Foaming Agents
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
Market Place
ABOUT THIS PAGE
A Jtk 303 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Jtk 303, including repackagers and relabelers. The FDA regulates Jtk 303 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Jtk 303 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 Jtk 303 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Jtk 303 supplier is an individual or a company that provides Jtk 303 active pharmaceutical ingredient (API) or Jtk 303 finished formulations upon request. The Jtk 303 suppliers may include Jtk 303 API manufacturers, exporters, distributors and traders.
click here to find a list of Jtk 303 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Jtk 303 DMF (Drug Master File) is a document detailing the whole manufacturing process of Jtk 303 active pharmaceutical ingredient (API) in detail. Different forms of Jtk 303 DMFs exist exist since differing nations have different regulations, such as Jtk 303 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Jtk 303 DMF submitted to regulatory agencies in the US is known as a USDMF. Jtk 303 USDMF includes data on Jtk 303's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Jtk 303 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Jtk 303 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 Jtk 303 Drug Master File in Korea (Jtk 303 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Jtk 303. The MFDS reviews the Jtk 303 KDMF as part of the drug registration process and uses the information provided in the Jtk 303 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Jtk 303 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 Jtk 303 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Jtk 303 suppliers with KDMF on PharmaCompass.
A Jtk 303 written confirmation (Jtk 303 WC) is an official document issued by a regulatory agency to a Jtk 303 manufacturer, verifying that the manufacturing facility of a Jtk 303 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Jtk 303 APIs or Jtk 303 finished pharmaceutical products to another nation, regulatory agencies frequently require a Jtk 303 WC (written confirmation) as part of the regulatory process.
click here to find a list of Jtk 303 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 Jtk 303 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Jtk 303 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 Jtk 303 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 Jtk 303 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Jtk 303 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Jtk 303 suppliers with NDC on PharmaCompass.
Jtk 303 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 Jtk 303 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 Jtk 303 GMP manufacturer or Jtk 303 GMP API supplier for your needs.
A Jtk 303 CoA (Certificate of Analysis) is a formal document that attests to Jtk 303's compliance with Jtk 303 specifications and serves as a tool for batch-level quality control.
Jtk 303 CoA mostly includes findings from lab analyses of a specific batch. For each Jtk 303 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.
Jtk 303 may be tested according to a variety of international standards, such as European Pharmacopoeia (Jtk 303 EP), Jtk 303 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Jtk 303 USP).
LOOKING FOR A SUPPLIER?
