Synopsis
0
EU WC
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
NDC
KDMF
ASMF 
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]CEP/COS
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Certificate Number : R0-CEP 2019-180 - Rev 00
Status : Valid
Issue Date : 2021-09-28
Type : Chemical
Substance Number : 2101
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Tetrahydrozoline hydrochloride
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2024-03-11
Registration Number : 20240311-211-J-1616
Manufacturer Name : PCAS Finland Oy
Manufacturer Address : Messukentankatu 8, 20210 Turku, Finland
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
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
Upgrade, download data, analyse, strategize, subscribe with us 
INTERMEDIATES 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]Related Excipient Companies
SPI Pharma
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]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]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]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]Nanjing Bold Chemical
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]Solubilizers
Parenteral
Topical
Emulsifying Agents
Fillers, Diluents & Binders
Surfactant & Foaming Agents
API Stability Enhancers
Thickeners and Stabilizers
Film Formers & Plasticizers
Co-Processed Excipients
Direct Compression
Rheology Modifiers
Taste Masking
Controlled & Modified Release
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Tetrahydrozoline Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tetrahydrozoline Hydrochloride, including repackagers and relabelers. The FDA regulates Tetrahydrozoline Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tetrahydrozoline Hydrochloride 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 Tetrahydrozoline Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tetrahydrozoline Hydrochloride supplier is an individual or a company that provides Tetrahydrozoline Hydrochloride active pharmaceutical ingredient (API) or Tetrahydrozoline Hydrochloride finished formulations upon request. The Tetrahydrozoline Hydrochloride suppliers may include Tetrahydrozoline Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Tetrahydrozoline Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tetrahydrozoline Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Tetrahydrozoline Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Tetrahydrozoline Hydrochloride DMFs exist exist since differing nations have different regulations, such as Tetrahydrozoline Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tetrahydrozoline Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Tetrahydrozoline Hydrochloride USDMF includes data on Tetrahydrozoline Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tetrahydrozoline Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tetrahydrozoline Hydrochloride 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 Tetrahydrozoline Hydrochloride Drug Master File in Japan (Tetrahydrozoline Hydrochloride JDMF) empowers Tetrahydrozoline Hydrochloride 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 Tetrahydrozoline Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Tetrahydrozoline Hydrochloride 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 Tetrahydrozoline Hydrochloride 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 Tetrahydrozoline Hydrochloride Drug Master File in Korea (Tetrahydrozoline Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tetrahydrozoline Hydrochloride. The MFDS reviews the Tetrahydrozoline Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Tetrahydrozoline Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tetrahydrozoline Hydrochloride 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 Tetrahydrozoline Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tetrahydrozoline Hydrochloride suppliers with KDMF on PharmaCompass.
A Tetrahydrozoline Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Tetrahydrozoline Hydrochloride Certificate of Suitability (COS). The purpose of a Tetrahydrozoline Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tetrahydrozoline Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tetrahydrozoline Hydrochloride to their clients by showing that a Tetrahydrozoline Hydrochloride CEP has been issued for it. The manufacturer submits a Tetrahydrozoline Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tetrahydrozoline Hydrochloride CEP holder for the record. Additionally, the data presented in the Tetrahydrozoline Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tetrahydrozoline Hydrochloride DMF.
A Tetrahydrozoline Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tetrahydrozoline Hydrochloride 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 Tetrahydrozoline Hydrochloride 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 Tetrahydrozoline Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tetrahydrozoline Hydrochloride 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 Tetrahydrozoline Hydrochloride 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 Tetrahydrozoline Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tetrahydrozoline Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tetrahydrozoline Hydrochloride suppliers with NDC on PharmaCompass.
Tetrahydrozoline Hydrochloride 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 Tetrahydrozoline Hydrochloride 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 Tetrahydrozoline Hydrochloride GMP manufacturer or Tetrahydrozoline Hydrochloride GMP API supplier for your needs.
A Tetrahydrozoline Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Tetrahydrozoline Hydrochloride's compliance with Tetrahydrozoline Hydrochloride specifications and serves as a tool for batch-level quality control.
Tetrahydrozoline Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Tetrahydrozoline Hydrochloride 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.
Tetrahydrozoline Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Tetrahydrozoline Hydrochloride EP), Tetrahydrozoline Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tetrahydrozoline Hydrochloride USP).
LOOKING FOR A SUPPLIER?
