Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
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]CEP/COS
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]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]Australia
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 100MG BASE
USFDA APPLICATION NUMBER - 19839
DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19839
DOSAGE - TABLET;ORAL - EQ 200MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19839
DOSAGE - TABLET;ORAL - EQ 25MG BASE
USFDA APPLICATION NUMBER - 19839
DOSAGE - TABLET;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 19839
Related Excipient Companies
EUROAPI
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]Boai NKY Pharmaceuticals Ltd
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]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Cerata Pharmaceuticals LLP
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]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
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]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
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]Huzhou Sunflower Pharmaceutical
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]JJ 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]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]Shanghai Welltone Material Technology Co., Ltd
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]Symrise
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]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Coating Systems & Additives
Solubilizers
Direct Compression
Disintegrants & Superdisintegrants
Controlled & Modified Release
Granulation
Thickeners and Stabilizers
Topical
Film Formers & Plasticizers
Parenteral
Lubricants & Glidants
Co-Processed Excipients
API Stability Enhancers
Taste Masking
Emulsifying Agents
Chewable & Orodispersible Aids
Empty Capsules
Rheology Modifiers
Vegetarian Capsules
Surfactant & Foaming Agents
Coloring Agents
Digital Content
DATA COMPILATION #PharmaFlow
STOCK RECAP #PipelineProspector
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
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
23
PharmaCompass offers a list of Sertraline Hydrochloride 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 Sertraline Hydrochloride manufacturer or Sertraline Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sertraline Hydrochloride manufacturer or Sertraline Hydrochloride supplier.
PharmaCompass also assists you with knowing the Sertraline Hydrochloride API Price utilized in the formulation of products. Sertraline Hydrochloride API Price is not always fixed or binding as the Sertraline Hydrochloride Price is obtained through a variety of data sources. The Sertraline Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Altruline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Altruline, including repackagers and relabelers. The FDA regulates Altruline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Altruline 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 Altruline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Altruline supplier is an individual or a company that provides Altruline active pharmaceutical ingredient (API) or Altruline finished formulations upon request. The Altruline suppliers may include Altruline API manufacturers, exporters, distributors and traders.
click here to find a list of Altruline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Altruline DMF (Drug Master File) is a document detailing the whole manufacturing process of Altruline active pharmaceutical ingredient (API) in detail. Different forms of Altruline DMFs exist exist since differing nations have different regulations, such as Altruline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Altruline DMF submitted to regulatory agencies in the US is known as a USDMF. Altruline USDMF includes data on Altruline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Altruline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Altruline 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 Altruline Drug Master File in Japan (Altruline JDMF) empowers Altruline 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 Altruline JDMF during the approval evaluation for pharmaceutical products. At the time of Altruline 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 Altruline 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 Altruline Drug Master File in Korea (Altruline KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Altruline. The MFDS reviews the Altruline KDMF as part of the drug registration process and uses the information provided in the Altruline KDMF to evaluate the safety and efficacy of the drug.
After submitting a Altruline 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 Altruline API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Altruline suppliers with KDMF on PharmaCompass.
A Altruline CEP of the European Pharmacopoeia monograph is often referred to as a Altruline Certificate of Suitability (COS). The purpose of a Altruline CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Altruline EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Altruline to their clients by showing that a Altruline CEP has been issued for it. The manufacturer submits a Altruline CEP (COS) as part of the market authorization procedure, and it takes on the role of a Altruline CEP holder for the record. Additionally, the data presented in the Altruline CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Altruline DMF.
A Altruline CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Altruline 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 Altruline suppliers with CEP (COS) on PharmaCompass.
A Altruline written confirmation (Altruline WC) is an official document issued by a regulatory agency to a Altruline manufacturer, verifying that the manufacturing facility of a Altruline active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Altruline APIs or Altruline finished pharmaceutical products to another nation, regulatory agencies frequently require a Altruline WC (written confirmation) as part of the regulatory process.
click here to find a list of Altruline 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 Altruline as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Altruline 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 Altruline 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 Altruline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Altruline NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Altruline suppliers with NDC on PharmaCompass.
Altruline 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 Altruline 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 Altruline GMP manufacturer or Altruline GMP API supplier for your needs.
A Altruline CoA (Certificate of Analysis) is a formal document that attests to Altruline's compliance with Altruline specifications and serves as a tool for batch-level quality control.
Altruline CoA mostly includes findings from lab analyses of a specific batch. For each Altruline 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.
Altruline may be tested according to a variety of international standards, such as European Pharmacopoeia (Altruline EP), Altruline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Altruline USP).
