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USDMF
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40093
Submission : 2024-06-13
Status :
Type : II
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Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
About the Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & operation facilities ar...
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
About the Company : Specializing in natural & oncology APIs, we establish R&D and production platforms for new salt, crystal form & synthetic biology research. We cooperate with clients for IND, NDA, ...
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DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX AV01FG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX AV01PhG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01PhG is used as a coating and coloring agent in oral solids such as tablets, capsules, granules, and pellets.
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ABOUT THIS PAGE
A Alectinib Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alectinib Hydrochloride, including repackagers and relabelers. The FDA regulates Alectinib Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alectinib 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 Alectinib Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alectinib Hydrochloride supplier is an individual or a company that provides Alectinib Hydrochloride active pharmaceutical ingredient (API) or Alectinib Hydrochloride finished formulations upon request. The Alectinib Hydrochloride suppliers may include Alectinib Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Alectinib Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alectinib Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Alectinib Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Alectinib Hydrochloride DMFs exist exist since differing nations have different regulations, such as Alectinib Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alectinib Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Alectinib Hydrochloride USDMF includes data on Alectinib Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alectinib Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alectinib Hydrochloride suppliers with USDMF on PharmaCompass.
A Alectinib Hydrochloride written confirmation (Alectinib Hydrochloride WC) is an official document issued by a regulatory agency to a Alectinib Hydrochloride manufacturer, verifying that the manufacturing facility of a Alectinib Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Alectinib Hydrochloride APIs or Alectinib Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Alectinib Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Alectinib Hydrochloride 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 Alectinib Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alectinib 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 Alectinib 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 Alectinib Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alectinib Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alectinib Hydrochloride suppliers with NDC on PharmaCompass.
Alectinib 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 Alectinib 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 Alectinib Hydrochloride GMP manufacturer or Alectinib Hydrochloride GMP API supplier for your needs.
A Alectinib Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Alectinib Hydrochloride's compliance with Alectinib Hydrochloride specifications and serves as a tool for batch-level quality control.
Alectinib Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Alectinib 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.
Alectinib Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Alectinib Hydrochloride EP), Alectinib Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alectinib Hydrochloride USP).
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