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API SUPPLIERS
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USDMF
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DOSAGE - FOR SOLUTION;ORAL - 12GM/PACKET;3.5G...DOSAGE - FOR SOLUTION;ORAL - 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 202535
DOSAGE - SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;1...DOSAGE - SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;10MG/BOT
USFDA APPLICATION NUMBER - 209589
Related Excipient Companies
Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
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Parenteral
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US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Sodium Picosulfate 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 Sodium Picosulfate manufacturer or Sodium Picosulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Picosulfate manufacturer or Sodium Picosulfate supplier.
A Laxoberon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Laxoberon, including repackagers and relabelers. The FDA regulates Laxoberon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Laxoberon 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 Laxoberon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Laxoberon supplier is an individual or a company that provides Laxoberon active pharmaceutical ingredient (API) or Laxoberon finished formulations upon request. The Laxoberon suppliers may include Laxoberon API manufacturers, exporters, distributors and traders.
click here to find a list of Laxoberon suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Laxoberon DMF (Drug Master File) is a document detailing the whole manufacturing process of Laxoberon active pharmaceutical ingredient (API) in detail. Different forms of Laxoberon DMFs exist exist since differing nations have different regulations, such as Laxoberon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Laxoberon DMF submitted to regulatory agencies in the US is known as a USDMF. Laxoberon USDMF includes data on Laxoberon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Laxoberon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Laxoberon 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 Laxoberon Drug Master File in Japan (Laxoberon JDMF) empowers Laxoberon 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 Laxoberon JDMF during the approval evaluation for pharmaceutical products. At the time of Laxoberon 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 Laxoberon 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 Laxoberon Drug Master File in Korea (Laxoberon KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Laxoberon. The MFDS reviews the Laxoberon KDMF as part of the drug registration process and uses the information provided in the Laxoberon KDMF to evaluate the safety and efficacy of the drug.
After submitting a Laxoberon 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 Laxoberon API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Laxoberon suppliers with KDMF on PharmaCompass.
A Laxoberon CEP of the European Pharmacopoeia monograph is often referred to as a Laxoberon Certificate of Suitability (COS). The purpose of a Laxoberon CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Laxoberon EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Laxoberon to their clients by showing that a Laxoberon CEP has been issued for it. The manufacturer submits a Laxoberon CEP (COS) as part of the market authorization procedure, and it takes on the role of a Laxoberon CEP holder for the record. Additionally, the data presented in the Laxoberon CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Laxoberon DMF.
A Laxoberon CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Laxoberon 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 Laxoberon suppliers with CEP (COS) on PharmaCompass.
A Laxoberon written confirmation (Laxoberon WC) is an official document issued by a regulatory agency to a Laxoberon manufacturer, verifying that the manufacturing facility of a Laxoberon active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Laxoberon APIs or Laxoberon finished pharmaceutical products to another nation, regulatory agencies frequently require a Laxoberon WC (written confirmation) as part of the regulatory process.
click here to find a list of Laxoberon 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 Laxoberon as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Laxoberon 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 Laxoberon 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 Laxoberon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Laxoberon NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Laxoberon suppliers with NDC on PharmaCompass.
Laxoberon 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 Laxoberon GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Laxoberon GMP manufacturer or Laxoberon GMP API supplier for your needs.
A Laxoberon CoA (Certificate of Analysis) is a formal document that attests to Laxoberon's compliance with Laxoberon specifications and serves as a tool for batch-level quality control.
Laxoberon CoA mostly includes findings from lab analyses of a specific batch. For each Laxoberon 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.
Laxoberon may be tested according to a variety of international standards, such as European Pharmacopoeia (Laxoberon EP), Laxoberon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Laxoberon USP).
