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API SUPPLIERS
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USDMF
Maithri Drugs: Dedicated to your API needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40138
Submission : 2024-06-27
Status :
Type : II
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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DOSAGE - POWDER;ORAL - 1.6GM/BOT;3.13GM/BOT;1...DOSAGE - POWDER;ORAL - 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
USFDA APPLICATION NUMBER - 204553
DOSAGE - TABLET;ORAL - 0.225GM;0.188GM;1.479G...DOSAGE - TABLET;ORAL - 0.225GM;0.188GM;1.479GM
USFDA APPLICATION NUMBER - 213135
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Tablet
Grade : Oral
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Parenteral
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ABOUT THIS PAGE
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PharmaCompass offers a list of Sodium Sulfate 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 Sodium Sulfate manufacturer or Sodium Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Sulfate manufacturer or Sodium Sulfate supplier.
PharmaCompass also assists you with knowing the Sodium Sulfate API Price utilized in the formulation of products. Sodium Sulfate API Price is not always fixed or binding as the Sodium Sulfate Price is obtained through a variety of data sources. The Sodium Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A SUPREP BOWEL PREP KIT-2 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SUPREP BOWEL PREP KIT-2, including repackagers and relabelers. The FDA regulates SUPREP BOWEL PREP KIT-2 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SUPREP BOWEL PREP KIT-2 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 SUPREP BOWEL PREP KIT-2 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SUPREP BOWEL PREP KIT-2 supplier is an individual or a company that provides SUPREP BOWEL PREP KIT-2 active pharmaceutical ingredient (API) or SUPREP BOWEL PREP KIT-2 finished formulations upon request. The SUPREP BOWEL PREP KIT-2 suppliers may include SUPREP BOWEL PREP KIT-2 API manufacturers, exporters, distributors and traders.
click here to find a list of SUPREP BOWEL PREP KIT-2 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SUPREP BOWEL PREP KIT-2 DMF (Drug Master File) is a document detailing the whole manufacturing process of SUPREP BOWEL PREP KIT-2 active pharmaceutical ingredient (API) in detail. Different forms of SUPREP BOWEL PREP KIT-2 DMFs exist exist since differing nations have different regulations, such as SUPREP BOWEL PREP KIT-2 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SUPREP BOWEL PREP KIT-2 DMF submitted to regulatory agencies in the US is known as a USDMF. SUPREP BOWEL PREP KIT-2 USDMF includes data on SUPREP BOWEL PREP KIT-2's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SUPREP BOWEL PREP KIT-2 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SUPREP BOWEL PREP KIT-2 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 SUPREP BOWEL PREP KIT-2 Drug Master File in Japan (SUPREP BOWEL PREP KIT-2 JDMF) empowers SUPREP BOWEL PREP KIT-2 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 SUPREP BOWEL PREP KIT-2 JDMF during the approval evaluation for pharmaceutical products. At the time of SUPREP BOWEL PREP KIT-2 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 SUPREP BOWEL PREP KIT-2 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 SUPREP BOWEL PREP KIT-2 Drug Master File in Korea (SUPREP BOWEL PREP KIT-2 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of SUPREP BOWEL PREP KIT-2. The MFDS reviews the SUPREP BOWEL PREP KIT-2 KDMF as part of the drug registration process and uses the information provided in the SUPREP BOWEL PREP KIT-2 KDMF to evaluate the safety and efficacy of the drug.
After submitting a SUPREP BOWEL PREP KIT-2 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 SUPREP BOWEL PREP KIT-2 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of SUPREP BOWEL PREP KIT-2 suppliers with KDMF on PharmaCompass.
A SUPREP BOWEL PREP KIT-2 CEP of the European Pharmacopoeia monograph is often referred to as a SUPREP BOWEL PREP KIT-2 Certificate of Suitability (COS). The purpose of a SUPREP BOWEL PREP KIT-2 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of SUPREP BOWEL PREP KIT-2 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of SUPREP BOWEL PREP KIT-2 to their clients by showing that a SUPREP BOWEL PREP KIT-2 CEP has been issued for it. The manufacturer submits a SUPREP BOWEL PREP KIT-2 CEP (COS) as part of the market authorization procedure, and it takes on the role of a SUPREP BOWEL PREP KIT-2 CEP holder for the record. Additionally, the data presented in the SUPREP BOWEL PREP KIT-2 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the SUPREP BOWEL PREP KIT-2 DMF.
A SUPREP BOWEL PREP KIT-2 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. SUPREP BOWEL PREP KIT-2 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 SUPREP BOWEL PREP KIT-2 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 SUPREP BOWEL PREP KIT-2 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SUPREP BOWEL PREP KIT-2 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 SUPREP BOWEL PREP KIT-2 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 SUPREP BOWEL PREP KIT-2 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SUPREP BOWEL PREP KIT-2 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SUPREP BOWEL PREP KIT-2 suppliers with NDC on PharmaCompass.
SUPREP BOWEL PREP KIT-2 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 SUPREP BOWEL PREP KIT-2 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 SUPREP BOWEL PREP KIT-2 GMP manufacturer or SUPREP BOWEL PREP KIT-2 GMP API supplier for your needs.
A SUPREP BOWEL PREP KIT-2 CoA (Certificate of Analysis) is a formal document that attests to SUPREP BOWEL PREP KIT-2's compliance with SUPREP BOWEL PREP KIT-2 specifications and serves as a tool for batch-level quality control.
SUPREP BOWEL PREP KIT-2 CoA mostly includes findings from lab analyses of a specific batch. For each SUPREP BOWEL PREP KIT-2 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.
SUPREP BOWEL PREP KIT-2 may be tested according to a variety of international standards, such as European Pharmacopoeia (SUPREP BOWEL PREP KIT-2 EP), SUPREP BOWEL PREP KIT-2 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SUPREP BOWEL PREP KIT-2 USP).
