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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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Aspen API. More than just an API™
Regulatory Info :
Registration Country : Sweden
levothyroxine sodium (hydrate)
Brand Name : Eltroxin
Dosage Form : TABLET
Dosage Strength : 125 MICROGRAMS
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Sweden
levothyroxine sodium (hydrate)
Brand Name : Eltroxin
Dosage Form : TABLET
Dosage Strength : 150 MICROGRAM
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Sweden
levothyroxine sodium (hydrate)
Brand Name : Eltroxin
Dosage Form : TABLET
Dosage Strength : 75 MICROGRAMS
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Sweden
levothyroxine sodium (hydrate)
Brand Name : Eltroxin
Dosage Form : TABLET
Dosage Strength : 100 MICROGRAMS
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Sweden
levothyroxine sodium (hydrate)
Brand Name : Eltroxin
Dosage Form : TABLET
Dosage Strength : 175 MICROGRAMS
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Sweden
levothyroxine sodium (hydrate)
Brand Name : Eltroxin
Dosage Form : TABLET
Dosage Strength : 200 MICROGRAM
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Sweden
levothyroxine sodium (hydrate)
Brand Name : Eltroxin
Dosage Form : TABLET
Dosage Strength : 50 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Sweden
levothyroxine sodium (hydrate)
Brand Name : Eltroxin
Dosage Form : TABLET
Dosage Strength : 25 MICROGRAMS
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ELTROXIN
Dosage Form : TABLET
Dosage Strength : 50MCG
Packaging : 500
Approval Date :
Application Number : 2213192
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ELTROXIN
Dosage Form : TABLET
Dosage Strength : 100MCG
Packaging : 500
Approval Date :
Application Number : 2213206
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ELTROXIN
Dosage Form : TABLET
Dosage Strength : 150MCG
Packaging : 500
Approval Date :
Application Number : 2213214
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ELTROXIN
Dosage Form : TABLET
Dosage Strength : 200MCG
Packaging : 500
Approval Date :
Application Number : 2213222
Regulatory Info : Prescription
Registration Country : Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Eltroxin
Dosage Form :
Dosage Strength :
Packaging : 200
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Oroxine
Dosage Form :
Dosage Strength :
Packaging : 200
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Eutroxsig
Dosage Form :
Dosage Strength :
Packaging : 200
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Oroxine
Dosage Form :
Dosage Strength :
Packaging : 200
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Eutroxsig
Dosage Form :
Dosage Strength :
Packaging : 200
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Eltroxin
Dosage Form :
Dosage Strength :
Packaging : 200
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Oroxine
Dosage Form :
Dosage Strength :
Packaging : 200
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Eltroxin
Dosage Form :
Dosage Strength :
Packaging : 200
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Oroxine
Dosage Form :
Dosage Strength :
Packaging : 200
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Eutroxsig
Dosage Form :
Dosage Strength :
Packaging : 200
Approval Date :
Application Number :
Regulatory Info :
Registration Country : 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 - 0.0125MG;0.0031MG
USFDA APPLICATION NUMBER - 16807
DOSAGE - TABLET;ORAL - 0.025MG;0.0063MG
USFDA APPLICATION NUMBER - 16807
DOSAGE - TABLET;ORAL - 0.05MG;0.0125MG
USFDA APPLICATION NUMBER - 16807
DOSAGE - TABLET;ORAL - 0.15MG;0.0375MG
USFDA APPLICATION NUMBER - 16807
DOSAGE - TABLET;ORAL - 0.1MG;0.025MG
USFDA APPLICATION NUMBER - 16807
DOSAGE - POWDER;INTRAVENOUS - 100MCG/VIAL
USFDA APPLICATION NUMBER - 202231
DOSAGE - POWDER;INTRAVENOUS - 200MCG/VIAL
USFDA APPLICATION NUMBER - 202231
DOSAGE - POWDER;INTRAVENOUS - 500MCG/VIAL
USFDA APPLICATION NUMBER - 202231
DOSAGE - TABLET;ORAL - 0.025MG **See current ...DOSAGE - TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.05MG **See current A...DOSAGE - TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.075MG **See current ...DOSAGE - TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.088MG **See current ...DOSAGE - TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.112MG **See current ...DOSAGE - TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.125MG **See current ...DOSAGE - TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.137MG **See current ...DOSAGE - TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.15MG **See current A...DOSAGE - TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.175MG **See current ...DOSAGE - TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.1MG **See current An...DOSAGE - TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.2MG **See current An...DOSAGE - TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.3MG **See current An...DOSAGE - TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.025MG **See current ...DOSAGE - TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.05MG **See current A...DOSAGE - TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.075MG **See current ...DOSAGE - TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.088MG **See current ...DOSAGE - TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.112MG **See current ...DOSAGE - TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.125MG **See current ...DOSAGE - TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.137MG **See current ...DOSAGE - TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.15MG **See current A...DOSAGE - TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.175MG **See current ...DOSAGE - TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.1MG **See current An...DOSAGE - TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.2MG **See current An...DOSAGE - TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.3MG **See current An...DOSAGE - TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.025MG **See current ...DOSAGE - TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.05MG **See current A...DOSAGE - TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.075MG **See current ...DOSAGE - TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.088MG **See current ...DOSAGE - TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.112MG **See current ...DOSAGE - TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.125MG **See current ...DOSAGE - TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.137MG **See current ...DOSAGE - TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.15MG **See current A...DOSAGE - TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.175MG **See current ...DOSAGE - TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.1MG **See current An...DOSAGE - TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.2MG **See current An...DOSAGE - TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.3MG **See current An...DOSAGE - TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - CAPSULE;ORAL - 0.013MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.025MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.0375MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.044MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.05MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.0625MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.075MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.088MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.112MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.125MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.137MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.15MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.175MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.1MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.2MG
USFDA APPLICATION NUMBER - 21924
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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
ABOUT THIS PAGE
24
PharmaCompass offers a list of Levothyroxine Sodium 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 Levothyroxine Sodium manufacturer or Levothyroxine Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Levothyroxine Sodium manufacturer or Levothyroxine Sodium supplier.
PharmaCompass also assists you with knowing the Levothyroxine Sodium API Price utilized in the formulation of products. Levothyroxine Sodium API Price is not always fixed or binding as the Levothyroxine Sodium Price is obtained through a variety of data sources. The Levothyroxine Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Levo T manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levo T, including repackagers and relabelers. The FDA regulates Levo T manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levo T 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 Levo T manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levo T supplier is an individual or a company that provides Levo T active pharmaceutical ingredient (API) or Levo T finished formulations upon request. The Levo T suppliers may include Levo T API manufacturers, exporters, distributors and traders.
click here to find a list of Levo T suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levo T DMF (Drug Master File) is a document detailing the whole manufacturing process of Levo T active pharmaceutical ingredient (API) in detail. Different forms of Levo T DMFs exist exist since differing nations have different regulations, such as Levo T USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levo T DMF submitted to regulatory agencies in the US is known as a USDMF. Levo T USDMF includes data on Levo T's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levo T USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levo T 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 Levo T Drug Master File in Japan (Levo T JDMF) empowers Levo T 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 Levo T JDMF during the approval evaluation for pharmaceutical products. At the time of Levo T 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 Levo T 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 Levo T Drug Master File in Korea (Levo T KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Levo T. The MFDS reviews the Levo T KDMF as part of the drug registration process and uses the information provided in the Levo T KDMF to evaluate the safety and efficacy of the drug.
After submitting a Levo T 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 Levo T API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Levo T suppliers with KDMF on PharmaCompass.
A Levo T CEP of the European Pharmacopoeia monograph is often referred to as a Levo T Certificate of Suitability (COS). The purpose of a Levo T CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Levo T EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Levo T to their clients by showing that a Levo T CEP has been issued for it. The manufacturer submits a Levo T CEP (COS) as part of the market authorization procedure, and it takes on the role of a Levo T CEP holder for the record. Additionally, the data presented in the Levo T CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Levo T DMF.
A Levo T CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Levo T 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 Levo T suppliers with CEP (COS) on PharmaCompass.
A Levo T written confirmation (Levo T WC) is an official document issued by a regulatory agency to a Levo T manufacturer, verifying that the manufacturing facility of a Levo T active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Levo T APIs or Levo T finished pharmaceutical products to another nation, regulatory agencies frequently require a Levo T WC (written confirmation) as part of the regulatory process.
click here to find a list of Levo T 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 Levo T as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Levo T 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 Levo T 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 Levo T and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Levo T NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Levo T suppliers with NDC on PharmaCompass.
Levo T 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 Levo T 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 Levo T GMP manufacturer or Levo T GMP API supplier for your needs.
A Levo T CoA (Certificate of Analysis) is a formal document that attests to Levo T's compliance with Levo T specifications and serves as a tool for batch-level quality control.
Levo T CoA mostly includes findings from lab analyses of a specific batch. For each Levo T 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.
Levo T may be tested according to a variety of international standards, such as European Pharmacopoeia (Levo T EP), Levo T JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levo T USP).
