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  • TABLET;ORAL - 0.0125MG;0.0031MG
  • TABLET;ORAL - 0.025MG;0.0063MG
  • TABLET;ORAL - 0.05MG;0.0125MG
  • TABLET;ORAL - 0.15MG;0.0375MG
  • TABLET;ORAL - 0.1MG;0.025MG
  • POWDER;INTRAVENOUS - 100MCG/VIAL
  • POWDER;INTRAVENOUS - 200MCG/VIAL
  • POWDER;INTRAVENOUS - 500MCG/VIAL
  • TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • CAPSULE;ORAL - 0.013MG
  • CAPSULE;ORAL - 0.025MG
  • CAPSULE;ORAL - 0.0375MG
  • CAPSULE;ORAL - 0.044MG
  • CAPSULE;ORAL - 0.05MG
  • CAPSULE;ORAL - 0.0625MG
  • CAPSULE;ORAL - 0.075MG
  • CAPSULE;ORAL - 0.088MG
  • CAPSULE;ORAL - 0.112MG
  • CAPSULE;ORAL - 0.125MG
  • CAPSULE;ORAL - 0.137MG
  • CAPSULE;ORAL - 0.15MG
  • CAPSULE;ORAL - 0.175MG
  • CAPSULE;ORAL - 0.1MG
  • CAPSULE;ORAL - 0.2MG

Looking for 31178-59-3 / Levothyroxine Sodium API manufacturers, exporters & distributors?

Levothyroxine Sodium manufacturers, exporters & distributors 1

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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.

API | Excipient name

Levothyroxine Sodium

Synonyms

25416-65-3, L-thyroxine sodium xhydrate, Levothyroxine sodium hydrate, L-thyroxine sodium hydrate, Monosodium l-thyroxine hydrate, 31178-59-3

Cas Number

31178-59-3

Unique Ingredient Identifier (UNII)

B82379R9W0

About Levothyroxine Sodium

The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism.

Levothyroxine Sodium Manufacturers

A Levothyroxine Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levothyroxine Sodium, including repackagers and relabelers. The FDA regulates Levothyroxine Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levothyroxine Sodium 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 Levothyroxine Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Levothyroxine Sodium Suppliers

A Levothyroxine Sodium supplier is an individual or a company that provides Levothyroxine Sodium active pharmaceutical ingredient (API) or Levothyroxine Sodium finished formulations upon request. The Levothyroxine Sodium suppliers may include Levothyroxine Sodium API manufacturers, exporters, distributors and traders.

click here to find a list of Levothyroxine Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Levothyroxine Sodium USDMF

A Levothyroxine Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Levothyroxine Sodium active pharmaceutical ingredient (API) in detail. Different forms of Levothyroxine Sodium DMFs exist exist since differing nations have different regulations, such as Levothyroxine Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Levothyroxine Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Levothyroxine Sodium USDMF includes data on Levothyroxine Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levothyroxine Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Levothyroxine Sodium suppliers with USDMF on PharmaCompass.

Levothyroxine Sodium JDMF

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 Levothyroxine Sodium Drug Master File in Japan (Levothyroxine Sodium JDMF) empowers Levothyroxine Sodium 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 Levothyroxine Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Levothyroxine Sodium 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 Levothyroxine Sodium suppliers with JDMF on PharmaCompass.

Levothyroxine Sodium KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Levothyroxine Sodium Drug Master File in Korea (Levothyroxine Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Levothyroxine Sodium. The MFDS reviews the Levothyroxine Sodium KDMF as part of the drug registration process and uses the information provided in the Levothyroxine Sodium KDMF to evaluate the safety and efficacy of the drug.

After submitting a Levothyroxine Sodium 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 Levothyroxine Sodium API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Levothyroxine Sodium suppliers with KDMF on PharmaCompass.

Levothyroxine Sodium CEP

A Levothyroxine Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Levothyroxine Sodium Certificate of Suitability (COS). The purpose of a Levothyroxine Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Levothyroxine Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Levothyroxine Sodium to their clients by showing that a Levothyroxine Sodium CEP has been issued for it. The manufacturer submits a Levothyroxine Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Levothyroxine Sodium CEP holder for the record. Additionally, the data presented in the Levothyroxine Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Levothyroxine Sodium DMF.

A Levothyroxine Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Levothyroxine Sodium 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 Levothyroxine Sodium suppliers with CEP (COS) on PharmaCompass.

Levothyroxine Sodium WC

A Levothyroxine Sodium written confirmation (Levothyroxine Sodium WC) is an official document issued by a regulatory agency to a Levothyroxine Sodium manufacturer, verifying that the manufacturing facility of a Levothyroxine Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Levothyroxine Sodium APIs or Levothyroxine Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Levothyroxine Sodium WC (written confirmation) as part of the regulatory process.

click here to find a list of Levothyroxine Sodium suppliers with Written Confirmation (WC) on PharmaCompass.

Levothyroxine Sodium NDC

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 Levothyroxine Sodium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Levothyroxine Sodium API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Levothyroxine Sodium 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Levothyroxine Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Levothyroxine Sodium NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Levothyroxine Sodium suppliers with NDC on PharmaCompass.

Levothyroxine Sodium GMP

Levothyroxine Sodium 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 Levothyroxine Sodium 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 Levothyroxine Sodium GMP manufacturer or Levothyroxine Sodium GMP API supplier for your needs.

Levothyroxine Sodium CoA

A Levothyroxine Sodium CoA (Certificate of Analysis) is a formal document that attests to Levothyroxine Sodium's compliance with Levothyroxine Sodium specifications and serves as a tool for batch-level quality control.

Levothyroxine Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Levothyroxine Sodium 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.

Levothyroxine Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Levothyroxine Sodium EP), Levothyroxine Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levothyroxine Sodium USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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