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GDUFA

DMF Review : Complete

Rev. Date : 2013-01-30

Pay. Date : 2013-01-15

DMF Number : 14715

Submission : 2000-02-01

Status : Active

Type : II

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DMF Review : N/A

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DMF Number : 38129

Submission : 2023-05-06

Status : Active

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

Levothyroxine Sodium manufacturers, exporters & distributors 1

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.

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 Manufacturers

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

Levothyroxine Suppliers

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

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

Levothyroxine USDMF

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

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

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

Levothyroxine Manufacturers | Traders | Suppliers

Levothyroxine Manufacturers, Traders, Suppliers 1
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.