01 2Apotex Pharmachem
02 1Aurore Life Sciences
03 1Azico Biophore India Pvt. Ltd
04 1Fareva
05 1GLAND PHARMA LIMITED
06 1Lupin Ltd
07 1MSN Laboratories
08 1Macleods Pharmaceuticals Limited
09 1Peptido GmbH
10 1Rhodia Organique SAS
11 1SAFC
12 1Sandoz B2B
13 2Blank
01 1"LEVOTHYROXINE SODIUM USP"
02 5LEVOTHYROXINE SODIUM
03 7LEVOTHYROXINE SODIUM USP
04 1ML15
05 1THYROGLOBULIN, USP
01 2Canada
02 1France
03 1Germany
04 6India
05 1Luxembourg
06 1Switzerland
07 1U.S.A
08 2Blank
01 11Active
02 4Inactive
01 8Complete
02 7Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-12
Pay. Date : 2021-08-06
DMF Number : 34044
Submission : 2019-08-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-10
Pay. Date : 2015-05-05
DMF Number : 29098
Submission : 2015-03-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-23
Pay. Date : 2013-09-26
DMF Number : 24402
Submission : 2011-10-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-25
Pay. Date : 2015-08-17
DMF Number : 29550
Submission : 2015-07-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-13
Pay. Date : 2016-03-18
DMF Number : 30376
Submission : 2016-03-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-23
Pay. Date : 2017-03-06
DMF Number : 31203
Submission : 2017-01-31
Status : Active
Type : II
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29526
Submission : 2015-06-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-15
Pay. Date : 2012-12-21
DMF Number : 4789
Submission : 1983-01-06
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38129
Submission : 2023-05-06
Status : Active
Type : II
Portfolio PDF
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Corporate PDF
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.
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.
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.
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