Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
01 2Nuray Chemicals Private Limited
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1Neuland Laboratories
04 1Aurobindo Pharma Limited
05 1Aurore Life Sciences
06 2Cipla
07 1Glenmark Life Sciences
08 1MSN Laboratories
09 1Saptagir Laboratories
10 1Sun Pharmaceutical Industries Limited
11 1Teva Pharmaceutical Industries
01 10TAFAMIDIS
02 1TAFAMIDIS (CC)
03 1TAFAMIDIS (FORM-4)
04 1TAFAMIDIS (I)
01 12India
02 1Israel
01 13Active
01 8Complete
02 5Blank
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-01
Pay. Date : 2020-09-15
DMF Number : 35067
Submission : 2020-09-18
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-31
Pay. Date : 2023-03-21
DMF Number : 37694
Submission : 2022-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38240
Submission : 2023-03-31
Status : Active
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-28
Pay. Date : 2023-02-08
DMF Number : 36953
Submission : 2023-02-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37480
Submission : 2022-10-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-03
Pay. Date : 2023-01-25
DMF Number : 37667
Submission : 2022-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-13
Pay. Date : 2023-01-25
DMF Number : 37686
Submission : 2022-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37523
Submission : 2023-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-15
Pay. Date : 2023-04-10
DMF Number : 34736
Submission : 2020-03-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-19
Pay. Date : 2022-11-18
DMF Number : 37717
Submission : 2023-01-05
Status : Active
Type : II
A Tafamidis manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tafamidis, including repackagers and relabelers. The FDA regulates Tafamidis manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tafamidis 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 Tafamidis manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tafamidis supplier is an individual or a company that provides Tafamidis active pharmaceutical ingredient (API) or Tafamidis finished formulations upon request. The Tafamidis suppliers may include Tafamidis API manufacturers, exporters, distributors and traders.
click here to find a list of Tafamidis suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tafamidis DMF (Drug Master File) is a document detailing the whole manufacturing process of Tafamidis active pharmaceutical ingredient (API) in detail. Different forms of Tafamidis DMFs exist exist since differing nations have different regulations, such as Tafamidis USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tafamidis DMF submitted to regulatory agencies in the US is known as a USDMF. Tafamidis USDMF includes data on Tafamidis's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tafamidis USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tafamidis suppliers with USDMF on PharmaCompass.
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