Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
01 1Nuray Chemicals Private Limited
02 13M Company
03 3AMINO GmbH
04 1SIGMA TAU
01 1BETAFINE® PLEATED POLYPROLYLENE CARTRIDGE PRODUCTS (BETAFINE® D SERIES, BETAFINE® XL SERIES, AND BETAFINE® PP & PG SERIES)
02 1BETAINE
03 1BETAINE ANHYDROUS
04 1BETAINE FREE BASE ANHYDROUS PURCHASED BY SIGMA LTD LONDON FOR USA
05 1BETAINE PHARMACEUTICAL GRADE
06 1BETAINE, MONOHYDRATE
01 3Germany
02 1India
03 2U.S.A
01 4Active
02 2Inactive
01 2Complete
02 4Blank
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 : 2020-04-24
Pay. Date : 2020-03-10
DMF Number : 34404
Submission : 2020-03-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15348
Submission : 2001-03-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-01
Pay. Date : 2017-10-27
DMF Number : 31655
Submission : 2017-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11079
Submission : 1994-09-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11069
Submission : 1994-09-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5082
Submission : 1983-09-30
Status : Inactive
Type : II
A Betaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betaine, including repackagers and relabelers. The FDA regulates Betaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betaine 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 Betaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betaine supplier is an individual or a company that provides Betaine active pharmaceutical ingredient (API) or Betaine finished formulations upon request. The Betaine suppliers may include Betaine API manufacturers, exporters, distributors and traders.
click here to find a list of Betaine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Betaine DMF (Drug Master File) is a document detailing the whole manufacturing process of Betaine active pharmaceutical ingredient (API) in detail. Different forms of Betaine DMFs exist exist since differing nations have different regulations, such as Betaine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betaine DMF submitted to regulatory agencies in the US is known as a USDMF. Betaine USDMF includes data on Betaine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betaine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betaine suppliers with USDMF on PharmaCompass.
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