ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Inke S.A
03 1Agno Pharma
04 1Apotex Pharmachem
05 1Centaur Pharmaceuticals
06 1CordenPharma
07 1F. Hoffmann-La Roche
08 1H. Lundbeck AS
09 1Hetero Drugs
10 1MSN Laboratories
11 1Piramal Pharma Solutions
12 1Rolabo Outsourcing
13 1Sun Pharmaceutical Industries Limited
14 2Viatris
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24946
Submission : 2011-10-18
Status :
Type : II
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37218
Submission : 2022-06-21
Status :
Type : II
A CAS-58-46-8 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-58-46-8, including repackagers and relabelers. The FDA regulates CAS-58-46-8 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-58-46-8 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 CAS-58-46-8 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CAS-58-46-8 supplier is an individual or a company that provides CAS-58-46-8 active pharmaceutical ingredient (API) or CAS-58-46-8 finished formulations upon request. The CAS-58-46-8 suppliers may include CAS-58-46-8 API manufacturers, exporters, distributors and traders.
click here to find a list of CAS-58-46-8 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CAS-58-46-8 DMF (Drug Master File) is a document detailing the whole manufacturing process of CAS-58-46-8 active pharmaceutical ingredient (API) in detail. Different forms of CAS-58-46-8 DMFs exist exist since differing nations have different regulations, such as CAS-58-46-8 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CAS-58-46-8 DMF submitted to regulatory agencies in the US is known as a USDMF. CAS-58-46-8 USDMF includes data on CAS-58-46-8's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CAS-58-46-8 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CAS-58-46-8 suppliers with USDMF on PharmaCompass.
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