ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Dr. Reddy's Laboratories
03 1TAPI Technology & API Services
04 1Archimica
05 1Ash Stevens
06 1Aurobindo Pharma Limited
07 1Hansoh Pharma
08 1Hetero Drugs
09 1ITF CHEMICAL LTDA
10 1Intas Pharmaceuticals
11 1Laurus Labs
12 1MSN Laboratories
13 1Polymed Therapeutics Inc.
14 1Qilu Antibiotics Pharmaceutical Co., Ltd.
15 1Reliance Life Sciences Private Limited
16 1ScinoPharm Taiwan, Ltd
17 1Shilpa Medicare
18 1Sun Pharmaceutical Industries Limited
19 1Viatris
20 2Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-26
Pay. Date : 2022-12-16
DMF Number : 23416
Submission : 2009-12-22
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-20
Pay. Date : 2020-11-17
DMF Number : 23564
Submission : 2010-02-23
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-24
Pay. Date : 2012-11-13
DMF Number : 26126
Submission : 2012-06-04
Status :
Type : II
A Azacitidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azacitidine, including repackagers and relabelers. The FDA regulates Azacitidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azacitidine 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 Azacitidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azacitidine supplier is an individual or a company that provides Azacitidine active pharmaceutical ingredient (API) or Azacitidine finished formulations upon request. The Azacitidine suppliers may include Azacitidine API manufacturers, exporters, distributors and traders.
click here to find a list of Azacitidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Azacitidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Azacitidine active pharmaceutical ingredient (API) in detail. Different forms of Azacitidine DMFs exist exist since differing nations have different regulations, such as Azacitidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azacitidine DMF submitted to regulatory agencies in the US is known as a USDMF. Azacitidine USDMF includes data on Azacitidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azacitidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Azacitidine suppliers with USDMF on PharmaCompass.
We have 19 companies offering Azacitidine
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