Century has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.
01 1Century Pharmaceuticals
02 1TAPI Technology & API Services
03 2Alembic Pharmaceuticals Limited
04 1Calyx Chemicals & Pharmaceuticals Limited
05 1HEC Pharm
06 1Jubilant Generics
07 1Kopran
08 1Lupin Ltd
09 1Shanghai Shyndec Pharmaceutical
10 1Zhejiang Guobang Pharmaceutical
01 4AZITHROMYCIN DIHYDRATE
02 1AZITHROMYCIN DIHYDRATE NON-STERILE DRUG SUBSTANCE BULK FORM
03 5AZITHROMYCIN DIHYDRATE USP
04 1AZITHROMYCIN DIHYDRATE USP (ADF PROCESS)
01 3China
02 7India
03 1Israel
01 11Active
01 8Complete
02 3Blank
Century has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34583
Submission : 2020-03-09
Status : Active
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 : 2015-01-13
Pay. Date : 2014-04-25
DMF Number : 15972
Submission : 2002-05-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-15
Pay. Date : 2020-09-04
DMF Number : 35034
Submission : 2020-07-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-12
Pay. Date : 2016-01-28
DMF Number : 20754
Submission : 2007-07-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-09
Pay. Date : 2014-12-30
DMF Number : 28837
Submission : 2014-10-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-28
Pay. Date : 2017-03-01
DMF Number : 30966
Submission : 2016-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34853
Submission : 2020-05-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-10
Pay. Date : 2019-01-30
DMF Number : 33484
Submission : 2019-02-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-09-13
Pay. Date : 2021-06-24
DMF Number : 30887
Submission : 2016-12-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-08
Pay. Date : 2023-09-22
DMF Number : 36895
Submission : 2022-03-08
Status : Active
Type : II
A Azithromycin Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azithromycin Dihydrate, including repackagers and relabelers. The FDA regulates Azithromycin Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azithromycin Dihydrate 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 Azithromycin Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azithromycin Dihydrate supplier is an individual or a company that provides Azithromycin Dihydrate active pharmaceutical ingredient (API) or Azithromycin Dihydrate finished formulations upon request. The Azithromycin Dihydrate suppliers may include Azithromycin Dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Azithromycin Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Azithromycin Dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Azithromycin Dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Azithromycin Dihydrate DMFs exist exist since differing nations have different regulations, such as Azithromycin Dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azithromycin Dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Azithromycin Dihydrate USDMF includes data on Azithromycin Dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azithromycin Dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Azithromycin Dihydrate suppliers with USDMF on PharmaCompass.
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