Axplora- The partner of choice for complex APIs.
01 2Axplora
02 1Symbiotec Pharmalab
03 1Sanofi
04 3TAPI Technology & API Services
05 1ACS DOBFAR SPA
06 1ALP Pharm
07 1Amphastar Pharmaceuticals
08 2Cipla
09 1Henan Lihua Pharmaceutical
10 3Hovione
11 1Mahima Life Sciences
12 1Quimica Sintetica
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-25
Pay. Date : 2019-04-22
DMF Number : 12813
Submission : 1998-01-05
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28137
Submission : 2014-03-20
Status :
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8036
Submission : 1989-04-28
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2019-01-31
Pay. Date : 2019-01-28
DMF Number : 4871
Submission : 1983-03-14
Status :
Type : II
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21972
Submission : 2008-09-11
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16934
Submission : 2003-10-20
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13965
Submission : 1999-01-29
Status :
Type : II
A Beclomethasone Dipropionate Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Beclomethasone Dipropionate Monohydrate, including repackagers and relabelers. The FDA regulates Beclomethasone Dipropionate Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Beclomethasone Dipropionate Monohydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Beclomethasone Dipropionate Monohydrate supplier is an individual or a company that provides Beclomethasone Dipropionate Monohydrate active pharmaceutical ingredient (API) or Beclomethasone Dipropionate Monohydrate finished formulations upon request. The Beclomethasone Dipropionate Monohydrate suppliers may include Beclomethasone Dipropionate Monohydrate API manufacturers, exporters, distributors and traders.
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A Beclomethasone Dipropionate Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Beclomethasone Dipropionate Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Beclomethasone Dipropionate Monohydrate DMFs exist exist since differing nations have different regulations, such as Beclomethasone Dipropionate Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Beclomethasone Dipropionate Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Beclomethasone Dipropionate Monohydrate USDMF includes data on Beclomethasone Dipropionate Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Beclomethasone Dipropionate Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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