ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Dr. Reddy's Laboratories
03 1ALP Pharm
04 1Aurisco Pharmaceutical
05 1Aurobindo Pharma Limited
06 1Cdymax
07 1Chongqing Pharmaceutical Research Institute Co Ltd
08 2Cipla
09 1Hetero Drugs
10 1Hubei Biocause Heilen Pharmaceutical Co., Ltd
11 1Hubei Gedian Humanwell Pharmaceutical
12 2Industriale Chimica
13 3MSN Laboratories
14 1Olon S.p.A
15 1Qilu Antibiotics Pharmaceutical Co., Ltd.
16 1Raks Pharma
17 1ScinoPharm Taiwan, Ltd
18 1Shandong Sito Bio-technology Co ltd
19 2Sterling Spa
20 1Sun Pharmaceutical Industries Limited
21 1Teva Pharmaceutical Industries
22 1Tianjin Weijie Pharmaceutical Co., Ltd.
23 1Zhejiang Shenzhou Pharmaceutical
01 1ABIRATERONE
02 16ABIRATERONE ACETATE
03 1ABIRATERONE ACETATE (NON-STERILE BULK DRUG SUBSTANCE)
04 1ABIRATERONE ACETATE (NON-STERILE)
05 1ABIRATERONE ACETATE API
06 6ABIRATERONE ACETATE USP
07 1ABIRATERONE ACETATE USP (NP)
08 1ABIRATERONE ACETATE USP [ROUTE CODE - "AY"]
01 9China
02 11India
03 1Israel
04 5Italy
05 1Taiwan
06 1U.S.A
01 25Active
02 3Inactive
01 16Complete
02 12Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-13
Pay. Date : 2014-08-04
DMF Number : 26894
Submission : 2014-07-30
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-13
Pay. Date : 2014-05-05
DMF Number : 28038
Submission : 2014-03-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28292
Submission : 2014-06-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-13
Pay. Date : 2014-12-23
DMF Number : 28383
Submission : 2014-06-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-09
Pay. Date : 2022-06-16
DMF Number : 27853
Submission : 2013-12-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-10-14
DMF Number : 28701
Submission : 2014-10-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-12
Pay. Date : 2014-06-27
DMF Number : 27829
Submission : 2013-12-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2013-09-06
DMF Number : 27376
Submission : 2013-08-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-01
Pay. Date : 2013-01-10
DMF Number : 26725
Submission : 2012-11-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-30
Pay. Date : 2014-04-25
DMF Number : 27989
Submission : 2014-02-12
Status : Active
Type : II
A Abiraterone Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Abiraterone Acetate, including repackagers and relabelers. The FDA regulates Abiraterone Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Abiraterone Acetate 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 Abiraterone Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Abiraterone Acetate supplier is an individual or a company that provides Abiraterone Acetate active pharmaceutical ingredient (API) or Abiraterone Acetate finished formulations upon request. The Abiraterone Acetate suppliers may include Abiraterone Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Abiraterone Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Abiraterone Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Abiraterone Acetate active pharmaceutical ingredient (API) in detail. Different forms of Abiraterone Acetate DMFs exist exist since differing nations have different regulations, such as Abiraterone Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Abiraterone Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Abiraterone Acetate USDMF includes data on Abiraterone Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Abiraterone Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Abiraterone Acetate suppliers with USDMF on PharmaCompass.
We have 23 companies offering Abiraterone Acetate
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