Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Dr. Reddy's Laboratories
03 1TAPI Technology & API Services
04 1Apicore LLC
05 1Cipla
06 1GLAND CHEMICALS PRIVATE LIMITED
07 1Hainan Shuangcheng Pharmaceuticals
08 1Hansoh Pharma
09 2Hetero Drugs
10 1Hubei Honch Pharmaceutical
11 1Laurus Labs
12 2MSN Laboratories
13 1Natco Pharma
14 1Polymed Therapeutics Inc.
15 1Qilu Pharmaceutical
16 1Reliance Life Sciences Private Limited
17 1SEACROSS PHARMACEUTICALS
18 1ScinoPharm Taiwan, Ltd
19 2Shilpa Medicare
20 1Shivalik Rasayan
21 1Sun Pharmaceutical Industries Limited
22 1Viwit Pharmaceuticals Limited
23 1Zhejiang Hisun Pharmaceutical
24 1Blank
01 22BORTEZOMIB
02 2BORTEZOMIB (FORM-II)
03 1BORTEZOMIB (NON-STERILE, API)
04 1BORTEZOMIB DRUG SUBSTANCE
05 1BORTEZOMIB [ROUTE CODE "BR"]
01 6China
02 16India
03 1Israel
04 1Taiwan
05 1U.S.A
06 1United Kingdom
07 1Blank
01 22Active
02 5Inactive
01 18Complete
02 9Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-04
Pay. Date : 2015-09-09
DMF Number : 29506
Submission : 2015-08-27
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 : 2023-06-30
Pay. Date : 2023-06-27
DMF Number : 23996
Submission : 2010-07-26
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 : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 22160
Submission : 2008-10-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-22
Pay. Date : 2013-09-20
DMF Number : 22922
Submission : 2009-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-06
Pay. Date : 2013-02-20
DMF Number : 26440
Submission : 2012-10-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-06
Pay. Date : 2012-12-18
DMF Number : 26774
Submission : 2012-12-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-03
Pay. Date : 2016-01-21
DMF Number : 26547
Submission : 2012-12-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-06
Pay. Date : 2018-03-28
DMF Number : 26282
Submission : 2012-08-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-13
Pay. Date : 2016-08-18
DMF Number : 25665
Submission : 2011-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-31
Pay. Date : 2013-02-13
DMF Number : 24944
Submission : 2011-08-23
Status : Active
Type : II
A Velcade manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Velcade, including repackagers and relabelers. The FDA regulates Velcade manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Velcade 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 Velcade manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Velcade supplier is an individual or a company that provides Velcade active pharmaceutical ingredient (API) or Velcade finished formulations upon request. The Velcade suppliers may include Velcade API manufacturers, exporters, distributors and traders.
click here to find a list of Velcade suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Velcade DMF (Drug Master File) is a document detailing the whole manufacturing process of Velcade active pharmaceutical ingredient (API) in detail. Different forms of Velcade DMFs exist exist since differing nations have different regulations, such as Velcade USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Velcade DMF submitted to regulatory agencies in the US is known as a USDMF. Velcade USDMF includes data on Velcade's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Velcade USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Velcade suppliers with USDMF on PharmaCompass.
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