01 1ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN
02 1APITORIA PHARMA PRIVATE LIMITED Hyderabad IN
03 1APOTEX PHARMACHEM INDIA PVT. LTD Bangalore IN
04 1Amino Chemicals LTD. Marsa MT
05 2Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim Am Rhein DE
06 1CHR. OLESEN SYNTHESIS A/S Hvidovre DK
07 1CIPLA LIMITED Mumbai IN
08 1CURIA SPAIN S.A.U. Boecillo ES
09 1Erregierre S.p.A. San Paolo D'Argon IT
10 1HETERO DRUGS LIMITED Hyderabad IN
11 1MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN
12 1OLON S.P.A. Rodano IT
13 1PIRAMAL PHARMA LIMITED Digwal Village IN
14 1SYNTHON BV Nijmegen NL
15 1TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN
16 1Unichem Laboratories Limited Mumbai IN
17 1Wockhardt Limited Mumbai IN
01 17Pramipexole dihydrochloride monohydrate
02 1Pramipexole dihydrochloride monohydrate, Milled
01 1Canada
02 1Denmark
03 2Germany
04 8India
05 2Italy
06 1Malta
07 1Netherlands
08 2U.S.A
01 16Valid
02 2Withdrawn by Holder
Pramipexole Dihydrochloride Monohydrate
Certificate Number : R1-CEP 2011-190 - Rev 00
Status : Valid
Issue Date : 2018-04-20
Type : Chemical
Substance Number : 2416
Pramipexole Dihydrochloride Monohydrate
Certificate Number : R1-CEP 2011-127 - Rev 02
Status : Valid
Issue Date : 2018-09-25
Type : Chemical
Substance Number : 2416
Pramipexole Dihydrochloride Monohydrate
Certificate Number : R0-CEP 2019-186 - Rev 00
Status : Valid
Issue Date : 2020-04-02
Type : Chemical
Substance Number : 2416
Pramipexole Dihydrochloride Monohydrate
Certificate Number : CEP 2011-047 - Rev 03
Status : Valid
Issue Date : 2024-07-05
Type : Chemical
Substance Number : 2416
Pramipexole Dihydrochloride Monohydrate
Certificate Number : R1-CEP 2010-354 - Rev 01
Status : Valid
Issue Date : 2021-08-24
Type : Chemical
Substance Number : 2416
Pramipexole Dihydrochloride Monohydrate
Certificate Number : R1-CEP 2010-328 - Rev 03
Status : Valid
Issue Date : 2023-02-17
Type : Chemical
Substance Number : 2416
Pramipexole Dihydrochloride Monohydrate
Certificate Number : R1-CEP 2011-050 - Rev 01
Status : Valid
Issue Date : 2020-08-18
Type : Chemical
Substance Number : 2416
Pramipexole Dihydrochloride Monohydrate
Certificate Number : R1-CEP 2010-375 - Rev 00
Status : Valid
Issue Date : 2018-05-30
Type : Chemical
Substance Number : 2416
Pramipexole Dihydrochloride Monohydrate
Certificate Number : CEP 2011-038 - Rev 05
Status : Valid
Issue Date : 2024-07-30
Type : Chemical
Substance Number : 2416
Pramipexole Dihydrochloride Monohydrate
Certificate Number : CEP 2012-193 - Rev 01
Status : Valid
Issue Date : 2024-11-12
Type : Chemical
Substance Number : 2416
A Pramipexole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pramipexole, including repackagers and relabelers. The FDA regulates Pramipexole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pramipexole 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 Pramipexole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pramipexole supplier is an individual or a company that provides Pramipexole active pharmaceutical ingredient (API) or Pramipexole finished formulations upon request. The Pramipexole suppliers may include Pramipexole API manufacturers, exporters, distributors and traders.
click here to find a list of Pramipexole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pramipexole CEP of the European Pharmacopoeia monograph is often referred to as a Pramipexole Certificate of Suitability (COS). The purpose of a Pramipexole CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pramipexole EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pramipexole to their clients by showing that a Pramipexole CEP has been issued for it. The manufacturer submits a Pramipexole CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pramipexole CEP holder for the record. Additionally, the data presented in the Pramipexole CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pramipexole DMF.
A Pramipexole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pramipexole CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Pramipexole suppliers with CEP (COS) on PharmaCompass.
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