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List of Certificates of Suitability (CEPs) for Pramipexole Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 PIRAMAL PHARMA LIMITED Digwal Village IN (1)

02 CURIA SPAIN S.A.U. Boecillo ES (1)

03 ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN (1)

04 APITORIA PHARMA PRIVATE LIMITED Hyderabad IN (1)

05 APOTEX PHARMACHEM INDIA PVT. LTD Bangalore IN (1)

06 Amino Chemicals LTD. Marsa MT (1)

07 Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim Am Rhein DE (2)

08 CHR. OLESEN SYNTHESIS A/S Hvidovre DK (1)

09 CIPLA LIMITED Mumbai IN (1)

10 Erregierre S.p.A. San Paolo D'Argon IT (1)

11 HETERO DRUGS LIMITED Hyderabad IN (1)

12 MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN (1)

13 MYLAN LABORATORIES LIMITED Hyderabad IN (1)

14 OLON S.P.A. Rodano IT (1)

15 SYNTHON BV Nijmegen NL (1)

16 Unichem Laboratories Limited Mumbai IN (1)

17 Wockhardt Limited Mumbai IN (1)

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01 Pramipexole dihydrochloride monohydrate (17)

02 Pramipexole dihydrochloride monohydrate, Milled (1)

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01 Canada (1)

02 Denmark (1)

03 Germany (2)

04 India (7)

05 Italy (2)

06 Malta (1)

07 Netherlands (1)

08 U.S.A (3)

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01 Valid (16)

02 Withdrawn by Holder (2)

URL Supplier Web Content
R1-CEP 2014-313 - Rev 01
Valid
Chemical
2022-01-07
2416
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R1-CEP 2010-354 - Rev 01
Valid
Chemical
2021-08-24
2416
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R1-CEP 2011-190 - Rev 00
Valid
Chemical
2018-04-20
2416
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R1-CEP 2011-112 - Rev 00
Valid
Chemical
2018-02-07
2416
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CEP 2009-292 - Rev 03
Valid
Chemical
2023-11-16
2416
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R1-CEP 2011-171 - Rev 00
Valid
Chemical
2019-01-24
2416
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R1-CEP 2011-047 - Rev 02
Valid
Chemical
2021-08-16
2416
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R1-CEP 2010-364 - Rev 00
Valid
Chemical
2017-03-06
2416
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R1-CEP 2010-375 - Rev 00
Valid
Chemical
2018-05-30
2416
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R1-CEP 2012-193 - Rev 00
Valid
Chemical
2019-01-11
2416
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Looking for 191217-81-9 / Pramipexole API manufacturers, exporters & distributors?

Pramipexole manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Pramipexole API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Pramipexole manufacturer or Pramipexole supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pramipexole manufacturer or Pramipexole supplier.

PharmaCompass also assists you with knowing the Pramipexole API Price utilized in the formulation of products. Pramipexole API Price is not always fixed or binding as the Pramipexole Price is obtained through a variety of data sources. The Pramipexole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Pramipexole

Synonyms

191217-81-9, Mirapex, (s)-n6-propyl-4,5,6,7-tetrahydrobenzo[d]thiazole-2,6-diamine dihydrochloride hydrate, Pramipexole 2hcl monohydrate, Pramipexole hydrochloride, Sifrol

Cas Number

191217-81-9

Unique Ingredient Identifier (UNII)

3D867NP06J

About Pramipexole

A benzothiazole derivative and dopamine agonist with antioxidant properties that is used in the treatment of PARKINSON DISEASE and RESTLESS LEGS SYNDROME.

Pramipexole Manufacturers

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.

Pramipexole Suppliers

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.

Pramipexole CEP

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.

Pramipexole Manufacturers | Traders | Suppliers

Pramipexole Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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