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List of Drug Master Files (DMF) of Pramipexole Dihydrochloride Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Alembic Pharmaceuticals Limited (1)

02 Amino Chemicals (2)

03 Apotex Pharmachem (1)

04 Aurobindo Pharma Limited (1)

05 Boehringer Ingelheim GmbH (1)

06 Chr. Olesen Synthesis A.S (1)

07 Cipla (1)

08 Curia (1)

09 Erregierre SpA (1)

10 Hetero Drugs (1)

11 MSN Laboratories (1)

12 Macleods Pharmaceuticals Limited (1)

13 Olon S.p.A (1)

14 Orchid Pharma (1)

15 Par Pharmaceutical (1)

16 Perrigo API India Private Limited (1)

17 Piramal Pharma Solutions (1)

18 Sun Pharmaceutical Industries Limited (1)

19 Torrent Pharmaceuticals Limited (1)

20 Unichem Laboratories Limited (1)

21 Viatris (1)

22 Wockhardt (1)

23 Zydus Lifesciences (1)

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01 PRAMIPEXOL DIHYDROCHLORIDE (1)

02 PRAMIPEXOLE AS PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (1)

03 PRAMIPEXOLE BASE (2)

04 PRAMIPEXOLE DIHYDROCHLORIDE (2)

05 PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (5)

06 PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE PH EUR (1)

07 PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP (6)

08 PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP [ROUTE CODE PP] (1)

09 PRAMIPEXOLE DIHYDROCHLORIDE USP (3)

10 PRAMIPEXOLE DIHYDROCHLORIDE USP (MONOHYDRATE) (1)

11 PRAMIPEXOLE DIHYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE) (1)

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01 Canada (1)

02 Denmark (1)

03 Germany (1)

04 India (13)

05 Italy (2)

06 Malta (2)

07 U.S.A (4)

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01 Active (22)

02 Inactive (2)

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01 Complete (7)

02 Blank (17)

URL Supplier Web Content
18836
Active
2005-10-06
N/A
II
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18297
Active
2005-04-21
Complete
2019-04-12
2019-02-19
II
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21413
Active
2008-03-12
N/A
II
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18701
Active
2005-08-25
N/A
II
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21791
Active
2008-07-11
N/A
II
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19853
Active
2006-10-10
Complete
2014-06-05
2014-06-03
II
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21082
Active
2007-11-28
N/A
II
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21631
Active
2008-05-19
N/A
II
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21712
Active
2008-05-28
N/A
II
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20130
Active
2007-01-08
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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 Dihydrochloride Manufacturers

A Pramipexole Dihydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pramipexole Dihydrochloride, including repackagers and relabelers. The FDA regulates Pramipexole Dihydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pramipexole Dihydrochloride 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 Dihydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Pramipexole Dihydrochloride Suppliers

A Pramipexole Dihydrochloride supplier is an individual or a company that provides Pramipexole Dihydrochloride active pharmaceutical ingredient (API) or Pramipexole Dihydrochloride finished formulations upon request. The Pramipexole Dihydrochloride suppliers may include Pramipexole Dihydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Pramipexole Dihydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Pramipexole Dihydrochloride USDMF

A Pramipexole Dihydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Pramipexole Dihydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Pramipexole Dihydrochloride DMFs exist exist since differing nations have different regulations, such as Pramipexole Dihydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Pramipexole Dihydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Pramipexole Dihydrochloride USDMF includes data on Pramipexole Dihydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pramipexole Dihydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Pramipexole Dihydrochloride suppliers with USDMF on PharmaCompass.

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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