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

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01 Interquim SA (1)

02 Seqens (1)

03 Neuland Laboratories (1)

04 Olon S.p.A (2)

05 Sichuan Qingmu Pharmaceutical (1)

06 Solara Active Pharma Sciences (1)

07 Teva API (1)

08 Viatris (1)

09 Blank (1)

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01 N-0923 (1)

02 ROTIGOTINE (5)

03 ROTIGOTINE POLYMORPH II (1)

04 ROTIGOTINE USP (3)

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01 China (1)

02 France (1)

03 India (2)

04 Israel (1)

05 Italy (2)

06 Spain (1)

07 U.S.A (1)

08 Blank (1)

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01 Active (8)

02 Inactive (2)

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01 Complete (6)

02 Blank (4)

32684
Active
2018-03-31
Complete
2018-11-05
2018-09-07
II
URL Supplier Web Content
27554
Active
2013-09-13
Complete
2014-03-31
2013-10-23
II
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URL Supplier Web Content
25863
Inactive
2012-03-07
N/A
II
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URL Supplier Web Content
38363
Active
2023-05-31
N/A
II
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URL Supplier Web Content
37811
Active
2022-12-30
N/A
II
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URL Supplier Web Content
29468
Active
2015-06-30
Complete
2015-09-16
2015-06-22
II
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URL Supplier Web Content
27370
Active
2013-08-30
Complete
2013-11-27
2013-08-20
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DISCOVERY THERAPEUTICS INC

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Digital Content Digital Content
URL Supplier Web Content
8232
Inactive
1989-09-29
N/A
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Looking for 99755-59-6 / Rotigotine API manufacturers, exporters & distributors?

Rotigotine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Rotigotine 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 Rotigotine manufacturer or Rotigotine supplier for your needs.

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

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

API | Excipient name

Rotigotine

Synonyms

99755-59-6, Neupro, Leganto, Spm 962, (s)-6-(propyl(2-(thiophen-2-yl)ethyl)amino)-5,6,7,8-tetrahydronaphthalen-1-ol, Spm-962

Cas Number

99755-59-6

Unique Ingredient Identifier (UNII)

87T4T8BO2E

About Rotigotine

Rotigotine (Neupro) is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS) in Europe and the United States. It is formulated as a once-daily transdermal patch which provides a slow and constant supply of the drug over the course of 24 hours. Like other dopamine agonists, rotigotine has been shown to possess antidepressant effects and may be useful in the treatment of depression as well. Rotigotine was developed by Aderis Pharmaceuticals. In 1998 Aderis licensed worldwide development and commercialization rights to Schwarz Pharma of Germany. It was approved by the European Medicines Agency in 2006 and by the FDA in 2007. However, all Neupro patches in the United States and some of Europe were recalled in 2008 due to delivery mechanism issues. Rotigotine has been authorized as a treatment for RLS since August 2008.

Rotigotine Manufacturers

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

Rotigotine Suppliers

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

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

Rotigotine USDMF

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

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

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

Rotigotine Manufacturers | Traders | Suppliers

Rotigotine Manufacturers, Traders, Suppliers 1
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We have 8 companies offering Rotigotine

Get in contact with the supplier of your choice:

  1. Interquim SA
  2. Seqens
  3. Neuland Laboratories
  4. Olon S.p.A
  5. Sichuan Qingmu Pharmaceutical
  6. Solara Active Pharma Sciences
  7. Teva API
  8. Viatris
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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