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List of all Manufacturers, Suppliers & Exporters of Rotigotine API listed on PharmaCompass with details of regulatory filings

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01 Interquim SA (1)

02 Seqens (1)

03 Neuland Laboratories (1)

04 LGM Pharma (1)

05 Aspire Lifesciences Pvt Ltd (1)

06 DEAFARMA (1)

07 Guangzhou Tosun Pharmaceutical (1)

08 Hangzhou Longshine Bio-Tech (1)

09 Haoyuan Chemexpress Co.Ltd (1)

10 Lusochimica SPA (1)

11 Maithri Drugs (1)

12 Olon S.p.A (2)

13 Shodhana Laboratories Pvt. Ltd (1)

14 Sichuan Qingmu Pharmaceutical (1)

15 Solara Active Pharma Sciences (1)

16 Teva API (1)

17 Teva Pharmaceutical Industries (1)

18 Viatris (1)

19 Zhejiang Ausun Pharmaceutical (1)

20 Blank (1)

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01 China (5)

02 France (1)

03 India (5)

04 Israel (2)

05 Italy (4)

06 Spain (1)

07 U.S.A (2)

08 Blank (1)

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01 Active (8)

02 Inactive (2)

03 Blank (11)

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01 Valid (4)

02 Blank (17)

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01 Blank (21)

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01 WC-0036 (1)

02 WC-0157 (1)

03 Blank (19)

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
26481
R0-CEP 2019-302 - Rev 00
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ROTIGOTINE
Rotigotine
Issue/Submission Date
2012-09-26
2021-05-28
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
26236
CEP 2021-291 - Rev 01
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ROTIGOTINE
Rotigotine
Issue/Submission Date
2012-07-12
2023-09-18
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
32684
R0-CEP 2020-010 - Rev 03
Indian CDSCO WC-0036
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
ROTIGOTINE USP
Rotigotine
Rotigotine IH
Issue/Submission Date
2018-03-31
2023-03-29
2022-07-28
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
29468
Status
Active
Fees Paid
Reviewed
 
Filing Details
ROTIGOTINE
Issue/Submission Date
2015-06-30
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Application Number
27370
Indian CDSCO WC-0157
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-02
Filing Details
ROTIGOTINE USP
Rotigotine IH
Issue/Submission Date
2013-08-30
2019-10-11
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USDMF

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Application Number
27554
Status
Active
Fees Paid
Reviewed
 
Filing Details
ROTIGOTINE POLYMORPH II
Issue/Submission Date
2013-09-13
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
38363
R0-CEP 2022-035 - Rev 00
Status
Active
Fees Unpaid
N/A
Valid
 
Filing Details
ROTIGOTINE
Rotigotine
Issue/Submission Date
2023-05-31
2023-08-25
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USDMF

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Written Confirmation

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Application Number
37811
Status
Active
Fees Paid
N/A
 
Filing Details
ROTIGOTINE USP
Issue/Submission Date
2022-12-30
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USDMF

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Application Number
25863
Status
Inactive
Fees Paid
N/A
 
Filing Details
ROTIGOTINE
Issue/Submission Date
2012-03-07
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USDMF

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Application Number
8232
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
N-0923
Issue/Submission Date
1989-09-29
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Looking for 99755-59-6 / Rotigotine API manufacturers, exporters & distributors?

Rotigotine manufacturers, exporters & distributors 1

12

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.

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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