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01 1Interquim SA

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03 1Neuland Laboratories

04 1TAPI Technology & API Services

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06 1Sichuan Qingmu Pharmaceutical

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08 1Viatris

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PharmaCompass

01

BioAsia
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothInterquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

GDUFA

DMF Review : Complete

Rev. Date : 2021-10-14

Pay. Date : 2021-09-07

DMF Number : 26481

Submission : 2012-09-26

Status : Active

Type : II

Interquim

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

GDUFA

DMF Review : Complete

Rev. Date : 2014-03-03

Pay. Date : 2013-01-28

DMF Number : 26236

Submission : 2012-07-12

Status : Active

Type : II

Seqens Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : Complete

Rev. Date : 2018-11-05

Pay. Date : 2018-09-07

DMF Number : 32684

Submission : 2018-03-31

Status : Active

Type : II

Neuland

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

GDUFA

DMF Review : Complete

Rev. Date : 2015-09-16

Pay. Date : 2015-06-22

DMF Number : 29468

Submission : 2015-06-30

Status : Active

Type : II

TAPI Company Banner

10

Discovery Therapeutics Inc

Country

USDMF

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BioAsia
Not Confirmed

10

Discovery Therapeutics Inc

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BioAsia
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 8232

Submission : 1989-09-29

Status : Inactive

Type : II

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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 Hydrochloride Manufacturers

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

Rotigotine Hydrochloride Suppliers

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

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

Rotigotine Hydrochloride USDMF

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

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

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

Rotigotine Hydrochloride Manufacturers | Traders | Suppliers

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

Get in contact with the supplier of your choice:

  1. Interquim SA
  2. Seqens
  3. Neuland Laboratories
  4. TAPI Technology & API Services
  5. Olon S.p.A
  6. Sichuan Qingmu Pharmaceutical
  7. Solara Active Pharma Sciences
  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.