Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
01 1Interquim SA
02 1Seqens
03 1Neuland Laboratories
04 1TAPI Technology & API Services
05 2Olon S.p.A
06 1Sichuan Qingmu Pharmaceutical
07 1Solara Active Pharma Sciences
08 1Viatris
09 1Blank
Interquim 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 :
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-03
Pay. Date : 2013-01-28
DMF Number : 26236
Submission : 2012-07-12
Status :
Type : II
Neuland 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 :
Type : II
TAPI, 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 :
Type : II
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.
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.
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.
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