Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
01 1Nuray Chemicals Private Limited
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1TAPI Technology & API Services
04 1Aurobindo Pharma Limited
05 1Enaltec Labs Private Limited
06 1MSN Laboratories
07 1Zhejiang Ausun Pharmaceutical
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-27
Pay. Date : 2018-06-04
DMF Number : 32444
Submission : 2018-06-06
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-12
Pay. Date : 2020-09-24
DMF Number : 34414
Submission : 2019-12-31
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 : 2018-03-27
Pay. Date : 2018-03-12
DMF Number : 22882
Submission : 2009-06-22
Status :
Type : II
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PharmaCompass offers a list of Ramelteon 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 Ramelteon manufacturer or Ramelteon supplier for your needs.
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PharmaCompass also assists you with knowing the Ramelteon API Price utilized in the formulation of products. Ramelteon API Price is not always fixed or binding as the Ramelteon Price is obtained through a variety of data sources. The Ramelteon Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ramelteon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ramelteon, including repackagers and relabelers. The FDA regulates Ramelteon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ramelteon API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Ramelteon supplier is an individual or a company that provides Ramelteon active pharmaceutical ingredient (API) or Ramelteon finished formulations upon request. The Ramelteon suppliers may include Ramelteon API manufacturers, exporters, distributors and traders.
click here to find a list of Ramelteon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ramelteon DMF (Drug Master File) is a document detailing the whole manufacturing process of Ramelteon active pharmaceutical ingredient (API) in detail. Different forms of Ramelteon DMFs exist exist since differing nations have different regulations, such as Ramelteon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ramelteon DMF submitted to regulatory agencies in the US is known as a USDMF. Ramelteon USDMF includes data on Ramelteon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ramelteon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ramelteon suppliers with USDMF on PharmaCompass.
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