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

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01 Nuray Chemicals Private Limited (1)

02 Biophore India Pharmaceuticals Pvt Ltd (1)

03 Aurobindo Pharma Limited (1)

04 Enaltec Labs Private Limited (1)

05 MSN Laboratories (1)

06 Teva API (1)

07 Zhejiang Ausun Pharmaceutical (1)

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01 RAMELTEON (7)

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01 China (1)

02 India (5)

03 Israel (1)

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01 Active (7)

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01 Complete (7)

32444
Active
2018-06-06
Complete
2018-07-27
2018-06-04
II
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34899
Active
2020-05-30
Complete
2020-06-16
2020-05-28
II
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33601
Active
2019-05-14
Complete
2020-11-12
2020-09-29
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31506
Active
2017-03-30
Complete
2017-09-15
2017-08-09
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22882
Active
2009-06-22
Complete
2018-03-27
2018-03-12
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33719
Active
2019-08-31
Complete
2019-10-22
2019-08-16
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Looking for 196597-26-9 / Ramelteon API manufacturers, exporters & distributors?

Ramelteon manufacturers, exporters & distributors 1

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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.

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

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.

API | Excipient name

Ramelteon

Synonyms

196597-26-9, Rozerem, Tak-375, (s)-n-[2-(1,6,7,8-tetrahydro-2h-indeno-[5,4-b]furan-8-yl)ethyl]propionamide, (s)-n-(2-(1,6,7,8-tetrahydro-2h-indeno[5,4-b]furan-8-yl)ethyl)propionamide, Tak375

Cas Number

196597-26-9

Unique Ingredient Identifier (UNII)

901AS54I69

About Ramelteon

Ramelteon is a synthetic melatonin analogue with hypnotic and circadian rhythm-modulating activities. Ramelteon binds to and activates melatonin receptors 1 and 2 in the suprachiasmatic nucleus (SCN) of the brain, thereby promoting the onset of sleep. Unlike the nonbenzodiazepine sedative hypnotics zolpidem and zaleplon, this agent does not activate GABA receptors and, so, produces no GABA receptor-mediated anxiolytic, myorelaxant, and amnesic effects.

Ramelteon Manufacturers

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.

click here to find a list of Ramelteon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Ramelteon Suppliers

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.

Ramelteon USDMF

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.

Ramelteon Manufacturers | Traders | Suppliers

Ramelteon Manufacturers, Traders, Suppliers 1
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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