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List of Drug Master Files (KDMF) for Agomelatine Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 MSN Pharmachem Private Limited (1)

02 ORIL Industry (1)

03 Symed Labs Limited (2)

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01 Aging Life Science Co., Ltd. (1)

02 Hiple Co., Ltd. (1)

03 Pharmapia Co., Ltd. (1)

04 Servier Korea Co., Ltd. (1)

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01 agomelatine (4)

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01 France (1)

02 India (1)

03 Malaysia (2)

URL Supplier Web Content
Aging Life Science Co., Ltd.
2023-10-05
Number 434-59-ND
MSN Pharmachem Private Li...
India
Plot No. 212/A, B, C, D, ...
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Servier Korea Co., Ltd.
2010-05-27
Number 3056-1-ND
ORIL Industry
France
13, rue Auguste Desgeneta...
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Hiple Co., Ltd.
2016-12-02
Number 50-1-ND
Symed Labs Limited
India
Plot No.25/B, Phase-III, ...
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Pharmapia Co., Ltd.
2021-04-16
Number 50-1-ND(1)
Symed Labs Limited
India
Plot No.25/B, Phase-III, ...
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Looking for 138112-76-2 / Agomelatine API manufacturers, exporters & distributors?

Agomelatine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Agomelatine 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 Agomelatine manufacturer or Agomelatine supplier for your needs.

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

PharmaCompass also assists you with knowing the Agomelatine API Price utilized in the formulation of products. Agomelatine API Price is not always fixed or binding as the Agomelatine Price is obtained through a variety of data sources. The Agomelatine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Agomelatine

Synonyms

138112-76-2, Thymanax, Valdoxan, N-[2-(7-methoxynaphthalen-1-yl)ethyl]acetamide, N-(2-(7-methoxynaphthalen-1-yl)ethyl)acetamide, S20098

Cas Number

138112-76-2

Unique Ingredient Identifier (UNII)

137R1N49AD

About Agomelatine

Agomelatine is structurally closely related to melatonin. Agomelatine is a potent agonist at melatonin receptors and an antagonist at serotonin-2C (5-HT2C) receptors, tested in an animal model of depression. Agomelatine was developed in Europe by Servier Laboratories Ltd. and submitted to the European Medicines Agency (EMA) in 2005. The Committee for Medical Products for Human Use (CHMP) recommended refusal of marketing authorization on 27 July 2006. The major concern was that efficacy had not been sufficiently shown. In 2006 Servier sold the rights to develop Agomelatine in the US to Novartis. The development for the US market was discontinued in October 2011. It is currently sold in Australia under the Valdoxan trade name.

Agomelatine Manufacturers

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

Agomelatine Suppliers

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

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

Agomelatine KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Agomelatine Drug Master File in Korea (Agomelatine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Agomelatine. The MFDS reviews the Agomelatine KDMF as part of the drug registration process and uses the information provided in the Agomelatine KDMF to evaluate the safety and efficacy of the drug.

After submitting a Agomelatine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Agomelatine API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Agomelatine suppliers with KDMF on PharmaCompass.

Agomelatine Manufacturers | Traders | Suppliers

Agomelatine Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Agomelatine

Get in contact with the supplier of your choice:

  1. MSN Laboratories
  2. Servier
  3. Symbiotica Specialty Ingredients
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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