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List of Drug Master Files (JDMF) for Mirtazapine Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Aspen Oss B. V. (1)

02 Neuland Laboratories Limited. (1)

03 Assia Chemical Industries Ltd. (1)

04 Daiwa Pharmaceutical Co., Ltd. (1)

05 HETERO DRUGS LIMITED. (1)

06 KOLON LIFE SCIENCE, INC. (1)

07 Sumitomo Chemical Co., Ltd. (1)

08 Syn-Tech Chem. & Pharm. Co. , Ltd. (1)

09 Zhejiang Liaoyuan Pharmaceutical Co. , Ltd. (1)

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01 Mirtazapine (6)

02 Mirtazapine "Teva" (1)

03 Mirtazapine (production only) (1)

04 Mirtazapine [D] (1)

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01 China (1)

02 India (2)

03 Israel (1)

04 Japan (2)

05 Netherlands (1)

06 South Korea (1)

07 Taiwan (1)

219MF10237
Kloosterstraat 6, 5349 AB Oss, the ...
2020-01-31
2007-07-17
301MF10005
11th Floor (5th Office Level), Phoe...
2020-01-07
2019-05-15
URL Supplier Web Content
229MF10163
Neot-Hovav Eco-Industrial Park, Eme...
2018-05-11
2017-08-22
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230MF10113
7-2-A2, Hetero Corporate, Industria...
2018-08-22
2018-08-22
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229MF10154
110, MAGOKDONG-RO, GANGSEO-GU, SEOU...
2017-08-04
2017-08-04
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229MF10101
2-3-5 Shimookui, Toyama City, Toyam...
2018-05-11
2017-06-06
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229MF10107
2-27-1 Shinkawa, Chuo-ku, Tokyo
2020-07-22
2017-06-21
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229MF10115
No. 168 Kai-Yuan Rd. , Hsin-Ying Ta...
2017-06-30
2017-06-30
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229MF10155
Zhejiang Provincial Chemical and Me...
2018-05-08
2017-08-04
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Looking for 61337-67-5 / Mirtazapine API manufacturers, exporters & distributors?

Mirtazapine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Mirtazapine

Synonyms

85650-52-8, Remeron, 61337-67-5, 6-azamianserin, Zispin, Mepirzepine

Cas Number

61337-67-5

Unique Ingredient Identifier (UNII)

A051Q2099Q

About Mirtazapine

A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders.

Mirtazapine Manufacturers

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

Mirtazapine Suppliers

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

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

Mirtazapine JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Mirtazapine Drug Master File in Japan (Mirtazapine JDMF) empowers Mirtazapine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Mirtazapine JDMF during the approval evaluation for pharmaceutical products. At the time of Mirtazapine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Mirtazapine suppliers with JDMF on PharmaCompass.

Mirtazapine Manufacturers | Traders | Suppliers

Mirtazapine 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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