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

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01 Aspen Oss B.V. (1)

02 MEDICHEM S.A. (1)

03 Neuland Laboratories Limited (3)

04 Neuland Laboratories Ltd. (2)

05 Aurobindo Pharma Limited (Unit-I) (3)

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01 Hiple Co., Ltd. (1)

02 Hyundai Pharmaceutical Co., Ltd. (1)

03 Leesung International Co., Ltd. (1)

04 Masung LS Co., Ltd. (1)

05 Medi Poem Co., Ltd. (1)

06 Samil Pharmaceutical Co., Ltd. (1)

07 Seongui Bio Co., Ltd. (1)

08 Sinex Co., Ltd. (2)

09 Youngjin Pharmaceutical Co., Ltd. (1)

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01 Mirtazapine (10)

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01 India (8)

02 Netherlands (1)

03 Spain (1)

Sinex Co., Ltd.
2022-01-12
20220112-209-J-1207
Aspen Oss B.V.
Netherlands
Veersemeer 4, 5347 JN Oss...
Sinex Co., Ltd.
2022-02-04
20220204-209-J-1227
MEDICHEM S.A.
Spain
Pirineus street, 127, Pol...
Medi Poem Co., Ltd.
2024-01-12
20201022-209-J-571(3)
Neuland Laboratories Limi...
India
Unit-I, Sy. No. 347,473,4...
Leesung International Co., Ltd.
2020-10-22
20201022-209-J-571
Neuland Laboratories Limi...
India
Unit-I, Sy. No. 347,473,4...
Youngjin Pharmaceutical Co., Ltd.
2021-04-16
20201022-209-J-571(1)
Neuland Laboratories Ltd.
India
Unit-I, Sy. No: 347, 473,...
Samil Pharmaceutical Co., Ltd.
2021-01-13
20210113-209-J-520
Neuland Laboratories Ltd.
India
Unit-I, Sy. No: 347, 473,...
Hiple Co., Ltd.
2021-06-16
20201022-209-J-571(2)
Neuland Laboratories Limi...
India
Unit-I, Sy. No. 347,473,4...
URL Supplier Web Content
Masung LS Co., Ltd.
2020-07-09
20190405-209-J-202(2)
Aurobindo Pharma Limited ...
India
Sy. No. 379, 385, 386, 38...
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Seongui Bio Co., Ltd.
2019-04-05
20190405-209-J-202
Aurobindo Pharma Limited ...
India
Survey No. 385, 386, 388 ...
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Hyundai Pharmaceutical Co., Ltd.
2020-05-19
20190405-209-J-202(1)
Aurobindo Pharma Limited ...
India
Sy. No. 379, 385, 386, 38...
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Looking for 61337-67-5 / Mirtazapine API manufacturers, exporters & distributors?

Mirtazapine manufacturers, exporters & distributors 1

84

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 KDMF

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

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

After submitting a Mirtazapine 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 Mirtazapine API can apply through the Korea Drug Master File (KDMF).

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

Mirtazapine Manufacturers | Traders | Suppliers

Mirtazapine Manufacturers, Traders, Suppliers 1
40

We have 4 companies offering Mirtazapine

Get in contact with the supplier of your choice:

  1. Aspen API
  2. Medichem S.A
  3. Neuland Laboratories
  4. Aurobindo Pharma Limited
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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