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List of all Manufacturers, Suppliers & Exporters of Mirtazapine API listed on PharmaCompass with details of regulatory filings

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01 LGM Pharma (1)

02 Aspen API (1)

03 Sun Pharmaceutical Industries Limited (1)

04 Deccan Nutraceuticals Pvt. Ltd (1)

05 HRV Global Life Sciences (1)

06 Medichem S.A (1)

07 Megafine Pharma (P) Limited (2)

08 Neuland Laboratories (3)

09 Teva API (1)

10 Angelini Pharma (1)

11 Assia Chemical Industries Ltd (1)

12 Aurobindo Pharma Limited (1)

13 Aurore Life Sciences (1)

14 Estechpharma (1)

15 Fujifilm Diosynth Biotechnologies (1)

16 Hetero Drugs (1)

17 KOLON Life Science, Inc (1)

18 Maithri Drugs (2)

19 Micro Labs Limited (1)

20 Nifty Labs (1)

21 Ramdev Chemicals Pvt Ltd (1)

22 Sato Yakuhin Kogyo Co., Ltd (1)

23 Sms Lifesciences (1)

24 Sumitomo Chemical (1)

25 Suzhou Hengyi Pharmaceutical (1)

26 Syn-Tech Chem. & Pharm (1)

27 Teva Pharmaceutical Industries (1)

28 Viatris (3)

29 Zhejiang Liaoyuan Pharmaceutical Co LTD (2)

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01 China (3)

02 India (17)

03 Israel (3)

04 Italy (1)

05 Japan (2)

06 Netherlands (1)

07 South Korea (2)

08 Spain (1)

09 Taiwan (1)

10 U.S.A (4)

11 United Kingdom (1)

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01 Active (15)

02 Inactive (5)

03 Blank (16)

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01 Valid (14)

02 Blank (22)

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01 219MF10237 (1)

02 229MF10101 (1)

03 229MF10107 (1)

04 229MF10115 (1)

05 229MF10154 (1)

06 229MF10155 (1)

07 229MF10163 (1)

08 230MF10113 (1)

09 301MF10005 (1)

10 Blank (27)

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01 WC-0016A2 (2)

02 WC-0036 (1)

03 WC-0037 (1)

04 WC-0040A3 (1)

05 WC-0087-(Annexure-1) (1)

06 WC-0119 (1)

07 WC-0120 (1)

08 WC-0168 (1)

09 WC-0407 (1)

10 Blank (26)

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
10457
R1-CEP 2010-016 - Rev 03
219MF10237
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
MIRTAZAPINE
Mirtazapine
Mirtazapine at Kloosterstraat 6, 53...
Issue/Submission Date
1993-08-30
2022-12-15
2007-07-17
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
Status
 
Filing Details
Issue/Submission Date
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
Status
 
Filing Details
Issue/Submission Date
HRV Global Life Sciences Company Banner

EMWA 2024

Not Confirmed

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
15749
R1-CEP 2007-178 - Rev 00
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
MIRTAZAPINE
Mirtazapine
Issue/Submission Date
2001-12-05
2013-09-05
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
20570
R1-CEP 2008-214 - Rev 03
Indian CDSCO WC-0087-(Annexure-1)
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-21
Filing Details
MIRTAZAPINE ANHYDROUS USP (NON-STER...
Mirtazapine, Hemihydrate
Mirtazapine IP/USP/EP / Mirtazapine...
Issue/Submission Date
2007-05-28
2023-01-25
2022-07-27
Megafine Pharma CB

EMWA 2024

Not Confirmed

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USDMF

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CEP/COS

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Japanese DMF

Found JDMF

Written Confirmation

Found WC

Application Number
16007
R1-CEP 2008-243 - Rev 05
301MF10005
Indian CDSCO WC-0036
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-16
Filing Details
MIRTAZAPINE
Mirtazapine
Mirtazapine at 11th Floor (5th Offi...
Mirtazapine (USP/Ph.Eur)
Issue/Submission Date
2002-06-11
2022-12-19
2019-05-15
2022-07-28
URL Supplier Web Content
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Application Number
16113
R1-CEP 2010-293 - Rev 00
Indian CDSCO WC-0168
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-07-14
Filing Details
MIRTAZAPINE USP [HEMIHYDRATE]
Mirtazapine
Mirtazapine (EP/BP/USP)
Issue/Submission Date
2002-08-22
2018-04-05
2019-07-15
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
23003
Status
Active
Fees Paid
Reviewed
 
Filing Details
MIRTAZAPINE HEMIHYDRATE USP (NON ST...
Issue/Submission Date
2009-07-30
Megafine Pharma CB

EMWA 2024

Not Confirmed

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USDMF

Found USDMF

CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
24022
Indian CDSCO WC-0037
Status
Active
Fees Paid
N/A
 
Valid
2025-06-16
Filing Details
MIRTAZAPINE, USP (ANHYDROUS)
Mirtazapine USP/Ph.Eur
Issue/Submission Date
2010-08-04
2022-06-08

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.

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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