Aarti Pharmalabs Mirabegron Aarti Pharmalabs Mirabegron

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List of Korea Drug Master Files (KDMF) for Mirabegron Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Flag India
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Chong Kun Dang Co., Ltd.
2020-08-27
Number 574-10-ND(2)
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
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Hanmi Pharmaceutical Co., Ltd.
2020-05-28
Number 574-10-ND(1)
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
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Farmirae Co., Ltd.
2018-02-08
Number 574-10-ND
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
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Korea Astellas Pharmaceutical Co., Ltd.
2013-12-31
Number 3778-4-ND
Astellas Pharma Inc. Taka...
Japan
160-2, Akahama, Takahagi-...
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Korea Astellas Pharmaceutical Co., Ltd.
2016-07-27
Number 3778-7-ND
Astellas Ireland Co., Ltd...
Ireland
Damastown Road, Damastown...
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Bahnsen Co., Ltd.
2020-02-20
Number 720-1-ND
Biocon Limited
India
Plot No. 2-5, Phase IV, B...
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Pharma Solution Co., Ltd.
2018-06-01
Number 55-6-ND(A)
Glenmark Life Sciences Li...
India
Plot No.Z-103/Ⅰ, DAHEJ ...
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Mpeak Korea Co., Ltd.
2017-10-24
Number 55-6-ND
Glenmark Life Sciences Li...
India
Plot No.Z-103/Ⅰ, DAHEJ ...
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Aging Life Science Co., Ltd.
2018-03-14
Number 55-6-ND(1)
Glenmark Life Sciences Li...
India
Plot No.Z-103/Ⅰ, DAHEJ ...
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Hanmi Pharmaceutical Co., Ltd.
2019-06-27
Number 55-6-ND(3)
Glenmark Life Sciences Li...
India
Plot No.Z-103/Ⅰ, DAHEJ ...
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SG Biochem Co., Ltd.
2021-08-28
Number 55-6-ND(4)
Glenmark Life Sciences Lt...
India
Plot No.Z-103/Ⅰ, DAHEJ ...
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Hanseochem Co., Ltd.
2020-09-25
2295-13-ND
Hanseochem Co., Ltd.
South Korea
41 Poseunggongdan-ro, Pos...
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Inist ST Co., Ltd.
2022-09-22
2220-12-ND
Inist ST Co., Ltd.
South Korea
500 Sinnae-ro, Geumwang-e...
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Korea Biochem Pharmaceutical Co., Ltd.
2020-07-14
2152-8-ND
Korea Biochem Pharmaceuti...
South Korea
204 Sandan-gil, Jeonui-my...
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Kyungbo Pharmaceutical Co., Ltd.
2021-11-15
1673-47-ND
Kyungbo Pharmaceutical Co...
South Korea
174, Silok-ro, Asan-si, C...
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Kyungbo Pharmaceutical Co., Ltd.
2022-10-13
1673-52-ND
Kyungbo Pharmaceutical Co...
South Korea
174, Silok-ro, Asan-si, C...
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Kyungdong Pharmaceutical Co., Ltd.
2019-12-23
1574-7-ND
Kyungdong Pharmaceutical ...
South Korea
15 Balangongdan-ro 2-gil,...
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UNUST Co., Ltd.
2018-10-28
Number 497-1-ND
Lupine Limited
India
Block No.21, Dabhasa, Tal...
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Masung LS Co., Ltd.
2021-06-01
Number 497-1-ND(1)
Lupine Limited
India
Block No.21, Dabhasa, Tal...
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Pharmapia Co., Ltd.
2020-07-21
Wed258-11-ND
MSN Laboratories Private ...
India
Sy. No. 317, 320, 321, 32...
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Dasan Pharmaceutical Co., Ltd.
2021-01-15
2243-11-ND
SPC Co., Ltd. @Dasan Phar...
South Korea
386 Pyeongtaekhangman-gil...
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Korea Astellas Pharmaceutical Co., Ltd.
2023-01-27
Number 132-9-ND
Sumitomo Chemical Company...
Japan
6-4-1, Kojimatanokuchi, K...
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Otran Farm Korea Co., Ltd.
2023-01-19
Number 695-16-ND
Viwit Pharmaceutical Co.,...
China
88 Weizhi Road, Tengzhou ...
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Aging Life Science Co., Ltd.
2020-09-29
Number 434-22-ND
ZCL Chemicals Limited
India
Plot No. 3102/B GIDC, Ind...
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SG Biochem Co., Ltd.
2021-07-13
Number 434-22-ND(1)
ZCL Chemicals Limited
India
Plot No. 3102/B GIDC, Ind...
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Kookjeon Pharmaceutical Co., Ltd.
2023-11-02
Number 173-46-ND
Zhejiang Huahai Pharmaceu...
China
Chuannan Duqiao, Linhai, ...
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  • TABLET, EXTENDED RELEASE;ORAL - 25MG
  • TABLET, EXTENDED RELEASE;ORAL - 50MG

Looking for 223673-61-8 / Mirabegron API manufacturers, exporters & distributors?

Mirabegron manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Mirabegron

Synonyms

223673-61-8, Myrbetriq, Betanis, Betmiga, Ym178, Mirabegron (ym178)

Cas Number

223673-61-8

Unique Ingredient Identifier (UNII)

MVR3JL3B2V

About Mirabegron

Mirabegron is an orally bioavailable agonist of the human beta-3 adrenergic receptor (ADRB3), with muscle relaxing, neuroprotective and potential antineoplastic activities. Upon oral administration, mirabegron binds to and activates ADRB3, which leads to smooth muscle relaxation. Mirabegron also restores sympathetic stimulation in mesenchymal stem cell (MSC) niches, inhibits JAK2-mutated hematopoietic stem cell (HSC) expansion and blocks the progression of myeloproliferative neoplasms (MPNs). Lack of sympathetic stimulation of the MSC and HSC niche is associated with the development of MPNs.

Mirabegron Manufacturers

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

Mirabegron Suppliers

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

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

Mirabegron KDMF

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

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

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

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

Mirabegron Manufacturers | Traders | Suppliers

Mirabegron 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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