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Aarti Pharmalabs Mirabegron Aarti Pharmalabs Mirabegron

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List of Drug Master Files (DMF) of Myrbetriq Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Neuland Laboratories (1)

02 Metrochem API Private Limited (1)

03 Dr. Reddy's Laboratories (2)

04 Minakem (formerly Delmar Chemicals) (1)

05 Megafine Pharma (P) Limited (1)

06 Hubei Gedian Humanwell Pharmaceutical (1)

07 Amoli Organics (1)

08 Aurobindo Pharma Limited (1)

09 Biocon (1)

10 CHEMO SMS ENTERPRISE SL (1)

11 Cipla (1)

12 Glenmark Life Sciences (1)

13 Hangzhou Huadong Medicine Group Kangrun Pharmaceutical (1)

14 Hetero Drugs (1)

15 Jiangxi Synergy Pharmaceutical (1)

16 Jubilant Generics (1)

17 Lupin Ltd (1)

18 MSN Laboratories (2)

19 Micro Labs Limited (1)

20 Optimus Pharma (2)

21 Piramal Pharma Solutions (1)

22 Solara Active Pharma Sciences (1)

23 Synthon Pharmaceuticals (1)

24 Unichem Laboratories Limited (1)

25 Vasudha Pharma Chem (1)

26 Viwit Pharmaceuticals Limited (1)

27 ZCL Chemicals Limited (1)

28 Zhejiang Huahai Pharmaceutical (1)

29 Zydus Lifesciences (1)

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01 (1R)-2-[(2-(4-NITROPHENYL) ETHYL] AMINO] -1- PHENYL ETHANOL. HCL (MIRABEGRON INTERMEDIATE) (1)

02 (R) -ALPHA-[[[2-(4-NITRO-PHENYL)-ETHYL]AMINO]METHYL]BENZENE METHANOL(MIRABEGRON INTERMEDIATE) (1)

03 MIRABEGRON (23)

04 MIRABEGRON (FORM-B) (1)

05 MIRABEGRON (a-FORM) (1)

06 MIRABEGRON DRUG SUBSTANCE (1)

07 MIRABEGRON IH (1)

08 MIRABEGRON [FORM - AMORPHOUS] (1)

09 MIRABEGRON [PRODUCT CODE: AEB] (1)

10 MIRABEGRON [ROUTE CODE "MG"] (1)

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01 Canada (1)

02 China (5)

03 India (23)

04 Netherlands (1)

05 U.S.A (1)

06 Blank (1)

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01 Active (32)

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01 Complete (21)

02 Blank (11)

32929
Active
2018-09-14
Complete
2020-12-03
2018-07-09
II
Minakem Delmar

2024 ACI Convention

Not Confirmed

envelop Contact Supplier
29773
Active
2015-09-25
Complete
2016-02-05
2015-09-30
II
Megafine Pharma CB

2024 ACI Convention

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
29734
Active
2015-09-28
Complete
2016-04-27
2015-09-28
II
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URL Supplier Web Content
28071
Active
2014-03-20
Complete
2015-12-17
2015-09-29
II
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URL Supplier Web Content
28420
Active
2014-06-25
N/A
II
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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.

Myrbetriq Manufacturers

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

Myrbetriq Suppliers

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

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

Myrbetriq USDMF

A Myrbetriq DMF (Drug Master File) is a document detailing the whole manufacturing process of Myrbetriq active pharmaceutical ingredient (API) in detail. Different forms of Myrbetriq DMFs exist exist since differing nations have different regulations, such as Myrbetriq USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Myrbetriq DMF submitted to regulatory agencies in the US is known as a USDMF. Myrbetriq USDMF includes data on Myrbetriq's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Myrbetriq USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Myrbetriq suppliers with USDMF 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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