Synopsis
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JDMF
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
Neuland Laboratories- A dedicated 100% API provider.
CEP/COS 
NDC
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
EU-WC
NDC
KDMF
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
Minakem is manufacturing small molecules APIs including corticosteroids
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
EU-WC
NDC
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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USDMF
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38770
Submission : 2023-08-31
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-19
Pay. Date : 2015-03-04
DMF Number : 29064
Submission : 2015-02-27
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-29
Pay. Date : 2014-07-14
DMF Number : 28392
Submission : 2014-06-30
Status :
Type : II
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-03
Pay. Date : 2018-07-09
DMF Number : 32929
Submission : 2018-09-14
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36973
Submission : 2022-04-27
Status :
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33821
Submission : 2019-04-26
Status :
Type : II
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40421
Submission : 2024-10-24
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2018-02-08
Registration Number : No. 574-10-ND
Manufacturer Name : Dr. Reddy's Laboratories Lim...
Manufacturer Address : Chemical Technical Operations-Unit VI, APIIC Industrial Estate, Pydibhimavaram, Ranas...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Chong Kun Dang Co., Ltd.
Registration Date : 2020-08-27
Registration Number : No. 574-10-ND(2)
Manufacturer Name : Dr. Reddy's Laboratories Lim...
Manufacturer Address : Chemical Technical Operations-Unit VI, APIIC Industrial Estate, Pydibhimavaram, Ranas...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2020-09-29
Registration Number : 434-22-ND
Manufacturer Name : ZCL Chemicals Limited
Manufacturer Address : Plot No. 3102/B GIDC, Industrial Estate Ankleshwar City : Ankleshwar - 393 002, Dist....
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2021-07-13
Registration Number : Su434-22-ND(1)
Manufacturer Name : ZCL Chemicals Limited
Manufacturer Address : Plot No. 3102/B GIDC, Industrial Estate Ankleshwar City : Ankleshwar - 393 002, Dist....
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Huseeed Co., Ltd.
Registration Date : 2025-06-26
Registration Number : 434-74-ND(1)
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2025-03-18
Registration Number : 434-74-ND
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 25MG
USFDA APPLICATION NUMBER - 202611
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG
USFDA APPLICATION NUMBER - 202611
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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47
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.
A Mirabegron (USAN/JAN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirabegron (USAN/JAN), including repackagers and relabelers. The FDA regulates Mirabegron (USAN/JAN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirabegron (USAN/JAN) 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 (USAN/JAN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mirabegron (USAN/JAN) supplier is an individual or a company that provides Mirabegron (USAN/JAN) active pharmaceutical ingredient (API) or Mirabegron (USAN/JAN) finished formulations upon request. The Mirabegron (USAN/JAN) suppliers may include Mirabegron (USAN/JAN) API manufacturers, exporters, distributors and traders.
click here to find a list of Mirabegron (USAN/JAN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mirabegron (USAN/JAN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Mirabegron (USAN/JAN) active pharmaceutical ingredient (API) in detail. Different forms of Mirabegron (USAN/JAN) DMFs exist exist since differing nations have different regulations, such as Mirabegron (USAN/JAN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mirabegron (USAN/JAN) DMF submitted to regulatory agencies in the US is known as a USDMF. Mirabegron (USAN/JAN) USDMF includes data on Mirabegron (USAN/JAN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mirabegron (USAN/JAN) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mirabegron (USAN/JAN) suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Mirabegron (USAN/JAN) Drug Master File in Korea (Mirabegron (USAN/JAN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mirabegron (USAN/JAN). The MFDS reviews the Mirabegron (USAN/JAN) KDMF as part of the drug registration process and uses the information provided in the Mirabegron (USAN/JAN) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mirabegron (USAN/JAN) 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 (USAN/JAN) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mirabegron (USAN/JAN) suppliers with KDMF on PharmaCompass.
A Mirabegron (USAN/JAN) CEP of the European Pharmacopoeia monograph is often referred to as a Mirabegron (USAN/JAN) Certificate of Suitability (COS). The purpose of a Mirabegron (USAN/JAN) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mirabegron (USAN/JAN) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mirabegron (USAN/JAN) to their clients by showing that a Mirabegron (USAN/JAN) CEP has been issued for it. The manufacturer submits a Mirabegron (USAN/JAN) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mirabegron (USAN/JAN) CEP holder for the record. Additionally, the data presented in the Mirabegron (USAN/JAN) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mirabegron (USAN/JAN) DMF.
A Mirabegron (USAN/JAN) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mirabegron (USAN/JAN) CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Mirabegron (USAN/JAN) suppliers with CEP (COS) on PharmaCompass.
A Mirabegron (USAN/JAN) written confirmation (Mirabegron (USAN/JAN) WC) is an official document issued by a regulatory agency to a Mirabegron (USAN/JAN) manufacturer, verifying that the manufacturing facility of a Mirabegron (USAN/JAN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mirabegron (USAN/JAN) APIs or Mirabegron (USAN/JAN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Mirabegron (USAN/JAN) WC (written confirmation) as part of the regulatory process.
click here to find a list of Mirabegron (USAN/JAN) suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Mirabegron (USAN/JAN) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mirabegron (USAN/JAN) API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Mirabegron (USAN/JAN) as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Mirabegron (USAN/JAN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mirabegron (USAN/JAN) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mirabegron (USAN/JAN) suppliers with NDC on PharmaCompass.
Mirabegron (USAN/JAN) Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Mirabegron (USAN/JAN) GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Mirabegron (USAN/JAN) GMP manufacturer or Mirabegron (USAN/JAN) GMP API supplier for your needs.
A Mirabegron (USAN/JAN) CoA (Certificate of Analysis) is a formal document that attests to Mirabegron (USAN/JAN)'s compliance with Mirabegron (USAN/JAN) specifications and serves as a tool for batch-level quality control.
Mirabegron (USAN/JAN) CoA mostly includes findings from lab analyses of a specific batch. For each Mirabegron (USAN/JAN) CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Mirabegron (USAN/JAN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Mirabegron (USAN/JAN) EP), Mirabegron (USAN/JAN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mirabegron (USAN/JAN) USP).
