Synopsis
0
JDMF
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
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.
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
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.
NDC
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
NDC
KDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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 : 2014-09-29
Pay. Date : 2014-07-14
DMF Number : 28392
Submission : 2014-06-30
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
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
About the Company : Synnat Pharma is a fast-growing pharmaceutical company dedicated to the identification, development, production and distribution of potent phytochemicals and botanical extracts. AP...
Neuland Laboratories- A dedicated 100% API provider.
About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
About the Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported b...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Minakem is manufacturing small molecules APIs including corticosteroids
About the Company : Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our em...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info :
Registration Country : Greece
Brand Name :
Dosage Form : Prolonged Release Tabl...
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info :
Registration Country : Greece
Brand Name :
Dosage Form : Prolonged Release Tabl...
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Greece
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
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finished Drug Prices
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
APIs
Reply
13 Sep 2024
Reply
10 Sep 2024
Reply
15 Jan 2024
Reply
14 Nov 2023
Reply
06 Jun 2023
Reply
05 May 2023
Reply
11 Feb 2023
Reply
06 Jul 2022
Reply
15 Apr 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
FDF DOSSIERS
Reply
26 Sep 2024
Reply
04 Dec 2020
Reply
09 Oct 2018
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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.
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.
A Mirabegron DMF (Drug Master File) is a document detailing the whole manufacturing process of Mirabegron active pharmaceutical ingredient (API) in detail. Different forms of Mirabegron DMFs exist exist since differing nations have different regulations, such as Mirabegron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mirabegron DMF submitted to regulatory agencies in the US is known as a USDMF. Mirabegron USDMF includes data on Mirabegron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mirabegron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mirabegron 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 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.
A Mirabegron CEP of the European Pharmacopoeia monograph is often referred to as a Mirabegron Certificate of Suitability (COS). The purpose of a Mirabegron CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mirabegron EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mirabegron to their clients by showing that a Mirabegron CEP has been issued for it. The manufacturer submits a Mirabegron CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mirabegron CEP holder for the record. Additionally, the data presented in the Mirabegron CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mirabegron DMF.
A Mirabegron CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mirabegron 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 suppliers with CEP (COS) on PharmaCompass.
A Mirabegron written confirmation (Mirabegron WC) is an official document issued by a regulatory agency to a Mirabegron manufacturer, verifying that the manufacturing facility of a Mirabegron active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mirabegron APIs or Mirabegron finished pharmaceutical products to another nation, regulatory agencies frequently require a Mirabegron WC (written confirmation) as part of the regulatory process.
click here to find a list of Mirabegron 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mirabegron 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mirabegron NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mirabegron suppliers with NDC on PharmaCompass.
Mirabegron 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 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 GMP manufacturer or Mirabegron GMP API supplier for your needs.
A Mirabegron CoA (Certificate of Analysis) is a formal document that attests to Mirabegron's compliance with Mirabegron specifications and serves as a tool for batch-level quality control.
Mirabegron CoA mostly includes findings from lab analyses of a specific batch. For each Mirabegron 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Mirabegron EP), Mirabegron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mirabegron USP).
LOOKING FOR A SUPPLIER?
Comment (4)
