Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
US Patents
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US Exclusivities
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Health Canada Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35650
Submission : 2021-02-16
Status :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-11
Pay. Date : 2015-09-04
DMF Number : 15083
Submission : 2000-10-10
Status :
Type : II
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Reliable Spanish CDMO Delivering High-Quality APIs and Intermediates with Excellence, Flexibility, and Regulatory Compliance.
Certificate Number : R1-CEP 2015-243 - Rev 00
Status : Valid
Issue Date : 2022-02-03
Type : Chemical
Substance Number : 1710
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Certificate Number : CEP 2009-044 - Rev 02
Status : Valid
Issue Date : 2024-08-16
Type : Chemical
Substance Number : 1710
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Certificate Number : R0-CEP 2020-095 - Rev 00
Status : Valid
Issue Date : 2022-05-04
Type : Chemical
Substance Number : 1710
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
Certificate Number : CEP 2016-139 - Rev 01
Status : Valid
Issue Date : 2024-01-23
Type : Chemical
Substance Number : 1710
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Registration Number : 218MF10893
Registrant's Address : Cesar Martinell i Brunet 12A, Poligono Rubi Sur, Rubi (Barcelona), Spain
Initial Date of Registration : 2006-11-10
Latest Date of Registration : 2019-09-11
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
Registration Number : 230MF10053
Registrant's Address : No. 8, Xiyuan Avenue, Hi-Tech District, Chengdu, 611731, China.
Initial Date of Registration : 2018-04-17
Latest Date of Registration : 2018-04-17
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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;ORAL - 10MG **Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19982
DOSAGE - TABLET;ORAL - 5MG **Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19982
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Coating Systems & Additives
Direct Compression
Controlled & Modified Release
Thickeners and Stabilizers
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Solubilizers
Disintegrants & Superdisintegrants
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Digital Content
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Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Regulatory FDF Prices
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
RX/OTC/DISCN :
Dosage Form : Tablets
Dosage Strength : 1.25 mg
Price Per Pack (Euro) : 2.41
Published in :
Country : Italy
RX/OTC/DISCN :
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
RX/OTC/DISCN :
Dosage Form : Coated Tablets
Dosage Strength : 2.5 mg
Price Per Pack (Euro) : 2.59
Published in :
Country : Italy
RX/OTC/DISCN :
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
RX/OTC/DISCN :
Dosage Form : Coated Tablets
Dosage Strength : 5 mg
Price Per Pack (Euro) : 4.48
Published in :
Country : Italy
RX/OTC/DISCN :
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
RX/OTC/DISCN :
Dosage Form : Tablets
Dosage Strength : 7.5 mg
Price Per Pack (Euro) : 3.37
Published in :
Country : Italy
RX/OTC/DISCN :
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
49
PharmaCompass offers a list of Bisoprolol Fumarate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Bisoprolol Fumarate manufacturer or Bisoprolol Fumarate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bisoprolol Fumarate manufacturer or Bisoprolol Fumarate supplier.
A Emcor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Emcor, including repackagers and relabelers. The FDA regulates Emcor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Emcor 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 Emcor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Emcor supplier is an individual or a company that provides Emcor active pharmaceutical ingredient (API) or Emcor finished formulations upon request. The Emcor suppliers may include Emcor API manufacturers, exporters, distributors and traders.
click here to find a list of Emcor suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Emcor DMF (Drug Master File) is a document detailing the whole manufacturing process of Emcor active pharmaceutical ingredient (API) in detail. Different forms of Emcor DMFs exist exist since differing nations have different regulations, such as Emcor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Emcor DMF submitted to regulatory agencies in the US is known as a USDMF. Emcor USDMF includes data on Emcor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Emcor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Emcor suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Emcor Drug Master File in Japan (Emcor JDMF) empowers Emcor API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Emcor JDMF during the approval evaluation for pharmaceutical products. At the time of Emcor JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Emcor suppliers with JDMF 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 Emcor Drug Master File in Korea (Emcor KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Emcor. The MFDS reviews the Emcor KDMF as part of the drug registration process and uses the information provided in the Emcor KDMF to evaluate the safety and efficacy of the drug.
After submitting a Emcor 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 Emcor API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Emcor suppliers with KDMF on PharmaCompass.
A Emcor CEP of the European Pharmacopoeia monograph is often referred to as a Emcor Certificate of Suitability (COS). The purpose of a Emcor CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Emcor EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Emcor to their clients by showing that a Emcor CEP has been issued for it. The manufacturer submits a Emcor CEP (COS) as part of the market authorization procedure, and it takes on the role of a Emcor CEP holder for the record. Additionally, the data presented in the Emcor CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Emcor DMF.
A Emcor CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Emcor 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 Emcor suppliers with CEP (COS) on PharmaCompass.
A Emcor written confirmation (Emcor WC) is an official document issued by a regulatory agency to a Emcor manufacturer, verifying that the manufacturing facility of a Emcor active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Emcor APIs or Emcor finished pharmaceutical products to another nation, regulatory agencies frequently require a Emcor WC (written confirmation) as part of the regulatory process.
click here to find a list of Emcor 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 Emcor as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Emcor 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 Emcor 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 Emcor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Emcor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Emcor suppliers with NDC on PharmaCompass.
Emcor 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 Emcor GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Emcor GMP manufacturer or Emcor GMP API supplier for your needs.
A Emcor CoA (Certificate of Analysis) is a formal document that attests to Emcor's compliance with Emcor specifications and serves as a tool for batch-level quality control.
Emcor CoA mostly includes findings from lab analyses of a specific batch. For each Emcor 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.
Emcor may be tested according to a variety of international standards, such as European Pharmacopoeia (Emcor EP), Emcor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Emcor USP).
