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API SUPPLIERS
Axplora is your partner of choice for complex APIs.
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NDC
KDMF
EU, CA, ...
With Fermion, start the journey of your innovative API.
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CEP/COS
NDC
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
CEP/COS
JDMF
NDC
KDMF
CA, CN
Axplora is your partner of choice for complex APIs.
EU, CA, ...
Axplora is your partner of choice for complex APIs.
EU, CA, ...
Axplora is your partner of choice for complex APIs.
EU, CA, ...
Axplora is your partner of choice for complex APIs.
EU, CA, ...
Axplora is your partner of choice for complex APIs.
EU, CA, ...
Axplora is your partner of choice for complex APIs.
EU, CA, ...
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USDMF
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-15
DMF Number : 10641
Submission : 1993-12-16
Status :
Type : II
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-23
Pay. Date : 2014-05-14
DMF Number : 11568
Submission : 1995-06-29
Status :
Type : II
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-04
Pay. Date : 2013-08-28
DMF Number : 23537
Submission : 2010-02-04
Status :
Type : II
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SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Registration Number : 224MF10096
Registrant's Address : No. 61, Ln. 309, Haihu N. Rd. , Luzhu Dist. , Taoyuan City 33856, Taiwan
Initial Date of Registration : 2012-05-08
Latest Date of Registration : 2024-07-24
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Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pilot plants, and produ...
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INTERMEDIATE SUPPLIERS
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
1-(2-Hydroxyphenyl)-3-phenylpropan-1-one
CAS Number : 3516-95-8
End Use API : Propafenone Hydrochloride
About The Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pil...
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DOSAGE - TABLET;ORAL - 150MG **Federal Regist...DOSAGE - TABLET;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19151
DOSAGE - TABLET;ORAL - 225MG **Federal Regist...DOSAGE - TABLET;ORAL - 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19151
DOSAGE - TABLET;ORAL - 300MG **Federal Regist...DOSAGE - TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19151
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 225...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 225MG
USFDA APPLICATION NUMBER - 21416
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 325...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 325MG
USFDA APPLICATION NUMBER - 21416
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 425...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 425MG
USFDA APPLICATION NUMBER - 21416
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Propafenone Hydrochloride 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 Propafenone Hydrochloride manufacturer or Propafenone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Propafenone Hydrochloride manufacturer or Propafenone Hydrochloride supplier.
PharmaCompass also assists you with knowing the Propafenone Hydrochloride API Price utilized in the formulation of products. Propafenone Hydrochloride API Price is not always fixed or binding as the Propafenone Hydrochloride Price is obtained through a variety of data sources. The Propafenone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rytmonorm manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rytmonorm, including repackagers and relabelers. The FDA regulates Rytmonorm manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rytmonorm 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 Rytmonorm manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rytmonorm supplier is an individual or a company that provides Rytmonorm active pharmaceutical ingredient (API) or Rytmonorm finished formulations upon request. The Rytmonorm suppliers may include Rytmonorm API manufacturers, exporters, distributors and traders.
click here to find a list of Rytmonorm suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rytmonorm DMF (Drug Master File) is a document detailing the whole manufacturing process of Rytmonorm active pharmaceutical ingredient (API) in detail. Different forms of Rytmonorm DMFs exist exist since differing nations have different regulations, such as Rytmonorm USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rytmonorm DMF submitted to regulatory agencies in the US is known as a USDMF. Rytmonorm USDMF includes data on Rytmonorm's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rytmonorm USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rytmonorm 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 Rytmonorm Drug Master File in Japan (Rytmonorm JDMF) empowers Rytmonorm 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 Rytmonorm JDMF during the approval evaluation for pharmaceutical products. At the time of Rytmonorm 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 Rytmonorm 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 Rytmonorm Drug Master File in Korea (Rytmonorm KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rytmonorm. The MFDS reviews the Rytmonorm KDMF as part of the drug registration process and uses the information provided in the Rytmonorm KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rytmonorm 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 Rytmonorm API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rytmonorm suppliers with KDMF on PharmaCompass.
A Rytmonorm CEP of the European Pharmacopoeia monograph is often referred to as a Rytmonorm Certificate of Suitability (COS). The purpose of a Rytmonorm CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rytmonorm EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rytmonorm to their clients by showing that a Rytmonorm CEP has been issued for it. The manufacturer submits a Rytmonorm CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rytmonorm CEP holder for the record. Additionally, the data presented in the Rytmonorm CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rytmonorm DMF.
A Rytmonorm CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rytmonorm 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 Rytmonorm suppliers with CEP (COS) on PharmaCompass.
A Rytmonorm written confirmation (Rytmonorm WC) is an official document issued by a regulatory agency to a Rytmonorm manufacturer, verifying that the manufacturing facility of a Rytmonorm active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rytmonorm APIs or Rytmonorm finished pharmaceutical products to another nation, regulatory agencies frequently require a Rytmonorm WC (written confirmation) as part of the regulatory process.
click here to find a list of Rytmonorm 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 Rytmonorm as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rytmonorm 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 Rytmonorm 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 Rytmonorm and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rytmonorm NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rytmonorm suppliers with NDC on PharmaCompass.
Rytmonorm 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 Rytmonorm 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 Rytmonorm GMP manufacturer or Rytmonorm GMP API supplier for your needs.
A Rytmonorm CoA (Certificate of Analysis) is a formal document that attests to Rytmonorm's compliance with Rytmonorm specifications and serves as a tool for batch-level quality control.
Rytmonorm CoA mostly includes findings from lab analyses of a specific batch. For each Rytmonorm 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.
Rytmonorm may be tested according to a variety of international standards, such as European Pharmacopoeia (Rytmonorm EP), Rytmonorm JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rytmonorm USP).
