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API SUPPLIERS
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Jai Radhe Sales is your partner for all your sourcing needs.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Certificate Number : CEP 2017-054 - Rev 01
Status : Valid
Issue Date : 2024-03-25
Type : Chemical
Substance Number : 1162
Certificate Number : R1-CEP 2011-369 - Rev 01
Status : Valid
Issue Date : 2020-03-03
Type : Chemical
Substance Number : 1162
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
Certificate Number : R1-CEP 2006-286 - Rev 01
Status : Valid
Issue Date : 2015-12-15
Type : Chemical
Substance Number : 1162
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
Certificate Number : R1-CEP 2000-061 - Rev 03
Status : Valid
Issue Date : 2015-12-10
Type : Chemical
Substance Number : 1162
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PharmaCompass offers a list of Xylometazoline 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 Xylometazoline Hydrochloride manufacturer or Xylometazoline Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Xylometazoline Hydrochloride manufacturer or Xylometazoline Hydrochloride supplier.
PharmaCompass also assists you with knowing the Xylometazoline Hydrochloride API Price utilized in the formulation of products. Xylometazoline Hydrochloride API Price is not always fixed or binding as the Xylometazoline Hydrochloride Price is obtained through a variety of data sources. The Xylometazoline Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Otriven manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Otriven, including repackagers and relabelers. The FDA regulates Otriven manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Otriven 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 Otriven manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Otriven supplier is an individual or a company that provides Otriven active pharmaceutical ingredient (API) or Otriven finished formulations upon request. The Otriven suppliers may include Otriven API manufacturers, exporters, distributors and traders.
click here to find a list of Otriven suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Otriven DMF (Drug Master File) is a document detailing the whole manufacturing process of Otriven active pharmaceutical ingredient (API) in detail. Different forms of Otriven DMFs exist exist since differing nations have different regulations, such as Otriven USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Otriven DMF submitted to regulatory agencies in the US is known as a USDMF. Otriven USDMF includes data on Otriven's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Otriven USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Otriven 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 Otriven Drug Master File in Korea (Otriven KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Otriven. The MFDS reviews the Otriven KDMF as part of the drug registration process and uses the information provided in the Otriven KDMF to evaluate the safety and efficacy of the drug.
After submitting a Otriven 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 Otriven API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Otriven suppliers with KDMF on PharmaCompass.
A Otriven CEP of the European Pharmacopoeia monograph is often referred to as a Otriven Certificate of Suitability (COS). The purpose of a Otriven CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Otriven EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Otriven to their clients by showing that a Otriven CEP has been issued for it. The manufacturer submits a Otriven CEP (COS) as part of the market authorization procedure, and it takes on the role of a Otriven CEP holder for the record. Additionally, the data presented in the Otriven CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Otriven DMF.
A Otriven CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Otriven 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 Otriven suppliers with CEP (COS) 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 Otriven as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Otriven 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 Otriven 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 Otriven and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Otriven NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Otriven suppliers with NDC on PharmaCompass.
Otriven 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 Otriven 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 Otriven GMP manufacturer or Otriven GMP API supplier for your needs.
A Otriven CoA (Certificate of Analysis) is a formal document that attests to Otriven's compliance with Otriven specifications and serves as a tool for batch-level quality control.
Otriven CoA mostly includes findings from lab analyses of a specific batch. For each Otriven 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.
Otriven may be tested according to a variety of international standards, such as European Pharmacopoeia (Otriven EP), Otriven JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Otriven USP).
