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ABOUT THIS PAGE
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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, 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.
A Otrivin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Otrivin, including repackagers and relabelers. The FDA regulates Otrivin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Otrivin 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 Otrivin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Otrivin supplier is an individual or a company that provides Otrivin active pharmaceutical ingredient (API) or Otrivin finished formulations upon request. The Otrivin suppliers may include Otrivin API manufacturers, exporters, distributors and traders.
click here to find a list of Otrivin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Otrivin DMF (Drug Master File) is a document detailing the whole manufacturing process of Otrivin active pharmaceutical ingredient (API) in detail. Different forms of Otrivin DMFs exist exist since differing nations have different regulations, such as Otrivin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Otrivin DMF submitted to regulatory agencies in the US is known as a USDMF. Otrivin USDMF includes data on Otrivin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Otrivin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Otrivin 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 Otrivin Drug Master File in Korea (Otrivin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Otrivin. The MFDS reviews the Otrivin KDMF as part of the drug registration process and uses the information provided in the Otrivin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Otrivin 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 Otrivin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Otrivin suppliers with KDMF on PharmaCompass.
A Otrivin CEP of the European Pharmacopoeia monograph is often referred to as a Otrivin Certificate of Suitability (COS). The purpose of a Otrivin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Otrivin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Otrivin to their clients by showing that a Otrivin CEP has been issued for it. The manufacturer submits a Otrivin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Otrivin CEP holder for the record. Additionally, the data presented in the Otrivin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Otrivin DMF.
A Otrivin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Otrivin 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 Otrivin 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 Otrivin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Otrivin 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 Otrivin 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 Otrivin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Otrivin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Otrivin suppliers with NDC on PharmaCompass.
Otrivin 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 Otrivin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Otrivin GMP manufacturer or Otrivin GMP API supplier for your needs.
A Otrivin CoA (Certificate of Analysis) is a formal document that attests to Otrivin's compliance with Otrivin specifications and serves as a tool for batch-level quality control.
Otrivin CoA mostly includes findings from lab analyses of a specific batch. For each Otrivin 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.
Otrivin may be tested according to a variety of international standards, such as European Pharmacopoeia (Otrivin EP), Otrivin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Otrivin USP).
