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Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
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Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20114
DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY
USFDA APPLICATION NUMBER - 202236
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.05% **...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21127
DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22203
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ABOUT THIS PAGE
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PharmaCompass offers a list of Azelastine 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 Azelastine Hydrochloride manufacturer or Azelastine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Azelastine Hydrochloride manufacturer or Azelastine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Azelastine Hydrochloride API Price utilized in the formulation of products. Azelastine Hydrochloride API Price is not always fixed or binding as the Azelastine Hydrochloride Price is obtained through a variety of data sources. The Azelastine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Loxin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Loxin, including repackagers and relabelers. The FDA regulates Loxin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Loxin 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 Loxin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Loxin supplier is an individual or a company that provides Loxin active pharmaceutical ingredient (API) or Loxin finished formulations upon request. The Loxin suppliers may include Loxin API manufacturers, exporters, distributors and traders.
click here to find a list of Loxin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Loxin DMF (Drug Master File) is a document detailing the whole manufacturing process of Loxin active pharmaceutical ingredient (API) in detail. Different forms of Loxin DMFs exist exist since differing nations have different regulations, such as Loxin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Loxin DMF submitted to regulatory agencies in the US is known as a USDMF. Loxin USDMF includes data on Loxin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Loxin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Loxin 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 Loxin Drug Master File in Japan (Loxin JDMF) empowers Loxin 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 Loxin JDMF during the approval evaluation for pharmaceutical products. At the time of Loxin 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 Loxin 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 Loxin Drug Master File in Korea (Loxin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Loxin. The MFDS reviews the Loxin KDMF as part of the drug registration process and uses the information provided in the Loxin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Loxin 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 Loxin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Loxin suppliers with KDMF on PharmaCompass.
A Loxin CEP of the European Pharmacopoeia monograph is often referred to as a Loxin Certificate of Suitability (COS). The purpose of a Loxin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Loxin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Loxin to their clients by showing that a Loxin CEP has been issued for it. The manufacturer submits a Loxin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Loxin CEP holder for the record. Additionally, the data presented in the Loxin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Loxin DMF.
A Loxin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Loxin 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 Loxin suppliers with CEP (COS) on PharmaCompass.
A Loxin written confirmation (Loxin WC) is an official document issued by a regulatory agency to a Loxin manufacturer, verifying that the manufacturing facility of a Loxin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Loxin APIs or Loxin finished pharmaceutical products to another nation, regulatory agencies frequently require a Loxin WC (written confirmation) as part of the regulatory process.
click here to find a list of Loxin 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 Loxin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Loxin 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 Loxin 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 Loxin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Loxin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Loxin suppliers with NDC on PharmaCompass.
Loxin 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 Loxin 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 Loxin GMP manufacturer or Loxin GMP API supplier for your needs.
A Loxin CoA (Certificate of Analysis) is a formal document that attests to Loxin's compliance with Loxin specifications and serves as a tool for batch-level quality control.
Loxin CoA mostly includes findings from lab analyses of a specific batch. For each Loxin 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.
Loxin may be tested according to a variety of international standards, such as European Pharmacopoeia (Loxin EP), Loxin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Loxin USP).
