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API SUPPLIERS
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USDMF
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-01
Pay. Date : 2023-09-22
DMF Number : 36205
Submission : 2021-10-09
Status :
Type : II
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15440
Submission : 2001-05-15
Status :
Type : II
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Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
Certificate Number : R0-CEP 2021-124 - Rev 00
Status : Valid
Issue Date : 2022-08-10
Type : Chemical
Substance Number : 1633
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Certificate Number : CEP 2009-333 - Rev 05
Status : Valid
Issue Date : 2024-04-24
Type : Chemical
Substance Number : 1633
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Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Nasal Spray
Dosage Strength : 0.1%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Azelastine Hydrochloride; Fluticasone Propionate
Brand Name :
Dosage Form : Nasal Spray
Dosage Strength : 140MCG; 27.5MCG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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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- SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Viatris brand of azelastine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Viatris brand of azelastine hydrochloride, including repackagers and relabelers. The FDA regulates Viatris brand of azelastine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Viatris brand of azelastine hydrochloride 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 Viatris brand of azelastine hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Viatris brand of azelastine hydrochloride supplier is an individual or a company that provides Viatris brand of azelastine hydrochloride active pharmaceutical ingredient (API) or Viatris brand of azelastine hydrochloride finished formulations upon request. The Viatris brand of azelastine hydrochloride suppliers may include Viatris brand of azelastine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Viatris brand of azelastine hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Viatris brand of azelastine hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Viatris brand of azelastine hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Viatris brand of azelastine hydrochloride DMFs exist exist since differing nations have different regulations, such as Viatris brand of azelastine hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Viatris brand of azelastine hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Viatris brand of azelastine hydrochloride USDMF includes data on Viatris brand of azelastine hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Viatris brand of azelastine hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Viatris brand of azelastine hydrochloride 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 Viatris brand of azelastine hydrochloride Drug Master File in Japan (Viatris brand of azelastine hydrochloride JDMF) empowers Viatris brand of azelastine hydrochloride 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 Viatris brand of azelastine hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Viatris brand of azelastine hydrochloride 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 Viatris brand of azelastine hydrochloride 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 Viatris brand of azelastine hydrochloride Drug Master File in Korea (Viatris brand of azelastine hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Viatris brand of azelastine hydrochloride. The MFDS reviews the Viatris brand of azelastine hydrochloride KDMF as part of the drug registration process and uses the information provided in the Viatris brand of azelastine hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Viatris brand of azelastine hydrochloride 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 Viatris brand of azelastine hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Viatris brand of azelastine hydrochloride suppliers with KDMF on PharmaCompass.
A Viatris brand of azelastine hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Viatris brand of azelastine hydrochloride Certificate of Suitability (COS). The purpose of a Viatris brand of azelastine hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Viatris brand of azelastine hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Viatris brand of azelastine hydrochloride to their clients by showing that a Viatris brand of azelastine hydrochloride CEP has been issued for it. The manufacturer submits a Viatris brand of azelastine hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Viatris brand of azelastine hydrochloride CEP holder for the record. Additionally, the data presented in the Viatris brand of azelastine hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Viatris brand of azelastine hydrochloride DMF.
A Viatris brand of azelastine hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Viatris brand of azelastine hydrochloride 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 Viatris brand of azelastine hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Viatris brand of azelastine hydrochloride written confirmation (Viatris brand of azelastine hydrochloride WC) is an official document issued by a regulatory agency to a Viatris brand of azelastine hydrochloride manufacturer, verifying that the manufacturing facility of a Viatris brand of azelastine hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Viatris brand of azelastine hydrochloride APIs or Viatris brand of azelastine hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Viatris brand of azelastine hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Viatris brand of azelastine hydrochloride 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 Viatris brand of azelastine hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Viatris brand of azelastine hydrochloride 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 Viatris brand of azelastine hydrochloride 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 Viatris brand of azelastine hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Viatris brand of azelastine hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Viatris brand of azelastine hydrochloride suppliers with NDC on PharmaCompass.
Viatris brand of azelastine hydrochloride 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 Viatris brand of azelastine hydrochloride 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 Viatris brand of azelastine hydrochloride GMP manufacturer or Viatris brand of azelastine hydrochloride GMP API supplier for your needs.
A Viatris brand of azelastine hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Viatris brand of azelastine hydrochloride's compliance with Viatris brand of azelastine hydrochloride specifications and serves as a tool for batch-level quality control.
Viatris brand of azelastine hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Viatris brand of azelastine hydrochloride 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.
Viatris brand of azelastine hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Viatris brand of azelastine hydrochloride EP), Viatris brand of azelastine hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Viatris brand of azelastine hydrochloride USP).
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