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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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EU-WC
NDC
Jai Radhe Sales is your partner for all your sourcing needs.
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35833
Submission : 2021-04-29
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Certificate Number : CEP 2022-117 - Rev 00
Status : Valid
Issue Date : 2023-11-27
Type : Chemical
Substance Number : 730
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Naphazoline Hydrochloride IH/USP/Ph.Eur
Date of Issue : 2025-02-27
Valid Till : 2028-02-26
Written Confirmation Number : WC-511n
Address of the Firm : Plot No. 80A, Road No.5, Jawaharlal Nehru Pharma City, E. Bonangi (V), Parawada ...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Naphazoline Hydrochloride IH/USP/Ph.Eur
Date of Issue : 2025-02-27
Valid Till : 2028-02-26
Written Confirmation Number : WC-0511
Address of the Firm : Plot No. 80A, Road No.5, Jawaharlal Nehru Pharma City, E. Bonangi (V), Parawada ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
About the Company : Laboratorium Ofichem is a GMP-certified and FDA-approved API manufacturer with state-of-the-art development and production facilities in the Netherlands. We develop and manufacture...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Tusamitamab Ravtansine,Dexamethasone,Naphazoline Hydrochloride,Diphenhydramine
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors
Details : Tusamitamab Ravtansine is a Antibody-drug Conjugate drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Neoplasms.
Product Name : Undisclosed
Product Type : Antibody-drug Conjugate
Upfront Cash : Inapplicable
October 27, 2017
Lead Product(s) : Alcaftadine,Naphazoline Hydrochloride,Pheniramine Maleate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Milton M. Hom
Deal Size : Inapplicable
Deal Type : Inapplicable
Comparison of Tolerability Between Two Allergy Drops
Details : Alcaftadine is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Conjunctivitis, Allergic.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 11, 2011
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
Regulatory Info : NON-PRESCRIPTION DRUGS
Registration Country : Canada
Brand Name : ALBALON
Dosage Form : DROPS
Dosage Strength : 0.1%/W/V
Packaging : 15ML
Approval Date :
Application Number : 1147
Regulatory Info : NON-PRESCRIPTION DRUGS
Registration Country : Canada
Regulatory Info : NON-PRESCRIPTION DRUGS
Registration Country : Canada
Brand Name : REFRESH EYE ALLERGY RELIEF
Dosage Form : SOLUTION
Dosage Strength : 0.051%
Packaging : 15ML
Approval Date :
Application Number : 2315890
Regulatory Info : NON-PRESCRIPTION DRUGS
Registration Country : Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Murine Clear Eyes
Dosage Form : OPD
Dosage Strength : 0.12mg/ml
Packaging : 15X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.02675%...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.02675%;0.315%
USFDA APPLICATION NUMBER - 20065
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.025%;0...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.025%;0.3%
USFDA APPLICATION NUMBER - 20485
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SPI Pharma
SPI Pharma has been solving formulation challenges using superior functional materials.
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Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
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Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
18
PharmaCompass offers a list of Naphazoline 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 Naphazoline Hydrochloride manufacturer or Naphazoline Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Naphazoline Hydrochloride manufacturer or Naphazoline Hydrochloride supplier.
PharmaCompass also assists you with knowing the Naphazoline Hydrochloride API Price utilized in the formulation of products. Naphazoline Hydrochloride API Price is not always fixed or binding as the Naphazoline Hydrochloride Price is obtained through a variety of data sources. The Naphazoline Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Naphazoline HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naphazoline HCl, including repackagers and relabelers. The FDA regulates Naphazoline HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naphazoline HCl 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 Naphazoline HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naphazoline HCl supplier is an individual or a company that provides Naphazoline HCl active pharmaceutical ingredient (API) or Naphazoline HCl finished formulations upon request. The Naphazoline HCl suppliers may include Naphazoline HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Naphazoline HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Naphazoline HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Naphazoline HCl active pharmaceutical ingredient (API) in detail. Different forms of Naphazoline HCl DMFs exist exist since differing nations have different regulations, such as Naphazoline HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Naphazoline HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Naphazoline HCl USDMF includes data on Naphazoline HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naphazoline HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Naphazoline HCl 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 Naphazoline HCl Drug Master File in Korea (Naphazoline HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Naphazoline HCl. The MFDS reviews the Naphazoline HCl KDMF as part of the drug registration process and uses the information provided in the Naphazoline HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Naphazoline HCl 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 Naphazoline HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Naphazoline HCl suppliers with KDMF on PharmaCompass.
A Naphazoline HCl CEP of the European Pharmacopoeia monograph is often referred to as a Naphazoline HCl Certificate of Suitability (COS). The purpose of a Naphazoline HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Naphazoline HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Naphazoline HCl to their clients by showing that a Naphazoline HCl CEP has been issued for it. The manufacturer submits a Naphazoline HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Naphazoline HCl CEP holder for the record. Additionally, the data presented in the Naphazoline HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Naphazoline HCl DMF.
A Naphazoline HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Naphazoline HCl 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 Naphazoline HCl suppliers with CEP (COS) on PharmaCompass.
A Naphazoline HCl written confirmation (Naphazoline HCl WC) is an official document issued by a regulatory agency to a Naphazoline HCl manufacturer, verifying that the manufacturing facility of a Naphazoline HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Naphazoline HCl APIs or Naphazoline HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Naphazoline HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Naphazoline HCl 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 Naphazoline HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Naphazoline HCl 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 Naphazoline HCl 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 Naphazoline HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Naphazoline HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Naphazoline HCl suppliers with NDC on PharmaCompass.
Naphazoline HCl 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 Naphazoline HCl 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 Naphazoline HCl GMP manufacturer or Naphazoline HCl GMP API supplier for your needs.
A Naphazoline HCl CoA (Certificate of Analysis) is a formal document that attests to Naphazoline HCl's compliance with Naphazoline HCl specifications and serves as a tool for batch-level quality control.
Naphazoline HCl CoA mostly includes findings from lab analyses of a specific batch. For each Naphazoline HCl 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.
Naphazoline HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Naphazoline HCl EP), Naphazoline HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Naphazoline HCl USP).
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