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API SUPPLIERS
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USDMF
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21974
Submission : 2008-12-30
Status :
Type : II
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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Date of Issue : 2022-07-07
Valid Till : 2025-07-21
Written Confirmation Number : WC-0150
Address of the Firm : R. S. No. 50/1, Mukteswarapuram (V), Jaggalahpet (M), Krishna -District- 521175,...
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Epinastine Hydrochloride BP/EP
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0156
Address of the Firm : 61-B, Bommasandra Industrial Area, Bengaluru-560 099, India
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INTERMEDIATE SUPPLIERS
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Regulatory Info :
Registration Country : Switzerland
Brand Name : Relestat
Dosage Form : Gtt Opht
Dosage Strength : 0.05%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : Relestat
Dosage Form : EYE DROPS, SOLUTION
Dosage Strength : 0.5 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Relestat
Dosage Form :
Dosage Strength : Coll 5 Ml 0,5 Mg/Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Relestat
Dosage Form : OPD
Dosage Strength : 10mg/ml
Packaging : 5X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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PharmaCompass offers a list of Epinastine 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 Epinastine Hydrochloride manufacturer or Epinastine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Epinastine Hydrochloride manufacturer or Epinastine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Epinastine Hydrochloride API Price utilized in the formulation of products. Epinastine Hydrochloride API Price is not always fixed or binding as the Epinastine Hydrochloride Price is obtained through a variety of data sources. The Epinastine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Epinastine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epinastine Hydrochloride, including repackagers and relabelers. The FDA regulates Epinastine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epinastine 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 Epinastine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Epinastine Hydrochloride supplier is an individual or a company that provides Epinastine Hydrochloride active pharmaceutical ingredient (API) or Epinastine Hydrochloride finished formulations upon request. The Epinastine Hydrochloride suppliers may include Epinastine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Epinastine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Epinastine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Epinastine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Epinastine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Epinastine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Epinastine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Epinastine Hydrochloride USDMF includes data on Epinastine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Epinastine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Epinastine 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 Epinastine Hydrochloride Drug Master File in Japan (Epinastine Hydrochloride JDMF) empowers Epinastine 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 Epinastine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Epinastine 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 Epinastine 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 Epinastine Hydrochloride Drug Master File in Korea (Epinastine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Epinastine Hydrochloride. The MFDS reviews the Epinastine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Epinastine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Epinastine 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 Epinastine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Epinastine Hydrochloride suppliers with KDMF on PharmaCompass.
A Epinastine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Epinastine Hydrochloride Certificate of Suitability (COS). The purpose of a Epinastine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Epinastine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Epinastine Hydrochloride to their clients by showing that a Epinastine Hydrochloride CEP has been issued for it. The manufacturer submits a Epinastine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Epinastine Hydrochloride CEP holder for the record. Additionally, the data presented in the Epinastine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Epinastine Hydrochloride DMF.
A Epinastine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Epinastine 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 Epinastine Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Epinastine Hydrochloride written confirmation (Epinastine Hydrochloride WC) is an official document issued by a regulatory agency to a Epinastine Hydrochloride manufacturer, verifying that the manufacturing facility of a Epinastine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Epinastine Hydrochloride APIs or Epinastine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Epinastine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Epinastine 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 Epinastine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Epinastine 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 Epinastine 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 Epinastine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Epinastine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Epinastine Hydrochloride suppliers with NDC on PharmaCompass.
Epinastine 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 Epinastine 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 Epinastine Hydrochloride GMP manufacturer or Epinastine Hydrochloride GMP API supplier for your needs.
A Epinastine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Epinastine Hydrochloride's compliance with Epinastine Hydrochloride specifications and serves as a tool for batch-level quality control.
Epinastine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Epinastine 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.
Epinastine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Epinastine Hydrochloride EP), Epinastine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Epinastine Hydrochloride USP).
