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DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18703
DOSAGE - TABLET;ORAL - EQ 300MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18703
DOSAGE - INJECTABLE;INJECTION - EQ 25MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 25MG BASE/ML
USFDA APPLICATION NUMBER - 19090
DOSAGE - TABLET;ORAL - EQ 75MG BASE
USFDA APPLICATION NUMBER - 20520
DOSAGE - TABLET;ORAL - EQ 150MG BASE
USFDA APPLICATION NUMBER - 21698
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ABOUT THIS PAGE
40
PharmaCompass offers a list of Ranitidine 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 Ranitidine Hydrochloride manufacturer or Ranitidine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ranitidine Hydrochloride manufacturer or Ranitidine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Ranitidine Hydrochloride API Price utilized in the formulation of products. Ranitidine Hydrochloride API Price is not always fixed or binding as the Ranitidine Hydrochloride Price is obtained through a variety of data sources. The Ranitidine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ranigen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ranigen, including repackagers and relabelers. The FDA regulates Ranigen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ranigen 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 Ranigen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ranigen supplier is an individual or a company that provides Ranigen active pharmaceutical ingredient (API) or Ranigen finished formulations upon request. The Ranigen suppliers may include Ranigen API manufacturers, exporters, distributors and traders.
click here to find a list of Ranigen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ranigen DMF (Drug Master File) is a document detailing the whole manufacturing process of Ranigen active pharmaceutical ingredient (API) in detail. Different forms of Ranigen DMFs exist exist since differing nations have different regulations, such as Ranigen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ranigen DMF submitted to regulatory agencies in the US is known as a USDMF. Ranigen USDMF includes data on Ranigen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ranigen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ranigen 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 Ranigen Drug Master File in Japan (Ranigen JDMF) empowers Ranigen 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 Ranigen JDMF during the approval evaluation for pharmaceutical products. At the time of Ranigen 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 Ranigen 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 Ranigen Drug Master File in Korea (Ranigen KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ranigen. The MFDS reviews the Ranigen KDMF as part of the drug registration process and uses the information provided in the Ranigen KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ranigen 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 Ranigen API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ranigen suppliers with KDMF on PharmaCompass.
A Ranigen CEP of the European Pharmacopoeia monograph is often referred to as a Ranigen Certificate of Suitability (COS). The purpose of a Ranigen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ranigen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ranigen to their clients by showing that a Ranigen CEP has been issued for it. The manufacturer submits a Ranigen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ranigen CEP holder for the record. Additionally, the data presented in the Ranigen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ranigen DMF.
A Ranigen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ranigen 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 Ranigen suppliers with CEP (COS) on PharmaCompass.
A Ranigen written confirmation (Ranigen WC) is an official document issued by a regulatory agency to a Ranigen manufacturer, verifying that the manufacturing facility of a Ranigen active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ranigen APIs or Ranigen finished pharmaceutical products to another nation, regulatory agencies frequently require a Ranigen WC (written confirmation) as part of the regulatory process.
click here to find a list of Ranigen 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 Ranigen as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ranigen 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 Ranigen 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 Ranigen and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ranigen NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ranigen suppliers with NDC on PharmaCompass.
Ranigen 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 Ranigen 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 Ranigen GMP manufacturer or Ranigen GMP API supplier for your needs.
A Ranigen CoA (Certificate of Analysis) is a formal document that attests to Ranigen's compliance with Ranigen specifications and serves as a tool for batch-level quality control.
Ranigen CoA mostly includes findings from lab analyses of a specific batch. For each Ranigen 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.
Ranigen may be tested according to a variety of international standards, such as European Pharmacopoeia (Ranigen EP), Ranigen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ranigen USP).
