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Looking for 76963-41-2 / Nizatidine API manufacturers, exporters & distributors?

Nizatidine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Nizatidine 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 Nizatidine manufacturer or Nizatidine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nizatidine manufacturer or Nizatidine supplier.

PharmaCompass also assists you with knowing the Nizatidine API Price utilized in the formulation of products. Nizatidine API Price is not always fixed or binding as the Nizatidine Price is obtained through a variety of data sources. The Nizatidine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Nizatidine

Synonyms

76963-41-2, Axid, Zanizal, Nizax, Ly-139037, Niaztidine

Cas Number

76963-41-2

About Nizatidine

A histamine H2 receptor antagonist with low toxicity that inhibits gastric acid secretion. The drug is used for the treatment of duodenal ulcers.

Prestwick2_000921 Manufacturers

A Prestwick2_000921 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prestwick2_000921, including repackagers and relabelers. The FDA regulates Prestwick2_000921 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prestwick2_000921 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 Prestwick2_000921 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Prestwick2_000921 Suppliers

A Prestwick2_000921 supplier is an individual or a company that provides Prestwick2_000921 active pharmaceutical ingredient (API) or Prestwick2_000921 finished formulations upon request. The Prestwick2_000921 suppliers may include Prestwick2_000921 API manufacturers, exporters, distributors and traders.

click here to find a list of Prestwick2_000921 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Prestwick2_000921 USDMF

A Prestwick2_000921 DMF (Drug Master File) is a document detailing the whole manufacturing process of Prestwick2_000921 active pharmaceutical ingredient (API) in detail. Different forms of Prestwick2_000921 DMFs exist exist since differing nations have different regulations, such as Prestwick2_000921 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Prestwick2_000921 DMF submitted to regulatory agencies in the US is known as a USDMF. Prestwick2_000921 USDMF includes data on Prestwick2_000921's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prestwick2_000921 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Prestwick2_000921 suppliers with USDMF on PharmaCompass.

Prestwick2_000921 JDMF

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 Prestwick2_000921 Drug Master File in Japan (Prestwick2_000921 JDMF) empowers Prestwick2_000921 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 Prestwick2_000921 JDMF during the approval evaluation for pharmaceutical products. At the time of Prestwick2_000921 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 Prestwick2_000921 suppliers with JDMF on PharmaCompass.

Prestwick2_000921 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Prestwick2_000921 Drug Master File in Korea (Prestwick2_000921 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prestwick2_000921. The MFDS reviews the Prestwick2_000921 KDMF as part of the drug registration process and uses the information provided in the Prestwick2_000921 KDMF to evaluate the safety and efficacy of the drug.

After submitting a Prestwick2_000921 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 Prestwick2_000921 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Prestwick2_000921 suppliers with KDMF on PharmaCompass.

Prestwick2_000921 CEP

A Prestwick2_000921 CEP of the European Pharmacopoeia monograph is often referred to as a Prestwick2_000921 Certificate of Suitability (COS). The purpose of a Prestwick2_000921 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prestwick2_000921 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prestwick2_000921 to their clients by showing that a Prestwick2_000921 CEP has been issued for it. The manufacturer submits a Prestwick2_000921 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prestwick2_000921 CEP holder for the record. Additionally, the data presented in the Prestwick2_000921 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prestwick2_000921 DMF.

A Prestwick2_000921 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prestwick2_000921 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 Prestwick2_000921 suppliers with CEP (COS) on PharmaCompass.

Prestwick2_000921 WC

A Prestwick2_000921 written confirmation (Prestwick2_000921 WC) is an official document issued by a regulatory agency to a Prestwick2_000921 manufacturer, verifying that the manufacturing facility of a Prestwick2_000921 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prestwick2_000921 APIs or Prestwick2_000921 finished pharmaceutical products to another nation, regulatory agencies frequently require a Prestwick2_000921 WC (written confirmation) as part of the regulatory process.

click here to find a list of Prestwick2_000921 suppliers with Written Confirmation (WC) on PharmaCompass.

Prestwick2_000921 NDC

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 Prestwick2_000921 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Prestwick2_000921 API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Prestwick2_000921 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Prestwick2_000921 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prestwick2_000921 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Prestwick2_000921 suppliers with NDC on PharmaCompass.

Prestwick2_000921 GMP

Prestwick2_000921 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 Prestwick2_000921 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 Prestwick2_000921 GMP manufacturer or Prestwick2_000921 GMP API supplier for your needs.

Prestwick2_000921 CoA

A Prestwick2_000921 CoA (Certificate of Analysis) is a formal document that attests to Prestwick2_000921's compliance with Prestwick2_000921 specifications and serves as a tool for batch-level quality control.

Prestwick2_000921 CoA mostly includes findings from lab analyses of a specific batch. For each Prestwick2_000921 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.

Prestwick2_000921 may be tested according to a variety of international standards, such as European Pharmacopoeia (Prestwick2_000921 EP), Prestwick2_000921 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prestwick2_000921 USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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