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  • CAPSULE, DELAYED REL PELLETS;ORAL - 15MG
  • CAPSULE, DELAYED REL PELLETS;ORAL - 30MG
  • CAPSULE, DELAYED REL PELLETS;ORAL - 15MG
  • CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 103577-45-3 / Lansoprazole API manufacturers, exporters & distributors?

Lansoprazole manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Lansoprazole

Synonyms

103577-45-3, Prevacid, Agopton, Limpidex, Lanzor, Bamalite

Cas Number

103577-45-3

Unique Ingredient Identifier (UNII)

0K5C5T2QPG

About Lansoprazole

A 2,2,2-trifluoroethoxypyridyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. Lansoprazole is a racemic mixture of (R)- and (S)-isomers.

PREVACID NAPRAPAC 250 (COPACKAGED) Manufacturers

A PREVACID NAPRAPAC 250 (COPACKAGED) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PREVACID NAPRAPAC 250 (COPACKAGED), including repackagers and relabelers. The FDA regulates PREVACID NAPRAPAC 250 (COPACKAGED) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PREVACID NAPRAPAC 250 (COPACKAGED) 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 PREVACID NAPRAPAC 250 (COPACKAGED) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

PREVACID NAPRAPAC 250 (COPACKAGED) Suppliers

A PREVACID NAPRAPAC 250 (COPACKAGED) supplier is an individual or a company that provides PREVACID NAPRAPAC 250 (COPACKAGED) active pharmaceutical ingredient (API) or PREVACID NAPRAPAC 250 (COPACKAGED) finished formulations upon request. The PREVACID NAPRAPAC 250 (COPACKAGED) suppliers may include PREVACID NAPRAPAC 250 (COPACKAGED) API manufacturers, exporters, distributors and traders.

click here to find a list of PREVACID NAPRAPAC 250 (COPACKAGED) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

PREVACID NAPRAPAC 250 (COPACKAGED) USDMF

A PREVACID NAPRAPAC 250 (COPACKAGED) DMF (Drug Master File) is a document detailing the whole manufacturing process of PREVACID NAPRAPAC 250 (COPACKAGED) active pharmaceutical ingredient (API) in detail. Different forms of PREVACID NAPRAPAC 250 (COPACKAGED) DMFs exist exist since differing nations have different regulations, such as PREVACID NAPRAPAC 250 (COPACKAGED) USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A PREVACID NAPRAPAC 250 (COPACKAGED) DMF submitted to regulatory agencies in the US is known as a USDMF. PREVACID NAPRAPAC 250 (COPACKAGED) USDMF includes data on PREVACID NAPRAPAC 250 (COPACKAGED)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PREVACID NAPRAPAC 250 (COPACKAGED) USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of PREVACID NAPRAPAC 250 (COPACKAGED) suppliers with USDMF on PharmaCompass.

PREVACID NAPRAPAC 250 (COPACKAGED) 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 PREVACID NAPRAPAC 250 (COPACKAGED) Drug Master File in Japan (PREVACID NAPRAPAC 250 (COPACKAGED) JDMF) empowers PREVACID NAPRAPAC 250 (COPACKAGED) 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 PREVACID NAPRAPAC 250 (COPACKAGED) JDMF during the approval evaluation for pharmaceutical products. At the time of PREVACID NAPRAPAC 250 (COPACKAGED) 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 PREVACID NAPRAPAC 250 (COPACKAGED) suppliers with JDMF on PharmaCompass.

PREVACID NAPRAPAC 250 (COPACKAGED) KDMF

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

Pharmaceutical companies submit a PREVACID NAPRAPAC 250 (COPACKAGED) Drug Master File in Korea (PREVACID NAPRAPAC 250 (COPACKAGED) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of PREVACID NAPRAPAC 250 (COPACKAGED). The MFDS reviews the PREVACID NAPRAPAC 250 (COPACKAGED) KDMF as part of the drug registration process and uses the information provided in the PREVACID NAPRAPAC 250 (COPACKAGED) KDMF to evaluate the safety and efficacy of the drug.

After submitting a PREVACID NAPRAPAC 250 (COPACKAGED) 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 PREVACID NAPRAPAC 250 (COPACKAGED) API can apply through the Korea Drug Master File (KDMF).

click here to find a list of PREVACID NAPRAPAC 250 (COPACKAGED) suppliers with KDMF on PharmaCompass.

PREVACID NAPRAPAC 250 (COPACKAGED) CEP

A PREVACID NAPRAPAC 250 (COPACKAGED) CEP of the European Pharmacopoeia monograph is often referred to as a PREVACID NAPRAPAC 250 (COPACKAGED) Certificate of Suitability (COS). The purpose of a PREVACID NAPRAPAC 250 (COPACKAGED) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PREVACID NAPRAPAC 250 (COPACKAGED) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PREVACID NAPRAPAC 250 (COPACKAGED) to their clients by showing that a PREVACID NAPRAPAC 250 (COPACKAGED) CEP has been issued for it. The manufacturer submits a PREVACID NAPRAPAC 250 (COPACKAGED) CEP (COS) as part of the market authorization procedure, and it takes on the role of a PREVACID NAPRAPAC 250 (COPACKAGED) CEP holder for the record. Additionally, the data presented in the PREVACID NAPRAPAC 250 (COPACKAGED) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PREVACID NAPRAPAC 250 (COPACKAGED) DMF.

A PREVACID NAPRAPAC 250 (COPACKAGED) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PREVACID NAPRAPAC 250 (COPACKAGED) 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 PREVACID NAPRAPAC 250 (COPACKAGED) suppliers with CEP (COS) on PharmaCompass.

PREVACID NAPRAPAC 250 (COPACKAGED) WC

A PREVACID NAPRAPAC 250 (COPACKAGED) written confirmation (PREVACID NAPRAPAC 250 (COPACKAGED) WC) is an official document issued by a regulatory agency to a PREVACID NAPRAPAC 250 (COPACKAGED) manufacturer, verifying that the manufacturing facility of a PREVACID NAPRAPAC 250 (COPACKAGED) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting PREVACID NAPRAPAC 250 (COPACKAGED) APIs or PREVACID NAPRAPAC 250 (COPACKAGED) finished pharmaceutical products to another nation, regulatory agencies frequently require a PREVACID NAPRAPAC 250 (COPACKAGED) WC (written confirmation) as part of the regulatory process.

click here to find a list of PREVACID NAPRAPAC 250 (COPACKAGED) suppliers with Written Confirmation (WC) on PharmaCompass.

PREVACID NAPRAPAC 250 (COPACKAGED) 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 PREVACID NAPRAPAC 250 (COPACKAGED) as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for PREVACID NAPRAPAC 250 (COPACKAGED) 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 PREVACID NAPRAPAC 250 (COPACKAGED) 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 PREVACID NAPRAPAC 250 (COPACKAGED) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PREVACID NAPRAPAC 250 (COPACKAGED) NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of PREVACID NAPRAPAC 250 (COPACKAGED) suppliers with NDC on PharmaCompass.

PREVACID NAPRAPAC 250 (COPACKAGED) GMP

PREVACID NAPRAPAC 250 (COPACKAGED) 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 PREVACID NAPRAPAC 250 (COPACKAGED) 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 PREVACID NAPRAPAC 250 (COPACKAGED) GMP manufacturer or PREVACID NAPRAPAC 250 (COPACKAGED) GMP API supplier for your needs.

PREVACID NAPRAPAC 250 (COPACKAGED) CoA

A PREVACID NAPRAPAC 250 (COPACKAGED) CoA (Certificate of Analysis) is a formal document that attests to PREVACID NAPRAPAC 250 (COPACKAGED)'s compliance with PREVACID NAPRAPAC 250 (COPACKAGED) specifications and serves as a tool for batch-level quality control.

PREVACID NAPRAPAC 250 (COPACKAGED) CoA mostly includes findings from lab analyses of a specific batch. For each PREVACID NAPRAPAC 250 (COPACKAGED) 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.

PREVACID NAPRAPAC 250 (COPACKAGED) may be tested according to a variety of international standards, such as European Pharmacopoeia (PREVACID NAPRAPAC 250 (COPACKAGED) EP), PREVACID NAPRAPAC 250 (COPACKAGED) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PREVACID NAPRAPAC 250 (COPACKAGED) 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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