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CEP/COS
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JDMF
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VMF
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USP
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JP
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FDF Dossiers
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Europe
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FDF
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API SUPPLIERS
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USDMF
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40643
Submission : 2024-10-07
Status :
Type : II
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43136
Submission : 2025-11-26
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38991
Submission : 2023-12-30
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Kyungdong Pharmaceutical Co., Ltd.
Registration Date : 2024-01-19
Registration Number : Su69-17-ND(1)
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Iksoo Pharmaceutical Co., Ltd.
Registration Date : 2023-08-18
Registration Number : Su69-17-ND
Manufacturer Name : Ami Lifesciences Pvt. Ltd.
Manufacturer Address : Block No. 82/B, ECP Road, At & Post: Karakhadi-391450, Taluka: Padra, District : Vado...
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AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory thera...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
About the Company : Founded in 2006, ChemExpress provides CRO and CDMO services to pharmaceutical and biotech companies. The company supports small molecules, biologics, and new modalities such as ADC...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
About the Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-growth therapeutic ar...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Neuland Laboratories- A dedicated 100% API provider.
About the Company : Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compound...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and trusted manufacturer of specialty chemicals and ingredients, with seven world-class facilities meeting global safety and quality standards. Thro...
Maithri Drugs: Dedicated to your API needs.
About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...
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API Imports and Exports
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PharmaCompass offers a list of Tegoprazan 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 Tegoprazan manufacturer or Tegoprazan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tegoprazan manufacturer or Tegoprazan supplier.
PharmaCompass also assists you with knowing the Tegoprazan API Price utilized in the formulation of products. Tegoprazan API Price is not always fixed or binding as the Tegoprazan Price is obtained through a variety of data sources. The Tegoprazan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A CJ-12420 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CJ-12420, including repackagers and relabelers. The FDA regulates CJ-12420 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CJ-12420 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 CJ-12420 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CJ-12420 supplier is an individual or a company that provides CJ-12420 active pharmaceutical ingredient (API) or CJ-12420 finished formulations upon request. The CJ-12420 suppliers may include CJ-12420 API manufacturers, exporters, distributors and traders.
click here to find a list of CJ-12420 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CJ-12420 DMF (Drug Master File) is a document detailing the whole manufacturing process of CJ-12420 active pharmaceutical ingredient (API) in detail. Different forms of CJ-12420 DMFs exist exist since differing nations have different regulations, such as CJ-12420 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CJ-12420 DMF submitted to regulatory agencies in the US is known as a USDMF. CJ-12420 USDMF includes data on CJ-12420's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CJ-12420 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CJ-12420 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 CJ-12420 Drug Master File in Korea (CJ-12420 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CJ-12420. The MFDS reviews the CJ-12420 KDMF as part of the drug registration process and uses the information provided in the CJ-12420 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CJ-12420 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 CJ-12420 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CJ-12420 suppliers with KDMF 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 CJ-12420 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for CJ-12420 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 CJ-12420 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 CJ-12420 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CJ-12420 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of CJ-12420 suppliers with NDC on PharmaCompass.
CJ-12420 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 CJ-12420 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 CJ-12420 GMP manufacturer or CJ-12420 GMP API supplier for your needs.
A CJ-12420 CoA (Certificate of Analysis) is a formal document that attests to CJ-12420's compliance with CJ-12420 specifications and serves as a tool for batch-level quality control.
CJ-12420 CoA mostly includes findings from lab analyses of a specific batch. For each CJ-12420 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.
CJ-12420 may be tested according to a variety of international standards, such as European Pharmacopoeia (CJ-12420 EP), CJ-12420 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CJ-12420 USP).
