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API SUPPLIERS
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USDMF
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 : 35576
Submission : 2021-03-29
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Teneligliptin Hydrobromide Hydrate
Registration Number : 307MF10084
Registrant's Address : Flat No. 302, Bhanu Enclave, Sunder Nagar, Erragadda, Hyderabad - 500038, Telangana, ...
Initial Date of Registration : 2025-07-16
Latest Date of Registration : 2025-07-16
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
AMI Lifesciences is Driven by Chemistry. Powered by People.
Teneligliptin Hydrobromide Hydrate
Date of Issue : 2025-08-05
Valid Till : 2028-06-25
Written Confirmation Number : WC-0054
Address of the Firm : Block No. 82/B, ECP Road, At & Post Karakhadi, Tal - Padra, Dist. Baroda, Gujara...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Teneligliptin hydrochloride hydrate
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2025-02-28
Registration Number : Su289-28-ND
Manufacturer Name : Metrochem API Private Limite...
Manufacturer Address : Unit – IV, Plot No. 34B, 40B & 60B, JN Pharma City, Thanam(V), Parawada (M), Anakap...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Teneligliptin hydrobromide hydrate
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2025-01-24
Registration Number : Su289-27-ND
Manufacturer Name : Metrochem API Pvt Ltd, Unit-...
Manufacturer Address : Plot No. 34B, 40B & 60B, JN Pharma City, Thanam (V) Parawada (M), Anakapalli District...
AMI Lifesciences is Driven by Chemistry. Powered by People.
Teneligliptin hydrobromide hydrate
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2022-11-28
Registration Number : Su434-50-ND
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
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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...
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...
AMI Lifesciences is Driven by Chemistry. Powered by People.
Teneligliptin Hydrobromide Hydrate
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...
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...
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PharmaCompass offers a list of Teneligliptin Hydrobromide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Teneligliptin Hydrobromide manufacturer or Teneligliptin Hydrobromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Teneligliptin Hydrobromide manufacturer or Teneligliptin Hydrobromide supplier.
A Teneligliptin Hydrobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Teneligliptin Hydrobromide, including repackagers and relabelers. The FDA regulates Teneligliptin Hydrobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Teneligliptin Hydrobromide 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 Teneligliptin Hydrobromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Teneligliptin Hydrobromide supplier is an individual or a company that provides Teneligliptin Hydrobromide active pharmaceutical ingredient (API) or Teneligliptin Hydrobromide finished formulations upon request. The Teneligliptin Hydrobromide suppliers may include Teneligliptin Hydrobromide API manufacturers, exporters, distributors and traders.
click here to find a list of Teneligliptin Hydrobromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Teneligliptin Hydrobromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Teneligliptin Hydrobromide active pharmaceutical ingredient (API) in detail. Different forms of Teneligliptin Hydrobromide DMFs exist exist since differing nations have different regulations, such as Teneligliptin Hydrobromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Teneligliptin Hydrobromide DMF submitted to regulatory agencies in the US is known as a USDMF. Teneligliptin Hydrobromide USDMF includes data on Teneligliptin Hydrobromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Teneligliptin Hydrobromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Teneligliptin Hydrobromide 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 Teneligliptin Hydrobromide Drug Master File in Japan (Teneligliptin Hydrobromide JDMF) empowers Teneligliptin Hydrobromide 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 Teneligliptin Hydrobromide JDMF during the approval evaluation for pharmaceutical products. At the time of Teneligliptin Hydrobromide 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 Teneligliptin Hydrobromide 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 Teneligliptin Hydrobromide Drug Master File in Korea (Teneligliptin Hydrobromide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Teneligliptin Hydrobromide. The MFDS reviews the Teneligliptin Hydrobromide KDMF as part of the drug registration process and uses the information provided in the Teneligliptin Hydrobromide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Teneligliptin Hydrobromide 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 Teneligliptin Hydrobromide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Teneligliptin Hydrobromide suppliers with KDMF on PharmaCompass.
A Teneligliptin Hydrobromide written confirmation (Teneligliptin Hydrobromide WC) is an official document issued by a regulatory agency to a Teneligliptin Hydrobromide manufacturer, verifying that the manufacturing facility of a Teneligliptin Hydrobromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Teneligliptin Hydrobromide APIs or Teneligliptin Hydrobromide finished pharmaceutical products to another nation, regulatory agencies frequently require a Teneligliptin Hydrobromide WC (written confirmation) as part of the regulatory process.
click here to find a list of Teneligliptin Hydrobromide 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 Teneligliptin Hydrobromide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Teneligliptin Hydrobromide 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 Teneligliptin Hydrobromide 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 Teneligliptin Hydrobromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Teneligliptin Hydrobromide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Teneligliptin Hydrobromide suppliers with NDC on PharmaCompass.
Teneligliptin Hydrobromide 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 Teneligliptin Hydrobromide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Teneligliptin Hydrobromide GMP manufacturer or Teneligliptin Hydrobromide GMP API supplier for your needs.
A Teneligliptin Hydrobromide CoA (Certificate of Analysis) is a formal document that attests to Teneligliptin Hydrobromide's compliance with Teneligliptin Hydrobromide specifications and serves as a tool for batch-level quality control.
Teneligliptin Hydrobromide CoA mostly includes findings from lab analyses of a specific batch. For each Teneligliptin Hydrobromide 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.
Teneligliptin Hydrobromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Teneligliptin Hydrobromide EP), Teneligliptin Hydrobromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Teneligliptin Hydrobromide USP).
