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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
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AMI Lifesciences is Driven by Chemistry. Powered by People.
Tenegliptin Hydrobromide Hydrate
Date of Issue : 2022-08-18
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm : Block No. 82/B, ECP Road, At & Post. Karakhadi, Tal-Padra,City Karakhadi -391450...
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 : 289-28-ND
Manufacturer Name : Metrochem API Private Limite...
Manufacturer Address : Unit – IV, Plot No. 34B, 40B & 60B, JN Pharma City, Thanam(V), Parawada (M), Anakap...
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...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Teneligliptin hydrobromide hydrate
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2023-01-04
Registration Number : 173-44-ND
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Sy no. 10/G-1, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Teneligliptin hydrochloride hydrate
Registrant Name : Klasia Co., Ltd.
Registration Date : 2020-02-27
Registration Number : No. 758-4-ND
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No. 10/G1, Gaddapotharam Village, Jinnaram Mandal, Sangareddy Telangana State,...
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ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & novel modalities with ICH-grade quality.
CAS Number : 401566-79-8
End Use API : Teneligliptin Hydrobromide
About The Company : ChemExpress is a leading CRO and CDMO partner supporting pharmaceutical and biotech companies worldwide. We specialize in small molecules, biologics, and next-g...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & novel modalities with ICH-grade quality.
CAS Number : 401564-36-1
End Use API : Teneligliptin Hydrobromide
About The Company : ChemExpress is a leading CRO and CDMO partner supporting pharmaceutical and biotech companies worldwide. We specialize in small molecules, biologics, and next-g...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
trans-N-Boc-4-hydroxy-L-proline
CAS Number : 13726-69-7
End Use API : Teneligliptin Hydrobromide
About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
CAS Number : 13726-69-7
End Use API : Teneligliptin Hydrobromide
About The Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipi...
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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, Price,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.
PharmaCompass also assists you with knowing the Teneligliptin Hydrobromide API Price utilized in the formulation of products. Teneligliptin Hydrobromide API Price is not always fixed or binding as the Teneligliptin Hydrobromide Price is obtained through a variety of data sources. The Teneligliptin Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Teneligliptin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Teneligliptin, including repackagers and relabelers. The FDA regulates Teneligliptin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Teneligliptin 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Teneligliptin supplier is an individual or a company that provides Teneligliptin active pharmaceutical ingredient (API) or Teneligliptin finished formulations upon request. The Teneligliptin suppliers may include Teneligliptin API manufacturers, exporters, distributors and traders.
click here to find a list of Teneligliptin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Teneligliptin DMF (Drug Master File) is a document detailing the whole manufacturing process of Teneligliptin active pharmaceutical ingredient (API) in detail. Different forms of Teneligliptin DMFs exist exist since differing nations have different regulations, such as Teneligliptin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Teneligliptin DMF submitted to regulatory agencies in the US is known as a USDMF. Teneligliptin USDMF includes data on Teneligliptin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Teneligliptin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Teneligliptin 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 Teneligliptin Drug Master File in Korea (Teneligliptin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Teneligliptin. The MFDS reviews the Teneligliptin KDMF as part of the drug registration process and uses the information provided in the Teneligliptin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Teneligliptin 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Teneligliptin suppliers with KDMF on PharmaCompass.
A Teneligliptin written confirmation (Teneligliptin WC) is an official document issued by a regulatory agency to a Teneligliptin manufacturer, verifying that the manufacturing facility of a Teneligliptin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Teneligliptin APIs or Teneligliptin finished pharmaceutical products to another nation, regulatory agencies frequently require a Teneligliptin WC (written confirmation) as part of the regulatory process.
click here to find a list of Teneligliptin 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Teneligliptin 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Teneligliptin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Teneligliptin suppliers with NDC on PharmaCompass.
Teneligliptin 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 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 Teneligliptin GMP manufacturer or Teneligliptin GMP API supplier for your needs.
A Teneligliptin CoA (Certificate of Analysis) is a formal document that attests to Teneligliptin's compliance with Teneligliptin specifications and serves as a tool for batch-level quality control.
Teneligliptin CoA mostly includes findings from lab analyses of a specific batch. For each Teneligliptin 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Teneligliptin EP), Teneligliptin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Teneligliptin USP).
