DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Polpharma
03 2Biocon
04 1Hikal
05 1Zhejiang Jingsheng Pharmaceutical
01 2SITAGLIPTIN HYDROCHLORIDE
02 1SITAGLIPTIN HYDROCHLORIDE (ENZYMATIC)
03 1SITAGLIPTIN HYDROCHLORIDE (MONOHYDRATE)
04 1SITAGLIPTIN HYDROCHLORIDE (PROCESS B)
05 1SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE
01 1China
02 4India
03 1Poland
01 6Active
01 3Complete
02 3Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-18
Pay. Date : 2020-09-16
DMF Number : 34400
Submission : 2019-12-30
Status : Active
Type : II
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36129
Submission : 2021-07-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-11
Pay. Date : 2024-03-21
DMF Number : 37684
Submission : 2024-03-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-02
Pay. Date : 2022-01-20
DMF Number : 36558
Submission : 2022-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37288
Submission : 2022-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39440
Submission : 2024-01-27
Status : Active
Type : II
A Sitagliptin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sitagliptin Hydrochloride, including repackagers and relabelers. The FDA regulates Sitagliptin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sitagliptin Hydrochloride 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 Sitagliptin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sitagliptin Hydrochloride supplier is an individual or a company that provides Sitagliptin Hydrochloride active pharmaceutical ingredient (API) or Sitagliptin Hydrochloride finished formulations upon request. The Sitagliptin Hydrochloride suppliers may include Sitagliptin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Sitagliptin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sitagliptin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Sitagliptin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Sitagliptin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Sitagliptin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sitagliptin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Sitagliptin Hydrochloride USDMF includes data on Sitagliptin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sitagliptin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sitagliptin Hydrochloride suppliers with USDMF on PharmaCompass.
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