Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Dr. Reddy's Laboratories
03 1Granules India Limited
04 1TAPI Technology & API Services
05 1Alembic Pharmaceuticals Limited
06 1Aurobindo Pharma Limited
07 1Beijing Huikang Boyuan Chemical Tech
08 1Biocon
09 1Centaur Pharmaceuticals
10 1Fuxin Long Rui Pharmaceutical
11 1Glenmark Life Sciences
12 1HEC Pharm
13 2HONOUR LAB LTD
14 1Harman Finochem
15 1Lee Pharma
16 1MSN Laboratories
17 1Macleods Pharmaceuticals Limited
18 2Morepen Laboratories
19 1Optimus Pharma
20 1Shanghai Wonder Pharmaceutical
21 1Sun Pharmaceutical Industries Limited
22 1Venkata Narayana Active Ingredients
23 1Viatris
24 1Viwit Pharmaceuticals Limited
25 1Viyash Life Sciences
26 1Wisdom Pharmaceutical
27 1Zhejiang Huahai Pharmaceutical
28 1Zydus Lifesciences
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-03
Pay. Date : 2017-11-15
DMF Number : 29844
Submission : 2015-09-25
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2015-04-14
Pay. Date : 2015-01-14
DMF Number : 28767
Submission : 2015-01-30
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-06
Pay. Date : 2024-01-08
DMF Number : 39130
Submission : 2024-01-14
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2015-04-20
Pay. Date : 2014-10-28
DMF Number : 28769
Submission : 2014-11-11
Status :
Type : II
A Linagliptin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Linagliptin, including repackagers and relabelers. The FDA regulates Linagliptin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Linagliptin 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 Linagliptin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Linagliptin supplier is an individual or a company that provides Linagliptin active pharmaceutical ingredient (API) or Linagliptin finished formulations upon request. The Linagliptin suppliers may include Linagliptin API manufacturers, exporters, distributors and traders.
click here to find a list of Linagliptin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Linagliptin DMF (Drug Master File) is a document detailing the whole manufacturing process of Linagliptin active pharmaceutical ingredient (API) in detail. Different forms of Linagliptin DMFs exist exist since differing nations have different regulations, such as Linagliptin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Linagliptin DMF submitted to regulatory agencies in the US is known as a USDMF. Linagliptin USDMF includes data on Linagliptin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Linagliptin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Linagliptin suppliers with USDMF on PharmaCompass.
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