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 1USV Private Limited
04 1TAPI Technology & API Services
05 1Chemi SpA
06 1Cipla
07 1Emcure Pharmaceuticals
08 1Gador SA
09 1Hetero Drugs
10 1Hikma Pharmaceuticals
11 1Ipca Laboratories
12 1Jubilant Generics
13 1Lianyungang Runzhong Pharmaceutical Co Ltd
14 2Lunan Pharmaceutical
15 1Maprimed
16 1Natco Pharma
17 1Pisgah Labs
18 1ScinoPharm Taiwan, Ltd
19 1Shilpa Medicare
20 1Sun Pharmaceutical Industries Limited
21 1Trifarma
22 1Viatris
23 1Wockhardt
24 1Yung Shin Pharmaceutical Industrial
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-03
Pay. Date : 2015-08-27
DMF Number : 24306
Submission : 2010-10-13
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21344
Submission : 2008-02-18
Status :
Type : II
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-15
Pay. Date : 2013-01-28
DMF Number : 24469
Submission : 2010-12-24
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 19701
Submission : 2006-08-22
Status :
Type : II
A Zoledronic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zoledronic Acid, including repackagers and relabelers. The FDA regulates Zoledronic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zoledronic Acid 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 Zoledronic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zoledronic Acid supplier is an individual or a company that provides Zoledronic Acid active pharmaceutical ingredient (API) or Zoledronic Acid finished formulations upon request. The Zoledronic Acid suppliers may include Zoledronic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Zoledronic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zoledronic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Zoledronic Acid active pharmaceutical ingredient (API) in detail. Different forms of Zoledronic Acid DMFs exist exist since differing nations have different regulations, such as Zoledronic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zoledronic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Zoledronic Acid USDMF includes data on Zoledronic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zoledronic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zoledronic Acid suppliers with USDMF on PharmaCompass.
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