Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
01 1Seqens
02 1Dr. Reddy's Laboratories
03 1Neuland Laboratories
04 1USV Private Limited
05 2TAPI Technology & API Services
06 1ALP Pharm
07 1Aurobindo Pharma Limited
08 2Catalent Pharma Solutions
09 1Cipla
10 1Emcure Pharmaceuticals
11 1Glenmark Pharmaceuticals
12 1Helsinn Advanced Synthesis
13 1Kyongbo Pharmaceutical Co., Ltd
14 1Lianyungang Runzhong Pharmaceutical Co Ltd
15 1MSN Laboratories
16 1Qilu Pharmaceutical
17 1RANBAXY LABORATORIES LIMITED
18 1Rolabo Outsourcing
19 1Tyche Industries Ltd
20 1Wockhardt
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-08
Pay. Date : 2013-01-16
DMF Number : 24798
Submission : 2011-03-23
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 : 23590
Submission : 2010-03-01
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21123
Submission : 2007-12-11
Status :
Type : II
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-17
Pay. Date : 2015-09-28
DMF Number : 28088
Submission : 2015-09-29
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21749
Submission : 2008-07-01
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-23
Pay. Date : 2012-11-09
DMF Number : 23332
Submission : 2009-12-03
Status :
Type : II
A Palonosetron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Palonosetron, including repackagers and relabelers. The FDA regulates Palonosetron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Palonosetron 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 Palonosetron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Palonosetron supplier is an individual or a company that provides Palonosetron active pharmaceutical ingredient (API) or Palonosetron finished formulations upon request. The Palonosetron suppliers may include Palonosetron API manufacturers, exporters, distributors and traders.
click here to find a list of Palonosetron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Palonosetron DMF (Drug Master File) is a document detailing the whole manufacturing process of Palonosetron active pharmaceutical ingredient (API) in detail. Different forms of Palonosetron DMFs exist exist since differing nations have different regulations, such as Palonosetron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Palonosetron DMF submitted to regulatory agencies in the US is known as a USDMF. Palonosetron USDMF includes data on Palonosetron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Palonosetron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Palonosetron suppliers with USDMF on PharmaCompass.
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