DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1TAPI Technology & API Services
03 2Apotex Pharmachem
04 1Catalent Pharma Solutions
05 1Everlight Chemical
06 1MSN Laboratories
07 1PHF SA
08 1R TECH UENO LTD
09 1Sun Pharmaceutical Industries Limited
10 1Yonsung Fine Chemicals
11 1Zhejiang Ausun Pharmaceutical
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-11
Pay. Date : 2013-12-19
DMF Number : 24705
Submission : 2011-03-29
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 : 23402
Submission : 2009-12-23
Status :
Type : II
A Lubiprostone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lubiprostone, including repackagers and relabelers. The FDA regulates Lubiprostone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lubiprostone 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 Lubiprostone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lubiprostone supplier is an individual or a company that provides Lubiprostone active pharmaceutical ingredient (API) or Lubiprostone finished formulations upon request. The Lubiprostone suppliers may include Lubiprostone API manufacturers, exporters, distributors and traders.
click here to find a list of Lubiprostone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lubiprostone DMF (Drug Master File) is a document detailing the whole manufacturing process of Lubiprostone active pharmaceutical ingredient (API) in detail. Different forms of Lubiprostone DMFs exist exist since differing nations have different regulations, such as Lubiprostone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lubiprostone DMF submitted to regulatory agencies in the US is known as a USDMF. Lubiprostone USDMF includes data on Lubiprostone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lubiprostone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lubiprostone suppliers with USDMF on PharmaCompass.
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