Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Dr. Reddy's Laboratories
03 1TAPI Technology & API Services
04 1Cadila Pharmaceuticals
05 1Hikal
06 1Ipca Laboratories
07 1Qilu Pharmaceutical
08 1Sun Pharmaceutical Industries Limited
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16172
Submission : 2002-09-30
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 : 16320
Submission : 2003-01-29
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16644
Submission : 2003-06-11
Status :
Type : II
A Ondansetron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ondansetron, including repackagers and relabelers. The FDA regulates Ondansetron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ondansetron 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 Ondansetron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ondansetron supplier is an individual or a company that provides Ondansetron active pharmaceutical ingredient (API) or Ondansetron finished formulations upon request. The Ondansetron suppliers may include Ondansetron API manufacturers, exporters, distributors and traders.
click here to find a list of Ondansetron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ondansetron DMF (Drug Master File) is a document detailing the whole manufacturing process of Ondansetron active pharmaceutical ingredient (API) in detail. Different forms of Ondansetron DMFs exist exist since differing nations have different regulations, such as Ondansetron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ondansetron DMF submitted to regulatory agencies in the US is known as a USDMF. Ondansetron USDMF includes data on Ondansetron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ondansetron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ondansetron suppliers with USDMF on PharmaCompass.
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