TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
01 1TAPI Technology & API Services
02 1Alembic Pharmaceuticals Limited
03 1Aurobindo Pharma Limited
04 1HONOUR LAB LTD
05 1Laurus Labs
06 1MSN Laboratories
07 1Raks Pharma
08 1Seasons Biotechnology
09 1Viatris
10 1Zhejiang Guobang Pharmaceutical
11 1Zhejiang Huayi Pharmaceutical Co., Ltd.
12 1Zydus Lifesciences
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-03
Pay. Date : 2017-02-22
DMF Number : 31416
Submission : 2017-04-13
Status :
Type : II
A Macitentan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Macitentan, including repackagers and relabelers. The FDA regulates Macitentan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Macitentan 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 Macitentan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Macitentan supplier is an individual or a company that provides Macitentan active pharmaceutical ingredient (API) or Macitentan finished formulations upon request. The Macitentan suppliers may include Macitentan API manufacturers, exporters, distributors and traders.
click here to find a list of Macitentan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Macitentan DMF (Drug Master File) is a document detailing the whole manufacturing process of Macitentan active pharmaceutical ingredient (API) in detail. Different forms of Macitentan DMFs exist exist since differing nations have different regulations, such as Macitentan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Macitentan DMF submitted to regulatory agencies in the US is known as a USDMF. Macitentan USDMF includes data on Macitentan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Macitentan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Macitentan suppliers with USDMF on PharmaCompass.
We have 12 companies offering Macitentan
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
