01 1AbbVie Inc
02 1Neuland Laboratories
03 1TAPI Technology & API Services
04 1ALP Pharm
05 2Catalent Pharma Solutions
06 1Chongqing Huapont Pharmaceutical
07 1DISHMAN NETHERLANDS B.V.
08 1Formosa Laboratories
09 1Nanjing Heron Pharmaceutical
10 1Sai Life Sciences Limited
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24315
Submission : 2010-11-30
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23895
Submission : 2010-06-18
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 : 20865
Submission : 2007-09-19
Status :
Type : II
A Paricalcitol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Paricalcitol, including repackagers and relabelers. The FDA regulates Paricalcitol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Paricalcitol 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 Paricalcitol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Paricalcitol supplier is an individual or a company that provides Paricalcitol active pharmaceutical ingredient (API) or Paricalcitol finished formulations upon request. The Paricalcitol suppliers may include Paricalcitol API manufacturers, exporters, distributors and traders.
click here to find a list of Paricalcitol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Paricalcitol DMF (Drug Master File) is a document detailing the whole manufacturing process of Paricalcitol active pharmaceutical ingredient (API) in detail. Different forms of Paricalcitol DMFs exist exist since differing nations have different regulations, such as Paricalcitol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Paricalcitol DMF submitted to regulatory agencies in the US is known as a USDMF. Paricalcitol USDMF includes data on Paricalcitol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Paricalcitol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Paricalcitol suppliers with USDMF on PharmaCompass.
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