Aspen API. More than just an API.
01 1Aspen API
02 1Dr. Reddy's Laboratories
03 1Apothecon Pharmaceuticals
04 1Arch Pharmalabs
05 1Curia
06 1Escientia
07 1Harman Finochem
08 1Kalintis Healthcare
Aspen API. More than just an API.
GDUFA
DMF Review : Complete
Rev. Date : 2012-10-25
Pay. Date : 2012-12-19
DMF Number : 6914
Submission : 1987-04-09
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2021-04-02
Pay. Date : 2021-03-30
DMF Number : 7033
Submission : 1987-06-18
Status :
Type : II
A Benztropine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benztropine, including repackagers and relabelers. The FDA regulates Benztropine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benztropine 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 Benztropine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benztropine supplier is an individual or a company that provides Benztropine active pharmaceutical ingredient (API) or Benztropine finished formulations upon request. The Benztropine suppliers may include Benztropine API manufacturers, exporters, distributors and traders.
click here to find a list of Benztropine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benztropine DMF (Drug Master File) is a document detailing the whole manufacturing process of Benztropine active pharmaceutical ingredient (API) in detail. Different forms of Benztropine DMFs exist exist since differing nations have different regulations, such as Benztropine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benztropine DMF submitted to regulatory agencies in the US is known as a USDMF. Benztropine USDMF includes data on Benztropine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benztropine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benztropine suppliers with USDMF on PharmaCompass.
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