Aspen API. More than just an API.
01 1Aspen API
02 1Medichem S.A
03 1Alembic Pharmaceuticals Limited
04 1CHEMO IBERICA SA
05 1Hisamitsu Pharmaceutical Co., Inc.
06 1Lupin Ltd
07 2MSN Laboratories
08 1Megafine Pharma (P) Limited
09 1Olon S.p.A
10 1Sigmapharm Laboratories, LLC
11 1Signa S.A. de C.V.
12 1Sun Pharmaceutical Industries Limited
13 1Viatris
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34868
Submission : 2020-06-10
Status :
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-01
Pay. Date : 2013-05-01
DMF Number : 26923
Submission : 2013-05-16
Status :
Type : II
A Asenapine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Asenapine Maleate, including repackagers and relabelers. The FDA regulates Asenapine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Asenapine Maleate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Asenapine Maleate supplier is an individual or a company that provides Asenapine Maleate active pharmaceutical ingredient (API) or Asenapine Maleate finished formulations upon request. The Asenapine Maleate suppliers may include Asenapine Maleate API manufacturers, exporters, distributors and traders.
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A Asenapine Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Asenapine Maleate active pharmaceutical ingredient (API) in detail. Different forms of Asenapine Maleate DMFs exist exist since differing nations have different regulations, such as Asenapine Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Asenapine Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Asenapine Maleate USDMF includes data on Asenapine Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Asenapine Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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