Minakem is manufacturing small molecules APIs including corticosteroids
01 1Minakem (formerly Delmar Chemicals)
02 1Dr. Reddy's Laboratories
03 2TAPI Technology & API Services
04 1Apotex Pharmachem
05 1Aurobindo Pharma Limited
06 1China Gateway Pharmaceutical Co Ltd
07 1Cipla
08 1Formosa Laboratories
09 1Hetero Drugs
10 1LG Life Sciences
11 1Laurus Labs
12 1Linhai Huanan Chemicals Co., Ltd.
13 1Lunan Pharmaceutical
14 3MSN Laboratories
15 1Macleods Pharmaceuticals Limited
16 1Melody Healthcare Pvt Ltd
17 1Morepen Laboratories
18 1SINTENOVO, S.A. DE C.V.
19 1Sun Pharmaceutical Industries Limited
20 1Torrent Pharmaceuticals Limited
21 1Unichem Laboratories Limited
22 5Unimark Remedies Limited
23 1Viatris
24 1Zenfold Sustainable Technologies
25 2Zhejiang Tianyu Pharmaceutical Co., Ltd
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16243
Submission : 2002-11-15
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-18
Pay. Date : 2012-12-31
DMF Number : 24516
Submission : 2010-12-31
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19829
Submission : 2006-10-04
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-20
Pay. Date : 2017-02-22
DMF Number : 31413
Submission : 2017-05-09
Status :
Type : II
A Montelukast Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Montelukast Sodium, including repackagers and relabelers. The FDA regulates Montelukast Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Montelukast Sodium 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 Montelukast Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Montelukast Sodium supplier is an individual or a company that provides Montelukast Sodium active pharmaceutical ingredient (API) or Montelukast Sodium finished formulations upon request. The Montelukast Sodium suppliers may include Montelukast Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Montelukast Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Montelukast Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Montelukast Sodium active pharmaceutical ingredient (API) in detail. Different forms of Montelukast Sodium DMFs exist exist since differing nations have different regulations, such as Montelukast Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Montelukast Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Montelukast Sodium USDMF includes data on Montelukast Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Montelukast Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Montelukast Sodium suppliers with USDMF on PharmaCompass.
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