Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
01 1Supriya Lifescience
02 2Neuland Laboratories
03 1Amphastar Pharmaceuticals
04 1AstraZeneca
05 1Boehringer Ingelheim GmbH
06 2Cambrex Corporation
07 3Cipla
08 1FDC
09 2GSK
10 2Huhtamaki
11 1Laboratorio Chimico Internazionale Spa
12 1Lupin Ltd
13 1Lusochimica
14 1Melody Healthcare
15 1Olon S.p.A
16 1RP SCHERER GMBH & CO. KG
17 1Teva Pharmaceutical Industries
18 4Blank
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30708
Submission : 2016-06-27
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16104
Submission : 2002-08-16
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-26
Pay. Date : 2013-08-29
DMF Number : 16371
Submission : 2003-01-20
Status :
Type : II
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A COMBIVENT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of COMBIVENT, including repackagers and relabelers. The FDA regulates COMBIVENT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. COMBIVENT 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 COMBIVENT supplier is an individual or a company that provides COMBIVENT active pharmaceutical ingredient (API) or COMBIVENT finished formulations upon request. The COMBIVENT suppliers may include COMBIVENT API manufacturers, exporters, distributors and traders.
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A COMBIVENT DMF (Drug Master File) is a document detailing the whole manufacturing process of COMBIVENT active pharmaceutical ingredient (API) in detail. Different forms of COMBIVENT DMFs exist exist since differing nations have different regulations, such as COMBIVENT USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A COMBIVENT DMF submitted to regulatory agencies in the US is known as a USDMF. COMBIVENT USDMF includes data on COMBIVENT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The COMBIVENT USDMF is kept confidential to protect the manufacturer’s intellectual property.
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