Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem
02 1Coral Drugs Private Limited
03 2Axplora
04 1Aspen API
05 1Aarti Pharmalabs
06 2TAPI Technology & API Services
07 1Amphastar Pharmaceuticals
08 1Apotex Pharmachem
09 1AstraZeneca
10 2Breathgreen Pharmaceuticals
11 1Cipla
12 2Curia
13 1Henan Lihua Pharmaceutical
14 1Hubei Gedian Humanwell Pharmaceutical
15 2Industriale Chimica
16 1NEWCHEM SPA
17 1Sterling Spa
18 1Sun Pharmaceutical Industries Limited
19 1Tianjin Tianyao Pharmaceuticals Co., Ltd.
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-03
Pay. Date : 2017-02-10
DMF Number : 28441
Submission : 2014-06-20
Status :
Type : II
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30534
Submission : 2017-02-02
Status :
Type : II
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-16
Pay. Date : 2013-05-03
DMF Number : 18910
Submission : 2005-10-26
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10493
Submission : 1993-09-23
Status :
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-03
Pay. Date : 2013-03-04
DMF Number : 20609
Submission : 2007-06-13
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-29
Pay. Date : 2012-11-13
DMF Number : 10976
Submission : 1994-07-11
Status :
Type : II
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25615
Submission : 2011-12-20
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-30
Pay. Date : 2012-11-13
DMF Number : 16932
Submission : 2003-10-28
Status :
Type : II
A Symbicort manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Symbicort, including repackagers and relabelers. The FDA regulates Symbicort manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Symbicort 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 Symbicort manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Symbicort supplier is an individual or a company that provides Symbicort active pharmaceutical ingredient (API) or Symbicort finished formulations upon request. The Symbicort suppliers may include Symbicort API manufacturers, exporters, distributors and traders.
click here to find a list of Symbicort suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Symbicort DMF (Drug Master File) is a document detailing the whole manufacturing process of Symbicort active pharmaceutical ingredient (API) in detail. Different forms of Symbicort DMFs exist exist since differing nations have different regulations, such as Symbicort USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Symbicort DMF submitted to regulatory agencies in the US is known as a USDMF. Symbicort USDMF includes data on Symbicort's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Symbicort USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Symbicort suppliers with USDMF on PharmaCompass.
We have 19 companies offering Symbicort
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