Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Seqens
03 1AKSHAT PHARMA PRIVATE LTD
04 1Amsa Spa
05 1Aurobindo Pharma Limited
06 1BIOFIRST PHARMACEUTICALS LLC
07 1Boehringer Ingelheim GmbH
08 1Breathgreen Pharmaceuticals
09 1CSL Vifor
10 1Endo International
11 1Hainan Poly Pharm
12 1Harman Finochem
13 1Hikma Pharmaceuticals
14 1Hovione
15 1Melody Healthcare Pvt Ltd
16 1Nishchem International Pvt. Ltd
17 1Resonance Laboratories Pvt. Ltd
18 1Siegfried AG
19 1Sifavitor srl
20 1Suven Life Sciences Limited
21 1Swati Spentose
22 1Tai Heng Industry Co., Ltd
23 1Viyash Life Sciences
01 9GLYCOPYRROLATE
02 1GLYCOPYRROLATE INHALATION GRADE
03 9GLYCOPYRROLATE USP
04 1GLYCOPYRROLATE USP, NON-STERILE DRUG SUBSTANCE
05 1GLYCOPYRRONIUM BROMIDE
06 1GLYCOPYRRONIUM BROMIDE (MICRONIZED AND NON-MICRONIZED)
07 1VIT-45 POWDER
01 2China
02 1France
03 1Germany
04 9India
05 1Ireland
06 2Italy
07 1Portugal
08 1Spain
09 2Switzerland
10 2U.S.A
11 1United Kingdom
01 18Active
02 5Inactive
01 8Complete
02 15Blank
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-16
Pay. Date : 2017-07-06
DMF Number : 31836
Submission : 2017-07-22
Status : Active
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-05
Pay. Date : 2013-09-30
DMF Number : 18106
Submission : 2005-02-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19026
Submission : 2005-12-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-13
Pay. Date : 2015-03-06
DMF Number : 16972
Submission : 2003-11-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16967
Submission : 2003-11-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-12-06
DMF Number : 19710
Submission : 2006-08-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18727
Submission : 2005-08-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26470
Submission : 2012-09-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-27
Pay. Date : 2018-04-24
DMF Number : 29990
Submission : 2015-11-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21326
Submission : 2008-02-07
Status : Active
Type : II
A Glycopyrrolate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glycopyrrolate, including repackagers and relabelers. The FDA regulates Glycopyrrolate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glycopyrrolate 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 Glycopyrrolate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glycopyrrolate supplier is an individual or a company that provides Glycopyrrolate active pharmaceutical ingredient (API) or Glycopyrrolate finished formulations upon request. The Glycopyrrolate suppliers may include Glycopyrrolate API manufacturers, exporters, distributors and traders.
click here to find a list of Glycopyrrolate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glycopyrrolate DMF (Drug Master File) is a document detailing the whole manufacturing process of Glycopyrrolate active pharmaceutical ingredient (API) in detail. Different forms of Glycopyrrolate DMFs exist exist since differing nations have different regulations, such as Glycopyrrolate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glycopyrrolate DMF submitted to regulatory agencies in the US is known as a USDMF. Glycopyrrolate USDMF includes data on Glycopyrrolate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glycopyrrolate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glycopyrrolate suppliers with USDMF on PharmaCompass.
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