ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1LGM Pharma
04 1Bachem AG
05 1HRV Global Life Sciences
06 1USV Private Limited
07 1TAPI Technology & API Services
08 1Alembic Pharmaceuticals Limited
09 1AmbioPharm
10 1Auro Peptides Limited
11 1Aurobindo Pharma Limited
12 1Azico Biophore India Pvt. Ltd
13 1BCN Peptides
14 1Chengdu Shengnuo Biopharm
15 1Cipla
16 1Fresenius Kabi AB Brunna
17 1Guangzhou Tosun Pharmaceutical
18 1Hansoh Pharma
19 1MSN Laboratories
20 1Shenzhen JYMed Technology
21 1Smaart Pharmaceutticals
22 1Sun Pharmaceutical Industries Limited
23 1Tecoland Corporation
24 1Teva Pharmaceutical Industries
25 1Viatris
26 1Yonsung Fine Chemicals
01 4China
02 11India
03 2Israel
04 1South Korea
05 1Spain
06 1Sweden
07 1Switzerland
08 5U.S.A
01 15Active
02 11Blank
01 26Blank
01 1229MF10071
02 25Blank
01 1WC-0383A4
02 1WC-0404A3
03 24Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-21
Pay. Date : 2016-09-27
DMF Number : 30526
Submission : 2016-09-27
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20862
Submission : 2007-09-17
Status : Active
Type : II
Registration Number : 229MF10071
Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland
Initial Date of Registration : 2017-04-04
Latest Date of Registration : --
NDC Package Code : 55463-0033
Start Marketing Date : 2007-09-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-08
Pay. Date : 2018-12-03
DMF Number : 33212
Submission : 2018-12-07
Status : Active
Type : II
NDC Package Code : 62147-0277
Start Marketing Date : 2019-12-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-06
Pay. Date : 2016-04-28
DMF Number : 30476
Submission : 2016-06-09
Status : Active
Type : II
Available Reg Filing : CA |
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-04-30
Pay. Date : 2017-03-27
DMF Number : 31550
Submission : 2018-03-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-24
Pay. Date : 2018-08-13
DMF Number : 31260
Submission : 2016-12-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-06-19
Pay. Date : 2019-04-02
DMF Number : 33750
Submission : 2019-04-03
Status : Active
Type : II
A Icatibant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Icatibant, including repackagers and relabelers. The FDA regulates Icatibant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Icatibant 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 Icatibant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Icatibant supplier is an individual or a company that provides Icatibant active pharmaceutical ingredient (API) or Icatibant finished formulations upon request. The Icatibant suppliers may include Icatibant API manufacturers, exporters, distributors and traders.
click here to find a list of Icatibant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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