Inke S.A: APIs manufacturing plant.
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01 1Inke S.A
02 1Coral Drugs Private Limited
03 1Vamsi Labs
04 1Axplora
05 1LGM Pharma
06 1Fermion Oy
07 1Jai Radhe Sales
08 3Aarti Pharmalabs
09 1Gangwal Healthcare
10 1HRV Global Life Sciences
11 1TAPI Technology & API Services
12 2Amphastar Pharmaceuticals
13 1Aspire Lifesciences Pvt Ltd
14 1Astellas Pharma
15 1AstraZeneca
16 1Beijing Breathgreen Healthcare
17 1CHEMO
18 1Cipla
19 1DEAFARMA
20 1Fuan Pharmaceutical
21 1Guangzhou Tosun Pharmaceutical
22 1Harman Finochem
23 1Hasti Aria Shimi
24 3Industriale Chimica
25 1Jayco Chemical Industries
26 2Lusochimica
27 2MSN Laboratories
28 1Medisca
29 1Melody Healthcare Pvt Ltd
30 1Micro Orgo Chem
31 1Pcca
32 1ST Pharma
33 3Sicor
34 2Sicor Societa Italiana Corticosteroidi Srl
35 1Teva Pharmaceutical Industries
36 1Viatris
37 1Viyash Life Sciences
38 1Zhejiang Tiantai Pharmaceutical
39 1Blank
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01 4China
02 1Finland
03 1Germany
04 17India
05 1Iran
06 2Israel
07 11Italy
08 1Japan
09 1South Korea
10 2Spain
11 5U.S.A
12 2United Kingdom
13 1Blank
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01 11Active
02 4Inactive
03 34Blank
01 12Valid
02 2Withdrawn by Holder
03 35Blank
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01 1224MF10042
02 1227MF10062
03 1229MF10130
04 1229MF10159
05 45Blank
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01 1WC-0009
02 1WC-0021
03 1WC-0021n
04 1WC-0099
05 1WC-0144nA2
06 1WC-0155
07 1WC-0157
08 1WC-0227n
09 41Blank
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01 120120906-187-I-61-02
02 120121207-187-I-281-04
03 120130418-187-I-191-05
04 120130819-187-I-288-06
05 120150226-187-I-450-07
06 120150226-187-I-450-07(1)
07 120160310-187-I-468-08
08 120160310-187-I-468-08(1)
09 120160310-187-I-468-08(2)
10 120180420-187-I-540-09(1)-A
11 120180420-187-I-540-09(2)
12 120220926-187-I-648-10
13 37Blank
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01 112780-4880
02 114501-0087
03 138779-2295
04 143898-0130
05 143898-0131
06 146439-8763
07 149076-7001
08 151927-0216
09 252221-116
10 153104-7530
11 153183-0544
12 153183-2544
13 153183-7544
14 163190-0040
15 163190-0360
16 163190-0450
17 165015-771
18 166412-0204
19 182245-0113
20 29Blank
01 49Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-06-16
Pay. Date : 2017-05-10
DMF Number : 16628
Submission : 2003-06-03
Status : Active
Type : II
Certificate Number : R1-CEP 2006-024 - Rev 02
Issue Date : 2020-10-15
Type : Chemical
Substance Number : 1724
Status : Valid
Registration Number : 224MF10042
Registrant's Address : Area Industrial del Llobregat, C/Argent 1,08755 Castellbisbal Barcelona SPAIN
Initial Date of Registration : 2012-02-28
Latest Date of Registration :
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2013-08-19
Registration Number : 20130819-187-I-288-06
Manufacturer Name : INKE SA
Manufacturer Address : Argent,1, Area Industrial del Llobregat, Castellbisbal 08755 (Barcelona), Spain.
Available Reg Filing : CN |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30324
Submission : 2016-06-04
Status : Active
Type : II
Certificate Number : R1-CEP 2016-105 - Rev 00
Issue Date : 2022-09-28
Type : Chemical
Substance Number : 1724
Status : Valid
Date of Issue : 2022-09-16
Valid Till : 2025-07-05
Written Confirmation Number : WC-0009
Address of the Firm :
NDC Package Code : 49076-7001
Start Marketing Date : 2016-02-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
Certificate Number : R1-CEP 2006-227 - Rev 02
Issue Date : 2022-07-28
Type : Chemical
Substance Number : 1724
Status : Valid
Date of Issue : 2022-06-13
Valid Till : 2025-07-02
Written Confirmation Number : WC-0155
Address of the Firm :
NDC Package Code : 66412-0204
Start Marketing Date : 2023-09-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32936
Submission : 2018-07-27
Status : Active
Type : II
Certificate Number : R1-CEP 2010-132 - Rev 01
Issue Date : 2017-08-11
Type : Chemical
Substance Number : 1724
Status : Valid
NDC Package Code : 46439-8763
Start Marketing Date : 2018-06-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-19
Pay. Date : 2019-06-25
DMF Number : 33894
Submission : 2019-07-12
Status : Active
Type : II
Certificate Number : CEP 2015-215 - Rev 02
Issue Date : 2023-09-04
Type : Chemical
Substance Number : 1724
Status : Valid
Registration Number : 229MF10159
Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland
Initial Date of Registration : 2017-08-17
Latest Date of Registration :
NDC Package Code : 12780-4880
Start Marketing Date : 2016-01-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Certificate Number : R1-CEP 2013-220 - Rev 02
Issue Date : 2022-10-20
Type : Chemical
Substance Number : 1724
Status : Valid
Date of Issue : 2023-01-06
Valid Till : 2025-07-29
Written Confirmation Number : WC-0099
Address of the Firm :
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2018-10-24
Registration Number : 20160310-187-I-468-08(2)
Manufacturer Name : Aarti Industries Limited
Manufacturer Address : Unit-IV, Plot No. E-50, MIDC, Tarapur, TAL, Palghar, Dist Thane 401506, Maharashtra State, India
50
PharmaCompass offers a list of Formoterol Fumarate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Formoterol Fumarate manufacturer or Formoterol Fumarate supplier for your needs.
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A Dulera manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dulera, including repackagers and relabelers. The FDA regulates Dulera manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dulera 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 Dulera supplier is an individual or a company that provides Dulera active pharmaceutical ingredient (API) or Dulera finished formulations upon request. The Dulera suppliers may include Dulera API manufacturers, exporters, distributors and traders.
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We have 38 companies offering Dulera
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