LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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01 1LGM Pharma
02 1Transo-Pharm Handels GmbH
03 1Aspen API
04 1Deccan Nutraceuticals Pvt. Ltd
05 1HRV Global Life Sciences
06 1Medichem S.A
07 3Neuland Laboratories
08 1Tenatra Chemie
09 1TAPI Technology & API Services
10 1Angelini Pharma
11 1Aurobindo Pharma Limited
12 1Aurore Life Sciences
13 1Estechpharma
14 1Fujifilm Diosynth Biotechnologies
15 1Hetero Drugs
16 1KOLON Life Science, Inc
17 2Liaoyuan Pharmaceutical
18 2Maithri Drugs
19 1Medilux Laboratories
20 2Megafine Pharma (P) Limited
21 1Micro Labs Limited
22 1Nifty Labs
23 1Ramdev Chemicals Pvt Ltd
24 1Sato Yakuhin Kogyo Co., Ltd
25 1Sms Lifesciences
26 1Sumitomo Chemical
27 1Sun Pharmaceutical Industries Limited
28 1Suzhou Hengyi Pharmaceutical
29 1Syn-Tech Chem. & Pharm
30 1Teva Pharmaceutical Industries
31 3Tianish Laboratories
32 2Viatris
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01 3China
02 1Germany
03 22India
04 2Israel
05 1Italy
06 2Japan
07 1Netherlands
08 2South Korea
09 1Spain
10 1Taiwan
11 3U.S.A
12 1United Kingdom
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01 16Active
02 4Inactive
03 20Blank
01 15Valid
02 25Blank
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01 1219MF10237
02 1229MF10101
03 1229MF10107
04 1229MF10115
05 1229MF10154
06 1229MF10155
07 1230MF10113
08 1301MF10005
09 32Blank
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01 1TFDA-0002291
02 2WC-0016A2
03 1WC-0036
04 1WC-0037
05 1WC-0040A3
06 1WC-0087-(Annexure-1)
07 1WC-0119
08 1WC-0120
09 1WC-0168
10 1WC-0407
11 29Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Date of Issue : 2022-02-22
Valid Till : 2025-07-15
Written Confirmation Number : TFDA-0002291
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10457
Submission : 1993-08-30
Status : Active
Type : II
Certificate Number : R1-CEP 2010-016 - Rev 03
Issue Date : 2022-12-15
Type : Chemical
Substance Number : 2338
Status : Valid
Registration Number : 219MF10237
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2007-07-17
Latest Date of Registration :
NDC Package Code : 60870-0117
Start Marketing Date : 2008-07-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Synex Co., Ltd.
Registration Date : 2022-01-12
Registration Number : 20220112-209-J-1207
Manufacturer Name : Aspen Oss BV
Manufacturer Address : Veersemeer 4, 5347 JN Oss, The Netherlands
Available Reg Filing : ASMF, CN |
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-04-30
Pay. Date : 2013-04-17
DMF Number : 15749
Submission : 2001-12-05
Status : Active
Type : II
Certificate Number : R1-CEP 2007-178 - Rev 00
Issue Date : 2013-09-05
Type : Chemical
Substance Number : 2338
Status : Valid
NDC Package Code : 53296-0047
Start Marketing Date : 2010-05-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2022-02-04
Registration Number : 20220204-209-J-1227
Manufacturer Name : MEDICHEM SA
Manufacturer Address : Pirineus street, 127, Poligon Industrial de Celra, 17460 Celra (Girona), Spain
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16007
Submission : 2002-06-11
Status : Active
Type : II
Certificate Number : R1-CEP 2008-243 - Rev 05
Issue Date : 2022-12-19
Type : Chemical
Substance Number : 2338
Status : Valid
Registration Number : 301MF10005
Registrant's Address : 11th Floor (5th Office Level), Phoenix IVY Building, Plot No. 573A-Ⅲ, Road No. 82, Jubilee Hills,Hyderabad-33 Telangana, India
Initial Date of Registration : 2019-05-15
Latest Date of Registration :
Date of Issue : 2022-07-28
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
NDC Package Code : 58032-0121
Start Marketing Date : 2017-12-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Medipoem Co., Ltd.
Registration Date : 2024-01-12
Registration Number : 20201022-209-J-571(3)
Manufacturer Name : Neuland Laboratories Limited
Manufacturer Address : Unit-I, Sy. No. 347,473,474, 490/2, Bonthapally Village, Veerabhadraswamy Temple road, Gummadidala Mandal, Sangareddy District-502 313, Telangana State, India
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15323
Submission : 2001-03-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24022
Submission : 2010-08-04
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-06-16
Written Confirmation Number : WC-0037
Address of the Firm :
NDC Package Code : 58032-0121
Start Marketing Date : 2017-12-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Medipoem Co., Ltd.
Registration Date : 2024-01-12
Registration Number : 20201022-209-J-571(3)
Manufacturer Name : Neuland Laboratories Limited
Manufacturer Address : Unit-I, Sy. No. 347,473,474, 490/2, Bonthapally Village, Veerabhadraswamy Temple road, Gummadidala Mandal, Sangareddy District-502 313, Telangana State, India
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A Mirtabene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirtabene, including repackagers and relabelers. The FDA regulates Mirtabene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirtabene 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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