Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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01 1FARMAK, a.s
02 1Enaltec Labs
03 1LGM Pharma
04 1Jai Radhe Sales
05 1Bhavna Laboratories
06 1Tenatra Exports
07 1Zeon Pharma Industries India Pvt Ltd
08 1Maithri Drugs
09 1Arde’s Laboratories
10 1Ax Pharmaceutical Corporation
11 2C-Squared Pharma
12 1CARBOGEN AMCIS AG
13 1Centaur Pharmaceuticals
14 1Darmerica
15 1Darou Pakhsh Pharma Chem
16 1FDC
17 1Flax Laboratories
18 1Guangzhou Tosun Pharmaceutical
19 1Hunan Huateng Pharmaceutical Co ltd
20 1Ind Swift Laboratories Limited
21 1Indoco Remedies Limited
22 2Laurus Labs
23 1Lupin Ltd
24 3Medichem S.A
25 1Micro Labs Limited
26 1Panchsheel Organics
27 2Pcca
28 1Piramal Enterprises Limited
29 1Piramal Pharma Solutions
30 1SNA Healthcare
31 1Sanwa Chemical Industrial
32 1Symed Labs
33 1Unichem Laboratories Limited
34 1Unipex
35 1Viyash Life Sciences
36 1Blank
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01 1Canada
02 2China
03 1Czech Republic
04 1France
05 1Hong Kong
06 22India
07 1Iran
08 2Ireland
09 3Spain
10 1Switzerland
11 3U.S.A
12 2United Kingdom
13 1Blank
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01 11Active
02 1Inactive
03 29Blank
01 10Valid
02 31Blank
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01 1222MF10073
02 1301MF10101
03 1301MF10111
04 1302MF10029
05 37Blank
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01 1WC-0055
02 1WC-0063
03 1WC-0072
04 1WC-0107
05 1WC-0123
06 1WC-0152
07 1WC-0177
08 1WC-0225
09 1WC-0407
10 1WC-0544
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01 120120713-200-I-93-01
02 120131220-200-I-380-02
03 120140924-200-I-402-03
04 120141201-200-I-451-04
05 120141201-200-I-451-04(1)
06 120141201-200-I-451-04(2)
07 120141203-200-I-427-05
08 120151229-200-I-471-06(1)-A
09 120230116-200-I-647-07
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01 114445-003
02 142385-038
03 142385-750
04 142571-354
05 151927-0063
06 151927-0372
07 153296-0050
08 153747-036
09 155545-0668
10 155679-133
11 158567-100
12 163278-0488
13 164181-0020
14 165085-0030
15 166022-0110
16 170600-031
17 171052-660
18 173377-228
19 182133-104
20 182133-105
21 21Blank
01 41Blank
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-10-26
Pay. Date : 2012-12-19
DMF Number : 15585
Submission : 2001-08-15
Status : Active
Type : II
Certificate Number : CEP 2014-331 - Rev 04
Issue Date : 2025-05-19
Type : Chemical
Substance Number : 2760
Status : Valid
Registration Number : 302MF10029
Registrant's Address : Na vlcinci 16/3 Klasterni Hradisko 779 00 Olomouc Czech Republic
Initial Date of Registration : 2020-02-13
Latest Date of Registration :
NDC Package Code : 63278-0488
Start Marketing Date : 2002-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hiple Co., Ltd.
Registration Date : 2013-12-20
Registration Number : 20131220-200-I-380-02
Manufacturer Name : Farmak as
Manufacturer Address : Na Vlcinci 16/3, Klasterni Hradisko, 779 00 Olomouc, Czech Republic
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Bhavna Laboratories is an API & Intermediate manufacturer focusing on the muscle relaxant & ophthalmic segments.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
GDUFA
DMF Review : Reviewed
Rev. Date : 2026-03-13
Pay. Date : 2026-02-24
DMF Number : 36595
Submission : 2021-12-09
Status : Active
Type : II
Certificate Number : R0-CEP 2021-507 - Rev 00
Issue Date : 2023-07-04
Type : Chemical
Substance Number : 2760
Status : Valid
Date of Issue : 2024-02-12
Valid Till : 2027-02-11
Written Confirmation Number : WC-0407
Address of the Firm :
NDC Package Code : 70600-031
Start Marketing Date : 2021-12-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ASMF, BR |
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-23
Pay. Date : 2012-12-03
DMF Number : 22510
Submission : 2009-01-28
Status : Active
Type : II
Certificate Number : CEP 2022-161 - Rev 00
Issue Date : 2024-02-02
Type : Chemical
Substance Number : 2760
Status : Valid
NDC Package Code : 82133-104
Start Marketing Date : 2023-12-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25051
Submission : 2011-07-05
Status : Active
Type : II
Date of Issue : 2022-06-30
Valid Till : 2025-07-28
Written Confirmation Number : WC-0063
Address of the Firm :
NDC Package Code : 53747-036
Start Marketing Date : 2011-07-05
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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A SIMBRINZA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SIMBRINZA, including repackagers and relabelers. The FDA regulates SIMBRINZA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SIMBRINZA 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 SIMBRINZA supplier is an individual or a company that provides SIMBRINZA active pharmaceutical ingredient (API) or SIMBRINZA finished formulations upon request. The SIMBRINZA suppliers may include SIMBRINZA API manufacturers, exporters, distributors and traders.
click here to find a list of SIMBRINZA suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
We have 35 companies offering SIMBRINZA
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