Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
01 1Faran Shimi Pharmaceutical
02 2Noramco
03 1SCI Pharmtech
04 1Temad Co
05 1EUROAPI
06 1LGM Pharma
07 1Veranova
08 1Rusan Pharma
09 1Medichem S.A
10 1TAPI Technology & API Services
11 2Arevipharma
12 1Biotechnica DWC
13 1Chr. Olesen Synthesis A.S
14 1Embio Limited
15 1Fujifilm Diosynth Biotechnologies
16 1Johnson & Johnson Innovative Medicine
17 1Kimyagaran
18 1Mallinckrodt Pharmaceuticals
19 1Micro Orgo Chem
20 1OmnisMed Pharmaceuticals
21 2Pioneer Agro Extracts
22 1Resonance Laboratories Pvt. Ltd
23 2Siegfried AG
24 1Sun Pharmaceutical Industries Limited
25 2Tasmanian Alkaloids Pty Ltd
26 2Teva Pharmaceutical Industries
01 1Algeria
02 2Australia
03 1Denmark
04 1France
05 2Germany
06 7India
07 3Iran
08 1Ireland
09 3Israel
10 1Spain
11 2Switzerland
12 1Taiwan
13 5U.S.A
14 2United Kingdom
01 9Active
02 3Inactive
03 20Blank
01 11Valid
02 1Withdrawn by Holder
03 20Blank
01 1228MF10073
02 1305MF10007
03 30Blank
01 1665/119139
02 1WC-0174
03 1WC-0174a1
04 1WC-0278
05 28Blank
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-15
Pay. Date : 2012-11-23
DMF Number : 23684
Submission : 2010-04-05
Status : Active
Type : II
Certificate Number : CEP 2007-190 - Rev 05
Issue Date : 2024-06-20
Type : Chemical
Substance Number : 1180
Status : Valid
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Date of Issue : 2020-03-16
Valid Till : 2021-03-16
Written Confirmation Number : 665/119139
Address of the Firm :
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-08
Pay. Date : 2012-12-12
DMF Number : 26448
Submission : 2012-09-17
Status : Active
Type : II
Certificate Number : R1-CEP 2006-009 - Rev 04
Issue Date : 2019-12-11
Type : Chemical
Substance Number : 1180
Status : Valid
NDC Package Code : 12707-036
Start Marketing Date : 2017-12-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Available Reg Filing : ROW |
Certificate Number : R1-CEP 2015-387 - Rev 00
Issue Date : 2022-11-14
Type : Chemical
Substance Number : 1180
Status : Valid
Date of Issue : 2021-08-27
Valid Till : 2024-06-10
Written Confirmation Number : WC-0278
Address of the Firm :
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-25
Pay. Date : 2014-04-29
DMF Number : 28075
Submission : 2014-03-06
Status : Active
Type : II
Certificate Number : CEP 2008-041 - Rev 04
Issue Date : 2024-08-01
Type : Chemical
Substance Number : 1180
Status : Valid
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-03
Pay. Date : 2016-09-08
DMF Number : 30762
Submission : 2016-08-04
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-05-13
Pay. Date : 2019-04-02
DMF Number : 33097
Submission : 2019-03-18
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-24
Pay. Date : 2012-11-27
DMF Number : 24928
Submission : 2012-05-02
Status : Active
Type : II
Certificate Number : R1-CEP 2013-098 - Rev 00
Issue Date : 2021-06-24
Type : Chemical
Substance Number : 1180
Status : Valid
NDC Package Code : 0406-3205
Start Marketing Date : 2011-12-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-16
Pay. Date : 2013-01-28
DMF Number : 26052
Submission : 2012-05-14
Status : Active
Type : II
Certificate Number : CEP 2024-312 - Rev 00
Issue Date : 2024-08-21
Type : Chemical
Substance Number : 1180
Status : Valid
Registration Number : 305MF10007
Registrant's Address : Karlstrasse 15, 32423, Minden, Federal Republic of Germany
Initial Date of Registration : 2023-01-18
Latest Date of Registration : --
NDC Package Code : 0792-0631
Start Marketing Date : 2015-02-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-07-24
Pay. Date : 2015-03-06
DMF Number : 29091
Submission : 2015-03-02
Status : Active
Type : II
Certificate Number : R1-CEP 2007-324 - Rev 01
Issue Date : 2022-05-18
Type : Chemical
Substance Number : 1180
Status : Valid
NDC Package Code : 0792-0631
Start Marketing Date : 2015-02-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-23
Pay. Date : 2013-09-30
DMF Number : 27547
Submission : 2013-09-23
Status : Active
Type : II
Certificate Number : CEP 2021-298 - Rev 01
Issue Date : 2024-02-01
Type : Chemical
Substance Number : 1180
Status : Valid
NDC Package Code : 10920-593
Start Marketing Date : 2012-07-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11860
Submission : 1996-02-19
Status : Inactive
Type : II
Certificate Number : R1-CEP 1998-037 - Rev 03
Issue Date : 2016-07-22
Type : Chemical
Substance Number : 1180
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15126
Submission : 2000-11-02
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8542
Submission : 1990-04-27
Status : Inactive
Type : II
Certificate Number : CEP 2005-096 - Rev 01
Issue Date : 2023-10-02
Type : Chemical
Substance Number : 1180
Status : Valid
Date of Issue : 2019-09-12
Valid Till : 2022-09-11
Written Confirmation Number : WC-0174a1
Address of the Firm :
Date of Issue : 2019-09-12
Valid Till : 2021-09-11
Written Confirmation Number : WC-0174
Address of the Firm :
Certificate Number : R0-CEP 2021-098 - Rev 00
Issue Date : 2022-11-14
Type : Chemical
Substance Number : 1180
Status : Valid
Certificate Number : R1-CEP 2010-051 - Rev 01
Issue Date : 2017-01-20
Type : Chemical
Substance Number : 1180
Status : Valid
NDC Package Code : 10920-593
Start Marketing Date : 2012-07-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registration Number : 228MF10073
Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium
Initial Date of Registration : 2016-03-11
Latest Date of Registration : --
NDC Package Code : 12578-607
Start Marketing Date : 2011-05-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Buprenorphine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Buprenorphine, including repackagers and relabelers. The FDA regulates Buprenorphine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Buprenorphine 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 Buprenorphine supplier is an individual or a company that provides Buprenorphine active pharmaceutical ingredient (API) or Buprenorphine finished formulations upon request. The Buprenorphine suppliers may include Buprenorphine API manufacturers, exporters, distributors and traders.
click here to find a list of Buprenorphine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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