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 1Sanofi
07 1Veranova
08 1Aspen API
09 1Rusan Pharma
10 1Parand Darou Pharma
11 1TAPI Technology & API Services
12 2Arevipharma
13 1Biotechnica DWC
14 1Cambrex Corporation
15 1Chattem Chemicals, Inc
16 1Chr. Olesen Synthesis A.S
17 1Danesh Kimia Pharmed
18 1Kimyagaran
19 1Mahban Group
20 2Mallinckrodt Pharmaceuticals
21 1Micro Orgo Chem
22 1OmnisMed Pharmaceuticals
23 2Pioneer Agro Extracts
24 1Reckitt Benckiser
25 1Resonance Laboratories Pvt. Ltd
26 1Salars Spa
27 3Siegfried AG
28 1Sun Pharmaceutical Industries Limited
29 2Unichem Laboratories Limited
30 1Unipex
01 1Algeria
02 1Denmark
03 3France
04 2Germany
05 8India
06 6Iran
07 2Ireland
08 1Israel
09 1Italy
10 1Netherlands
11 3Switzerland
12 1Taiwan
13 5U.S.A
14 2United Kingdom
01 18Active
02 3Inactive
03 16Blank
01 1Expired
02 14Valid
03 1Withdrawn by Holder
04 21Blank
01 1218MF11027
02 1231MF10001
03 35Blank
01 1665/131411
02 1WC-0063
03 1WC-0168
04 1WC-0174
05 1WC-0174a1
06 1WC-0278
07 31Blank
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 : 2012-11-23
Pay. Date : 2012-11-23
DMF Number : 23683
Submission : 2010-04-05
Status : Active
Type : II
Certificate Number : R1-CEP 2010-142 - Rev 05
Issue Date : 2023-08-23
Type : Chemical
Substance Number : 1181
Status : Valid
NDC Package Code : 51634-0608
Start Marketing Date : 2017-07-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Date of Issue : 2018-01-09
Valid Till : 2019-01-09
Written Confirmation Number : 665/131411
Address of the Firm :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R1-CEP 2010-291 - Rev 00
Issue Date : 2016-04-11
Type : Chemical
Substance Number : 1181
Status : Withdrawn by Holder
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-26
Pay. Date : 2012-11-30
DMF Number : 19109
Submission : 2006-01-12
Status : Active
Type : II
Certificate Number : R1-CEP 2002-168 - Rev 07
Issue Date : 2019-09-25
Type : Chemical
Substance Number : 1181
Status : Valid
Registration Number : 218MF11027
Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
Initial Date of Registration : 2006-12-28
Latest Date of Registration : --
NDC Package Code : 12707-035
Start Marketing Date : 2017-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ROW |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7099
Submission : 1987-08-06
Status : Active
Type : II
Certificate Number : R1-CEP 2017-228 - Rev 00
Issue Date : 2023-01-23
Type : Chemical
Substance Number : 1181
Status : Valid
Date of Issue : 2021-08-27
Valid Till : 2024-06-10
Written Confirmation Number : WC-0278
Address of the Firm :
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 : 2012-11-30
Pay. Date : 2012-11-13
DMF Number : 16419
Submission : 2003-01-29
Status : Active
Type : II
Certificate Number : CEP 2004-251 - Rev 05
Issue Date : 2024-05-14
Type : Chemical
Substance Number : 1181
Status : Valid
Available Reg Filing : CA, ASMF |
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-06-04
Pay. Date : 2016-09-08
DMF Number : 29885
Submission : 2016-08-16
Status : Active
Type : II
NDC Package Code : 51634-0608
Start Marketing Date : 2017-07-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-10-26
Pay. Date : 2012-12-03
DMF Number : 21060
Submission : 2007-11-12
Status : Active
Type : II
Certificate Number : CEP 2024-011 - Rev 00
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 1181
Status : Valid
NDC Package Code : 0792-0630
Start Marketing Date : 2011-11-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-29
Pay. Date : 2013-02-14
DMF Number : 25507
Submission : 2011-11-15
Status : Active
Type : II
Certificate Number : R1-CEP 2007-325 - Rev 01
Issue Date : 2022-10-14
Type : Chemical
Substance Number : 1181
Status : Valid
NDC Package Code : 0792-0630
Start Marketing Date : 2011-11-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-07-23
Pay. Date : 2024-02-22
DMF Number : 38839
Submission : 2024-02-29
Status : Active
Type : II
NDC Package Code : 0792-0630
Start Marketing Date : 2011-11-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-15
Pay. Date : 2021-07-14
DMF Number : 35988
Submission : 2021-07-30
Status : Active
Type : II
Certificate Number : R0-CEP 2020-339 - Rev 01
Issue Date : 2022-06-21
Type : Chemical
Substance Number : 1181
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33799
Submission : 2023-02-21
Status : Active
Type : II
NDC Package Code : 59116-4980
Start Marketing Date : 2018-07-31
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 : 12412
Submission : 1997-03-10
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-04-22
Pay. Date : 2021-03-05
DMF Number : 35192
Submission : 2021-02-26
Status : Active
Type : II
NDC Package Code : 61960-9064
Start Marketing Date : 2021-02-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-16
Pay. Date : 2013-06-27
DMF Number : 24594
Submission : 2011-01-24
Status : Active
Type : II
Certificate Number : CEP 2021-431 - Rev 02
Issue Date : 2024-06-28
Type : Chemical
Substance Number : 1181
Status : Valid
NDC Package Code : 10920-590
Start Marketing Date : 2011-03-02
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 : 22887
Submission : 2009-07-02
Status : Active
Type : II
NDC Package Code : 53747-012
Start Marketing Date : 2009-06-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-09-19
Pay. Date : 2024-08-13
DMF Number : 40195
Submission : 2024-07-25
Status : Active
Type : II
Certificate Number : R1-CEP 2009-346 - Rev 01
Issue Date : 2017-02-20
Type : Chemical
Substance Number : 1181
Status : Valid
NDC Package Code : 10920-590
Start Marketing Date : 2011-03-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-30
Pay. Date : 2012-11-30
DMF Number : 24927
Submission : 2012-05-02
Status : Active
Type : II
Certificate Number : R0-CEP 2023-107 - Rev 00
Issue Date : 2023-08-24
Type : Chemical
Substance Number : 1181
Status : Valid
NDC Package Code : 0406-2910
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 : 2020-01-14
Pay. Date : 2020-01-09
DMF Number : 22856
Submission : 2009-08-27
Status : Active
Type : II
Certificate Number : R1-CEP 2009-312 - Rev 00
Issue Date : 2017-11-08
Type : Chemical
Substance Number : 1181
Status : Valid
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
NDC Package Code : 62756-316
Start Marketing Date : 2020-05-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26366
Submission : 2012-11-27
Status : Active
Type : II
Certificate Number : R1-CEP 2013-048 - Rev 00
Issue Date : 2021-05-04
Type : Chemical
Substance Number : 1181
Status : Valid
NDC Package Code : 0406-2910
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 23756
Submission : 2010-04-14
Status : Inactive
Type : II
Certificate Number : R0-CEP 2010-166 - Rev 01
Issue Date : 2014-09-04
Type : Chemical
Substance Number : 1181
Status : Expired
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7684
Submission : 1988-09-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7923
Submission : 1989-01-23
Status : Inactive
Type : II
Certificate Number : CEP 2009-223 - Rev 01
Issue Date : 2024-11-07
Type : Chemical
Substance Number : 1181
Status : Valid
Date of Issue : 2022-06-30
Valid Till : 2025-07-28
Written Confirmation Number : WC-0063
Address of the Firm :
NDC Package Code : 53747-012
Start Marketing Date : 2009-06-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2019-09-12
Valid Till : 2021-09-11
Written Confirmation Number : WC-0174
Address of the Firm :
Certificate Number : CEP 2005-095 - Rev 01
Issue Date : 2023-10-02
Type : Chemical
Substance Number : 1181
Status : Valid
Registration Number : 231MF10001
Registrant's Address : 206, Eric House, 16th Road, Chembur, Mumbai-400071. INDIA
Initial Date of Registration : 2019-01-10
Latest Date of Registration : --
Date of Issue : 2019-09-12
Valid Till : 2022-09-11
Written Confirmation Number : WC-0174a1
Address of the Firm :
A SUBOXONE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SUBOXONE, including repackagers and relabelers. The FDA regulates SUBOXONE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SUBOXONE 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 SUBOXONE supplier is an individual or a company that provides SUBOXONE active pharmaceutical ingredient (API) or SUBOXONE finished formulations upon request. The SUBOXONE suppliers may include SUBOXONE API manufacturers, exporters, distributors and traders.
click here to find a list of SUBOXONE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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