Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.

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01 1Siegfried AG
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1LGM Pharma
04 1Asia Pioneer Pharmaceuticals
05 1BASF
06 1Catalent Pharma Solutions
07 2Chongqing Huapont Pharmaceutical
08 1EASTMAN KODAK
09 1F. Hoffmann-La Roche
10 1Hangzhou Deli Chemical
11 1Helsinn Advanced Synthesis
12 1Hetero Drugs
13 1Ipca Laboratories
14 1JIANGXI HENGXIANG PHARMACEUTICAL TECHNOLOGY CO LTD
15 1Kimia Biosciences
16 1Kukjeon Pharmaceutical
17 1Nishchem International Pvt. Ltd
18 2Olon S.p.A
19 1Qingdao Qingmei Biotech
20 1RP SCHERER GMBH & CO. KG
21 1SAMEX OVERSEAS
22 1Shanghai New Hualian Pharmaceutical
23 1Shanghai Pharma Group
24 1Sionc Pharmaceuticals
25 2Sun Pharmaceutical Industries Limited
26 1Unipex
27 1Blank
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01 7China
02 1France
03 2Germany
04 9India
05 2Italy
06 1South Korea
07 3Switzerland
08 4U.S.A
09 1Blank
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01 9Active
02 6Inactive
03 15Blank
01 8Valid
02 2Withdrawn by Holder
03 20Blank
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01 1307MF10079
02 29Blank
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01 1WC-0011
02 1WC-0040
03 1WC-0168
04 27Blank
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01 120171226-209-J-4
02 120180712-209-J-72
03 120190327-209-J-207
04 120250825-209-J-1978
05 26Blank
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01 117337-0024
02 117337-0083
03 148943-0010
04 165724-0051
05 165977-0135
06 167262-0003
07 176055-0010
08 23Blank
01 30Blank
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-23
Pay. Date : 2013-08-09
DMF Number : 4676
Submission : 1982-09-27
Status : Active
Type : II
Certificate Number : R1-CEP 1999-068 - Rev 07
Issue Date : 2023-03-10
Type : Chemical
Substance Number : 1019
Status : Valid
Registration Number : 307MF10079
Registrant's Address : Karlstrasse 15, 32423, Minden, Federal Republic of Germany
Initial Date of Registration : 2025-07-09
Latest Date of Registration :
NDC Package Code : 65724-0051
Start Marketing Date : 2010-06-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-13
Pay. Date : 2013-09-25
DMF Number : 27484
Submission : 2013-09-27
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-31
Pay. Date : 2018-03-19
DMF Number : 32517
Submission : 2018-08-31
Status : Active
Type : II
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19191
Submission : 2005-10-25
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-14
Pay. Date : 2012-12-10
DMF Number : 7485
Submission : 1988-05-16
Status : Active
Type : II
Certificate Number : R1-CEP 1996-082 - Rev 12
Issue Date : 2022-04-12
Type : Chemical
Substance Number : 1019
Status : Valid
NDC Package Code : 17337-0083
Start Marketing Date : 2017-09-01
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 : 14493
Submission : 1999-10-14
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4887
Submission : 1983-03-23
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15169
Submission : 2000-11-29
Status : Inactive
Type : II
Certificate Number : R1-CEP 2002-011 - Rev 06
Issue Date : 2023-05-25
Type : Chemical
Substance Number : 1019
Status : Valid
Date of Issue : 2025-08-05
Valid Till : 2028-06-02
Written Confirmation Number : WC-0011
Address of the Firm :

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13071
Submission : 1998-07-01
Status : Inactive
Type : II

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PharmaCompass offers a list of Isotretinoin 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 Isotretinoin manufacturer or Isotretinoin supplier for your needs.
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A Roacutan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Roacutan, including repackagers and relabelers. The FDA regulates Roacutan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Roacutan 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 Roacutan supplier is an individual or a company that provides Roacutan active pharmaceutical ingredient (API) or Roacutan finished formulations upon request. The Roacutan suppliers may include Roacutan API manufacturers, exporters, distributors and traders.
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