Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 3Symbiotec Pharmalab
02 1Axplora
03 1LGM Pharma
04 1Inabata France S.A.S
05 1Coral Drugs Private Limited
06 1Gonane Pharma
07 1Jai Radhe Sales
08 1Vamsi Labs
09 2TAPI Technology & API Services
10 1Anhui HaiKang Pharmaceutical
11 1Anuh Pharma LTD
12 1Avik Pharmaceutical Limited
13 1Balaji Corporation
14 1Cerata Pharmaceuticals
15 1Curia
16 1Envee Drugs
17 2GSK
18 1Great Pacific Exports
19 1Grefuel
20 1Guangzhou Tosun Pharmaceutical
21 1Halcyon Labs Private Limited
22 1Henan Lihua Pharmaceutical
23 1Hovione
24 1JIANGSU GRAND XIANLE PHARMACEUTICAL CO LTD
25 1Maharshi Pharma Chem
26 1Mahima Life Sciences
27 1NEWCHEM SPA
28 2Rumit Group of Companies
29 1SM BIOMED
30 1Sicor Societa Italiana Corticosteroidi Srl
31 1Sneha Medicare Pvt Ltd
32 1Sudarshan Pharma
33 1Swati Spentose
34 1Symbiotica Specialty Ingredients
35 1Taro Pharmaceutical Industries
36 1Teva Pharmaceutical Industries
37 1Tianjin Pacific Chemical & Pharmaceutical Co., Ltd
38 1Unimax Group
39 1Vijayasri Organics Limited
40 1Xian Tian Guangyuan Biotech
41 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
42 1Blank
01 7China
02 1France
03 1Germany
04 24India
05 3Israel
06 2Italy
07 2Malaysia
08 1Portugal
09 3U.S.A
10 2United Kingdom
11 1Blank
01 8Active
02 6Inactive
03 33Blank
01 1Expired
02 10Valid
03 2Withdrawn by Holder
04 34Blank
01 1218MF10735
02 1222MF10016
03 1222MF10130
04 1229MF10086
05 43Blank
01 1WC-0009
02 1WC-0161A2
03 2WC-0162A2
04 1WC-0169
05 1WC-0429
06 1WC-0485
07 1WC-241
08 1WC-247
09 38Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-04-11
Pay. Date : 2012-12-31
DMF Number : 20821
Submission : 2007-08-29
Status : Active
Type : II
Certificate Number : R1-CEP 2007-263 - Rev 02
Issue Date : 2016-01-22
Type : Chemical
Substance Number : 2127
Status : Valid
Registration Number : 229MF10086
Registrant's Address : 385/2, Pigdamber, Off. A. B. Road, Rau, Indore 453331 (M.P.) India
Initial Date of Registration : 2017-04-25
Latest Date of Registration : --
Date of Issue : 2022-09-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
NDC Package Code : 22552-0006
Start Marketing Date : 2017-12-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2021-11-10
Registration Number : 20121126-93-E-103-07(A)
Manufacturer Name : Symbiotec Pharmalab Pvt. Limited
Manufacturer Address : 385/2 Gram Pigdamber, Near Hotel Mashal, Off AB Road, Rau, Indore-453 331 (MP) India
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-23
Pay. Date : 2015-02-17
DMF Number : 8336
Submission : 1989-12-09
Status : Active
Type : II
Certificate Number : R1-CEP 2011-135 - Rev 03
Issue Date : 2021-12-16
Type : Chemical
Substance Number : 2127
Status : Valid
Registration Number : 222MF10130
Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy
Initial Date of Registration : 2010-04-12
Latest Date of Registration : --
NDC Package Code : 46439-8708
Start Marketing Date : 2000-10-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Galderma Korea Co., Ltd.
Registration Date : 2012-11-22
Registration Number : 20121123-93-E-100-06
Manufacturer Name : Farmabios SpA
Manufacturer Address : via Pavia 1 27027 GROPELLO CAIROLI (PV) (microchem SRL, Via Turati 2 IT-29017 Fiorenzuola D'Arda (PC), Italy)
Available Reg Filing : SAU |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Date of Issue : 2022-09-16
Valid Till : 2025-07-05
Written Confirmation Number : WC-0009
Address of the Firm :
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
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 : 2012-11-29
Pay. Date : 2012-11-13
DMF Number : 6814
Submission : 1987-01-23
Status : Active
Type : II
Certificate Number : R1-CEP 2007-066 - Rev 05
Issue Date : 2022-05-18
Type : Chemical
Substance Number : 2127
Status : Valid
Available Reg Filing : CA, ASMF |
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0006
Start Marketing Date : 2017-12-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2021-11-10
Registration Number : 20121126-93-E-103-07(A)
Manufacturer Name : Symbiotec Pharmalab Pvt. Limited
Manufacturer Address : 385/2 Gram Pigdamber, Near Hotel Mashal, Off AB Road, Rau, Indore-453 331 (MP) India
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
NDC Package Code : 22552-0006
Start Marketing Date : 2017-12-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2021-11-10
Registration Number : 20121126-93-E-103-07(A)
Manufacturer Name : Symbiotec Pharmalab Pvt. Limited
Manufacturer Address : 385/2 Gram Pigdamber, Near Hotel Mashal, Off AB Road, Rau, Indore-453 331 (MP) India
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 : 18202
Submission : 2005-03-28
Status : Inactive
Type : II
Available Reg Filing : CA, ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-03-13
Pay. Date : 2015-03-06
DMF Number : 14648
Submission : 1999-12-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24015
Submission : 2010-07-23
Status : Active
Type : II
Certificate Number : R1-CEP 2009-221 - Rev 00
Issue Date : 2015-10-19
Type : Chemical
Substance Number : 2127
Status : Valid
NDC Package Code : 52128-158
Start Marketing Date : 2011-11-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2017-05-16
Registration Number : 20170516-93-E-131-08
Manufacturer Name : Symbiotica Specialty Ingredients Sdn. Bhd.
Manufacturer Address : No. 518, Jalan Waja 4, Taman Industri Waja, 09000 Kulim, Kedah, Malaysia
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21216
Submission : 2008-01-02
Status : Active
Type : II
Date of Issue : 2020-02-24
Valid Till : 2022-07-02
Written Confirmation Number : WC-241
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30752
Submission : 2016-07-01
Status : Active
Type : II
Date of Issue : 2022-06-07
Valid Till : 2024-10-07
Written Confirmation Number : WC-0429
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26191
Submission : 2012-06-29
Status : Active
Type : II
Certificate Number : R1-CEP 2011-095 - Rev 01
Issue Date : 2021-08-25
Type : Chemical
Substance Number : 2127
Status : Valid
Registration Number : 222MF10016
Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain
Initial Date of Registration : 2010-01-07
Latest Date of Registration : --
NDC Package Code : 65089-0003
Start Marketing Date : 1994-02-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Registrant Name : JDW Pharmaceutical Co., Ltd.
Registration Date : 2011-08-12
Registration Number : 20080530-93-E-56-03(5)
Manufacturer Name : Crystal Pharma, SA,
Manufacturer Address : Parque Tecnologico de Boecillo, Parcela 105, 47151-Boecillo (Valladolid), Spain
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25444
Submission : 2012-12-20
Status : Inactive
Type : II
Certificate Number : CEP 2011-034 - Rev 04
Issue Date : 2024-10-24
Type : Chemical
Substance Number : 2127
Status : Valid
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2012-03-23
Registration Number : 20120323-93-E-99-05
Manufacturer Name : Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)
Manufacturer Address : Cobden Street, Montrose, Angus, DD10 8EA
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9781
Submission : 1992-07-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22650
Submission : 2008-12-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22226
Submission : 2008-11-20
Status : Inactive
Type : II
Certificate Number : CEP 2017-294 - Rev 04
Issue Date : 2024-08-19
Type : Chemical
Substance Number : 2127
Status : Valid
NDC Package Code : 24002-0012
Start Marketing Date : 2009-08-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R0-CEP 2020-395 - Rev 00
Issue Date : 2021-06-01
Type : Chemical
Substance Number : 2127
Status : Valid
NDC Package Code : 64958-0100
Start Marketing Date : 1997-09-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : CEP 2023-058 - Rev 00
Issue Date : 2024-11-13
Type : Chemical
Substance Number : 2127
Status : Valid
Certificate Number : R0-CEP 2007-164 - Rev 01
Issue Date : 2013-08-06
Type : Chemical
Substance Number : 2127
Status : Expired
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2012-03-23
Registration Number : 20120323-93-E-99-05
Manufacturer Name : Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)
Manufacturer Address : Cobden Street, Montrose, Angus, DD10 8EA
Date of Issue : 2020-09-25
Valid Till : 2023-09-24
Written Confirmation Number : WC-0485
Address of the Firm :
Date of Issue : 2022-06-28
Valid Till : 2025-07-02
Written Confirmation Number : WC-247
Address of the Firm :
Certificate Number : R1-CEP 2009-315 - Rev 02
Issue Date : 2020-06-04
Type : Chemical
Substance Number : 2127
Status : Valid
Date of Issue : 2019-06-27
Valid Till : 2022-07-02
Written Confirmation Number : WC-0169
Address of the Firm :
Registrant Name : Hiple Co., Ltd.
Registration Date : 2020-07-22
Registration Number : 20200722-93-E-160-09
Manufacturer Name : Avik Pharmaceutical Limited@[Betamethasone Manufacturer]Hunan Yuxin Pharmaceutical Co. Ltd.
Manufacturer Address : A-1/7 & A-1/8, 1ST Phase, GIDC, City : Vapi - 396 195, Dist. Valsad, Gujarat State, India@[Betamethasone Manufacturer]Longxutang, Shuangqing District Shaoyang City Hunan Province, China
Certificate Number : R1-CEP 2008-245 - Rev 00
Issue Date : 2014-11-13
Type : Chemical
Substance Number : 2127
Status : Withdrawn by Holder
Certificate Number : R0-CEP 2005-172 - Rev 00
Issue Date : 2010-06-21
Type : Chemical
Substance Number : 2127
Status : Withdrawn by Holder
Registrant Name : Medica Korea Co., Ltd.
Registration Date : 2012-02-03
Registration Number : 20071204-93-E-15-01(4)
Manufacturer Name : ANUH PHARMA LTD
Manufacturer Address : PLOT NO. D-5/8, D-5/9, TTC Industrial Area, MIDC TURBHE, NAVI MUMBAI – 400703, India
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 : 8096
Submission : 1989-04-25
Status : Inactive
Type : II
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A Clobetasol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clobetasol, including repackagers and relabelers. The FDA regulates Clobetasol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clobetasol 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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