Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
01 1Supriya Lifescience
02 1Suanfarma
03 1Pharm-RX Chemical
04 1LGM Pharma
05 1Rochem International Inc
06 1Temad Co
07 1Jai Radhe Sales
08 1Malladi Drugs & Pharmaceuticals Limited
09 1Virupaksha Organics
10 1Tenatra Chemie
11 1ALPS Pharmaceutical Ind. Co. Ltd.
12 2Aurobindo Pharma Limited
13 1Biotechnica DWC
14 1Chifeng Arker Pharmaceutical Technology Co. Ltd.
15 1Dasami Lab
16 1Divis Laboratories
17 1Dr. Raju’s Pharma Solutions
18 1Exemed Pharmaceuticals
19 2F. Hoffmann-La Roche
20 1Gurvey & Berry
21 1Hy-Gro Chemicals Pharmtek
22 1JRC
23 1Kreative Organics
24 1Lonza Inc & Lonza America Inc
25 1Melody Healthcare Pvt Ltd
26 1Neha Chemicals
27 1Nishchem International Pvt. Ltd
28 1Oneiro Lifecare
29 1Orbit Lifescience
30 1Osmopharm
31 1Qidong Dongyue Pharmaceutical Co., Ltd.
32 1Royal DSM
33 1SIGMA TAU
34 1Sneha Medicare Pvt Ltd
35 1Solara Active Pharma Sciences
36 1Srini Pharmaceuticals
37 1Standard Chem. & Pharm. Co., Ltd
38 1Wanbury Limited
39 2Wockhardt
40 2Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd
41 2Blank
01 1Algeria
02 1Canada
03 5China
04 24India
05 1Iran
06 1Japan
07 1Netherlands
08 1Spain
09 3Switzerland
10 6U.S.A
11 2Blank
01 16Active
02 5Inactive
03 25Blank
01 10Valid
02 1Withdrawn by Holder
03 35Blank
01 1217MF10567
02 1218MF10104
03 1219MF10119
04 1220MF10108
05 1220MF10121
06 1302MF10047
07 1303MF10152
08 39Blank
01 1WC-0023
02 1WC-0031
03 1WC-0075
04 1WC-0122
05 1WC-0127
06 1WC-0180
07 1WC-0218
08 1WC-0227n
09 1WC-0272
10 1WC-0276
11 1WC-0313
12 35Blank
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33575
Submission : 2019-03-25
Status : Active
Type : II
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0218
Address of the Firm :
NDC Package Code : 61281-6500
Start Marketing Date : 2017-01-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-05-28
Pay. Date : 2019-04-25
DMF Number : 32402
Submission : 2018-01-04
Status : Active
Type : II
Certificate Number : CEP 2018-133 - Rev 01
Issue Date : 2024-06-28
Type : Chemical
Substance Number : 20
Status : Valid
NDC Package Code : 57218-760
Start Marketing Date : 2017-02-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-08-23
Pay. Date : 2024-08-19
DMF Number : 39295
Submission : 2024-01-23
Status : Active
Type : II
Available Reg Filing : ASMF |
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27836
Submission : 2013-12-12
Status : Active
Type : II
NDC Package Code : 68166-004
Start Marketing Date : 2019-10-30
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 : 34902
Submission : 2020-08-26
Status : Active
Type : II
Certificate Number : R0-CEP 2021-026 - Rev 00
Issue Date : 2022-01-05
Type : Chemical
Substance Number : 20
Status : Valid
NDC Package Code : 66653-001
Start Marketing Date : 2013-06-01
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 : 26762
Submission : 2012-12-26
Status : Active
Type : II
Certificate Number : R1-CEP 2013-288 - Rev 00
Issue Date : 2022-06-28
Type : Chemical
Substance Number : 20
Status : Valid
Date of Issue : 2022-09-30
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-12-16
Pay. Date : 2022-11-22
DMF Number : 37412
Submission : 2022-10-31
Status : Active
Type : II
NDC Package Code : 70966-0031
Start Marketing Date : 1982-10-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-16
Pay. Date : 2013-05-09
DMF Number : 11935
Submission : 1996-04-18
Status : Active
Type : II
Certificate Number : R1-CEP 1998-053 - Rev 04
Issue Date : 2017-03-21
Type : Chemical
Substance Number : 20
Status : Valid
Registration Number : 303MF10152
Registrant's Address : Wockhardt Towers, Bandra-kurla Complex, Bandra (East), Mumbai-400 051, Maharashtra, India
Initial Date of Registration : 2021-09-28
Latest Date of Registration : --
Date of Issue : 2019-07-22
Valid Till : 2022-07-21
Written Confirmation Number : WC-0075
Address of the Firm :
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2022-01-27
Registration Number : 20210112-209-J-507(2)
Manufacturer Name : Wockhardt Ltd
Manufacturer Address : Plot No. 138, Ankleshwar-393 002, Dist. Bharuch, Gujarat State, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-09-21
Pay. Date : 2021-07-29
DMF Number : 32848
Submission : 2018-06-04
Status : Active
Type : II
Certificate Number : R0-CEP 2018-201 - Rev 00
Issue Date : 2021-03-17
Type : Chemical
Substance Number : 20
Status : Valid
Date of Issue : 2019-05-21
Valid Till : 2022-05-21
Written Confirmation Number : WC-0313
Address of the Firm :
NDC Package Code : 66174-0085
Start Marketing Date : 2017-08-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-01
Pay. Date : 2014-02-18
DMF Number : 27959
Submission : 2014-02-13
Status : Active
Type : II
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0023
Address of the Firm :
NDC Package Code : 59651-769
Start Marketing Date : 2024-01-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (20kg/50kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-17
Pay. Date : 2022-12-29
DMF Number : 37910
Submission : 2022-12-30
Status : Active
Type : II
NDC Package Code : 59651-769
Start Marketing Date : 2024-01-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (20kg/50kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36112
Submission : 2021-07-26
Status : Active
Type : II
Certificate Number : CEP 2021-257 - Rev 00
Issue Date : 2023-12-20
Type : Chemical
Substance Number : 20
Status : Valid
Date of Issue : 2024-03-01
Valid Till : 2026-12-03
Written Confirmation Number : WC-0276
Address of the Firm :
NDC Package Code : 60155-002
Start Marketing Date : 2020-07-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Pharmaceutical Co., Ltd.
Registration Date : 2023-10-27
Registration Number : 20231027-209-J-1558
Manufacturer Name : Exemed Pharmaceuticals
Manufacturer Address : Block No.628(A&B), ECP Canal Road, Village-Luna, Tai, Padra
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-09
Pay. Date : 2012-11-23
DMF Number : 12356
Submission : 1997-02-04
Status : Active
Type : II
Certificate Number : R1-CEP 1999-103 - Rev 06
Issue Date : 2018-07-20
Type : Chemical
Substance Number : 20
Status : Valid
Registration Number : 217MF10567
Registrant's Address : Divi Towers, 7-1-77/E/1/303, Dharam Karan Road, Ameerpet, Hyderabad-500 016, India
Initial Date of Registration : 2005-09-09
Latest Date of Registration : --
Date of Issue : 2022-06-16
Valid Till : 2025-06-16
Written Confirmation Number : WC-0031
Address of the Firm :
NDC Package Code : 62331-003
Start Marketing Date : 2002-01-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Johnson & Johnson Sales Co., Ltd.
Registration Date : 2023-06-26
Registration Number : 20180727-209-J-32(3)
Manufacturer Name : Divi's Laboratories Limited (Unit I)
Manufacturer Address : Lingojigudem Village, Choutuppal Mandal Yadadri Bhuvanagiri District, Telangana 508252 India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34241
Submission : 2019-10-31
Status : Active
Type : II
Certificate Number : CEP 2022-268 - Rev 00
Issue Date : 2024-09-03
Type : Chemical
Substance Number : 20
Status : Valid
Date of Issue : 2022-06-23
Valid Till : 2025-07-02
Written Confirmation Number : WC-0122
Address of the Firm :
NDC Package Code : 62350-0081
Start Marketing Date : 2019-08-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 395
Submission : 1960-08-10
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-23
Pay. Date : 2019-05-10
DMF Number : 33607
Submission : 2019-03-06
Status : Active
Type : II
Certificate Number : R1-CEP 2014-023 - Rev 00
Issue Date : 2020-07-23
Type : Chemical
Substance Number : 20
Status : Valid
Date of Issue : 2024-02-12
Valid Till : 2026-11-01
Written Confirmation Number : WC-0272
Address of the Firm :
NDC Package Code : 70761-101
Start Marketing Date : 2016-05-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER, FOR SUSPENSION (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7526
Submission : 1988-06-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3846
Submission : 1980-06-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13854
Submission : 1998-10-16
Status : Inactive
Type : II
Certificate Number : R0-CEP 2014-094 - Rev 01
Issue Date : 2016-05-18
Type : Chemical
Substance Number : 20
Status : Withdrawn by Holder
NDC Package Code : 66653-001
Start Marketing Date : 2013-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R0-CEP 2019-218 - Rev 00
Issue Date : 2021-04-30
Type : Chemical
Substance Number : 20
Status : Valid
Registration Number : 302MF10047
Registrant's Address : No. 8 Mysun Street, Hongshan Economic Development Zone, Chifeng, Inner Mongolia, China
Initial Date of Registration : 2020-04-17
Latest Date of Registration : --
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 : 823
Submission : 1964-07-02
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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 : 8535
Submission : 1990-04-12
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Dextromethorphan polistirex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dextromethorphan polistirex, including repackagers and relabelers. The FDA regulates Dextromethorphan polistirex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dextromethorphan polistirex 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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