Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
01 1Rochem International Inc
02 1DKSH
03 1Admiron Life Sciences Private Limited
04 1Advanced Enzyme Technologies Ltd
05 1Akums Lifesciences
06 1Alembic Pharmaceuticals Limited
07 1Aragen Life Sciences
08 2BENE PHARMACHEM GMBH AND CO KG
09 1CF Pharma
10 1Micro Labs Limited
11 1Molclone
12 1Pioneer Pharma
13 1Swati Spentose
14 1Viatris
01 2Germany
02 1Hungary
03 8India
04 1Iraq
05 1Switzerland
06 2U.S.A
01 7Active
02 3Inactive
03 5Blank
01 15Blank
01 15Blank
01 1WC-0124
02 1WC-0165
03 1WC-0351
04 1WC-0448
05 11Blank
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21248
Submission : 2008-01-10
Status : Active
Type : II
NDC Package Code : 42897-001
Start Marketing Date : 1996-11-26
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 : 25011
Submission : 2011-05-31
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-11-12
Pay. Date : 2019-08-28
DMF Number : 34095
Submission : 2019-09-13
Status : Active
Type : II
Date of Issue : 2019-10-31
Valid Till : 2022-07-02
Written Confirmation Number : WC-0124
Address of the Firm :
NDC Package Code : 29967-0001
Start Marketing Date : 2009-07-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2022-06-15
Registration Number : 20220615-209-J-1314
Manufacturer Name : Aragen Life Sciences Limited
Manufacturer Address : Manufacturing Unit-I, Plot No. 28A, IDA, Nacharam Village, Uppal Mandal, Medchal - Malkajgiri District, Hyderabad City, PinCode 500076 Telangana State, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25827
Submission : 2012-02-22
Status : Active
Type : II
Date of Issue : 2019-07-08
Valid Till : 2022-07-08
Written Confirmation Number : WC-0165
Address of the Firm :
NDC Package Code : 52119-005
Start Marketing Date : 2012-08-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-06-14
Pay. Date : 2023-05-24
DMF Number : 38294
Submission : 2023-05-15
Status : Active
Type : II
NDC Package Code : 42571-476
Start Marketing Date : 2024-07-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31045
Submission : 2016-10-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31208
Submission : 2017-01-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4439
Submission : 1981-04-14
Status : Inactive
Type : II
NDC Package Code : 42897-001
Start Marketing Date : 1996-11-26
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 : 8811
Submission : 1990-09-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22582
Submission : 2009-02-20
Status : Inactive
Type : II
Date of Issue : 2022-07-15
Valid Till : 2025-07-25
Written Confirmation Number : WC-0448
Address of the Firm :
Date of Issue : 2022-07-01
Valid Till : 2025-05-05
Written Confirmation Number : WC-0351
Address of the Firm :
NDC Package Code : 69723-001
Start Marketing Date : 2015-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Pentosan Polysulfate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentosan Polysulfate Sodium, including repackagers and relabelers. The FDA regulates Pentosan Polysulfate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentosan Polysulfate Sodium 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 Pentosan Polysulfate Sodium supplier is an individual or a company that provides Pentosan Polysulfate Sodium active pharmaceutical ingredient (API) or Pentosan Polysulfate Sodium finished formulations upon request. The Pentosan Polysulfate Sodium suppliers may include Pentosan Polysulfate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Pentosan Polysulfate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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