17 Feb 2026
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16 Oct 2025
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26 Feb 2025
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Latest Content by PharmaCompass
KEY EXCIPIENTS
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01 1Aluminium Hydroxide
02 2Aluminum
03 6Calcium Carbonate
04 2Magaldrate
05 4Magnesium Carbonate
06 15Magnesium Hydroxide
07 1Paracetamol
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01 1Active
02 30Blank
01 4Valid
02 27Blank
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01 31Blank
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01 112784-188
02 112784-192
03 112784-196
04 112784-198
05 112784-204
06 112784-205
07 112784-330
08 112784-424
09 112784-425
10 112784-441
11 112784-442
12 112784-448
13 112784-451
14 112784-456
15 112784-458
16 112784-459
17 212784-460
18 112784-461
19 158103-115
20 158103-132
21 158103-134
22 158103-139
23 158103-141
24 158103-142
25 158103-143
26 167417-239
27 167417-243
28 167417-249
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39418
Submission : 2024-03-06
Status : Active
Type : II
Certificate Number : R1-CEP 2008-190 - Rev 00
Issue Date : 2014-10-07
Type : Chemical
Substance Number : 39
Status : Valid
NDC Package Code : 67417-249
Start Marketing Date : 2026-01-14
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (35.4kg/100kg 35.4kg/100kg)
Marketing Category : DRUG FOR FURTHER PRO...
Certificate Number : CEP 2008-270 - Rev 01
Issue Date : 2025-03-25
Type : Chemical
Substance Number : 311
Status : Valid
Certificate Number : CEP 2008-264 - Rev 01
Issue Date : 2025-03-26
Type : Chemical
Substance Number : 311
Status : Valid
Certificate Number : R0-CEP 2022-054 - Rev 00
Issue Date : 2023-02-10
Type : Chemical
Substance Number : 39
Status : Valid
NDC Package Code : 12784-459
Start Marketing Date : 2022-09-16
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (97kg/100kg)
Marketing Category : DRUG FOR FURTHER PRO...
NDC Package Code : 12784-442
Start Marketing Date : 2019-12-09
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (61.5kg/100kg 5kg/100kg)
Marketing Category : DRUG FOR FURTHER PRO...
NDC Package Code : 58103-139
Start Marketing Date : 2021-03-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (58kg/100kg)
Marketing Category : DRUG FOR FURTHER PRO...
NDC Package Code : 58103-143
Start Marketing Date : 2023-11-02
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (90kg/100kg)
Marketing Category : DRUG FOR FURTHER PRO...
NDC Package Code : 58103-141
Start Marketing Date : 2023-08-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (77.5kg/100kg 16kg/100kg)
Marketing Category : DRUG FOR FURTHER PRO...
NDC Package Code : 58103-142
Start Marketing Date : 2023-08-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (77.5kg/100kg 16kg/100kg)
Marketing Category : DRUG FOR FURTHER PRO...
NDC Package Code : 58103-134
Start Marketing Date : 2020-01-29
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (58kg/100kg)
Marketing Category : DRUG FOR FURTHER PRO...
Spi Pharma is a supplier offers 9 products (APIs, Excipients or Intermediates).
Find Magnesium Hydroxide bulk with DMF, CEP offered by Spi Pharma
Find Aluminum bulk with CEP offered by Spi Pharma
Find Magnesium Hydroxide bulk with CEP offered by Spi Pharma
Find Aluminium Hydroxide bulk offered by Spi Pharma
Find Calcium Carbonate bulk offered by Spi Pharma
Find Magaldrate bulk offered by Spi Pharma
Find Magnesium Carbonate bulk offered by Spi Pharma
Find Magnesium Hydroxide bulk offered by Spi Pharma
Find Paracetamol bulk offered by Spi Pharma