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01 1AACAS12BMAX ENHANCED, GMP GRADE

02 1BENZONUCLEASE

03 1BSAI

04 1BSPQI, GMP GRADE

05 1DEOXYRIBONUCLEASE

06 1DNASE 1, GMP GRADE

07 1IL-15

08 1IL-2

09 1IL-7

10 1INORGANIC PYROPHOSPHATASE

11 1MRNA CAP 2' -O-METHYLTRANSFERASE, GMP GRADE

12 1MRNA CAP 2’-O- METHYLTRANSFERASE

13 1PYROPHOSPHATASE, INORGANIC (YEAST), GMP GRADE

14 1RECOMBINANT CAS9 NUCLEASE

15 1RNASE INHIBITOR

16 1RNASE INHIBITOR, GMP GRADE

17 1RNASE R, GMP GRADE

18 1SEMAGLUTIDE PEPTIDE SEQUENCE (9-37)

19 1T7 RNA POLYMERASE

20 1T7 RNA POLYMERASE 2.0, GMP GRADE

21 1T7 RNA POLYMERASE, GMP GRADE

22 1VACCINIA CAPPING ENZYME

23 1VACCINIA CAPPING ENZYME, GMP GRADE

24 1XBAI, GMP GRADE

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PharmaCompass

02

PEGS Boston Summit
Not Confirmed
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03

PEGS Boston Summit
Not Confirmed
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04

PEGS Boston Summit
Not Confirmed
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07

Aacas12bmax Enhanced, Gmp Grade

PEGS Boston Summit
Not Confirmed
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Aacas12bmax Enhanced, Gmp Grade

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PEGS Boston Summit
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 41711

Submission : 2025-03-31

Status : Active

Type : II

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08

Benzonuclease

PEGS Boston Summit
Not Confirmed
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09

Bsai

PEGS Boston Summit
Not Confirmed
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10

Bspqi, Gmp Grade

PEGS Boston Summit
Not Confirmed
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