ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
01 2ASolution Pharmaceuticals
02 2Fermion Oy
03 1Nuray Chemicals Private Limited
04 1Rochem International Inc
05 1Chynops Pharma
06 1HRV Global Life Sciences
07 1Olpha
08 1Neuland Laboratories
09 1TAPI Technology & API Services
10 2Actavis Inc
11 2Alembic Pharmaceuticals Limited
12 1Arch Pharmalabs
13 1Assia Chemical Industries Ltd
14 2Cambrex Corporation
15 3F.I.S. Fabbrica Italiana Sintetici
16 3Jinan Jinda Pharmaceutical Chemistry Co Ltd
17 1Lek Pharmaceuticals
18 1Livmore Life Sciences
19 2Macleods Pharmaceuticals Limited
20 3Maithri Drugs
21 2Mangalam Drugs & Organics Ltd
22 2Mankind Pharma
23 2Omsav Pharma Research
24 1Osmopharm
25 1PCA - Prodotti Chimicie Alimentari S.p.A
26 1Roche Diagnostics GmbH
27 1SKVen Technologies Pvt. Ltd
28 1Sandoz B2B
29 1Srini Pharmaceuticals
30 1Tecoland Corporation
31 1Tooba Pharmaceuticals
32 1Tyche Industries Ltd
33 4Unimark Remedies Limited
34 1Viatris
35 1Zim Laboratories
01 3China
02 2Finland
03 1Germany
04 30India
05 2Ireland
06 2Israel
07 4Italy
08 1Latvia
09 1Slovenia
10 2Switzerland
11 5U.S.A
01 26Active
02 8Inactive
03 19Blank
01 2Suspended by Holder
02 12Valid
03 1Withdrawn by EDQM Failure to CEP procedure
04 1Withdrawn by Holder
05 37Blank
01 53Blank
01 1WC-0037
02 1WC-0170
03 1WC-0231A4
04 1WC-0407a4
05 1WC-0416
06 1WC-0473
07 1WC-476
08 46Blank
ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38079
Submission : 2023-05-10
Status : Active
Type : II
Date of Issue : 2024-01-23
Valid Till : 2026-06-17
Written Confirmation Number : WC-476
Address of the Firm :
NDC Package Code : 84668-015
Start Marketing Date : 2024-08-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-01-15
Pay. Date : 2019-11-05
DMF Number : 33838
Submission : 2019-10-15
Status : Active
Type : II
Certificate Number : R0-CEP 2019-206 - Rev 02
Issue Date : 2023-03-16
Type : Chemical
Substance Number : 101
Status : Valid
Available Reg Filing : ASMF |
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-038
Start Marketing Date : 2020-08-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Date of Issue : 2022-06-08
Valid Till : 2025-06-16
Written Confirmation Number : WC-0037
Address of the Firm :
ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38080
Submission : 2023-05-10
Status : Active
Type : II
NDC Package Code : 84668-015
Start Marketing Date : 2024-08-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
We have 35 companies offering Nitrofurantoin, Monohydrate
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