Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1LGM Pharma
03 1Metrochem API Private Limited
04 1Inabata France S.A.S
05 1Faran Shimi Pharmaceutical
06 1HRV Global Life Sciences
07 1Tofigh Daru
08 2Alembic Pharmaceuticals Limited
09 1Aurobindo Pharma Limited
10 1Biocon
11 1DEAFARMA
12 1Deva Holding AS
13 1Emcure Pharmaceuticals
14 1Enaltec Labs Private Limited
15 1Formosa Laboratories
16 1Glenmark Life Sciences
17 1Glenmark Pharmaceuticals
18 1Guangzhou Tosun Pharmaceutical
19 1HONOUR LAB LTD
20 1Hangzhou Longshine Bio-Tech
21 1Hetero Drugs
22 1Intas Pharmaceuticals
23 1KIVIPharm
24 1MSN Laboratories
25 1Maprimed
26 1Megafine Pharma (P) Limited
27 1Mehta API
28 1Natco Pharma
29 1Olon S.p.A
30 1Optimus Pharma
31 1Parsian Pharamceutical
32 1Pramukh Pharmachem
33 1Raks Pharma
34 2Saba Ilac Sanayii Ve Ticaret
35 1Sajjala Bio Labs
36 1Shilpa Medicare
37 1Tianjin Weijie Pharmaceutical Co., Ltd.
38 1Unichem Laboratories Limited
39 1Zydus Lifesciences
01 1Argentina
02 4China
03 1France
04 1Germany
05 24India
06 3Iran
07 2Italy
08 1Taiwan
09 3Turkey
10 1U.S.A
01 20Active
02 21Blank
01 14Valid
02 27Blank
01 41Blank
01 1WC-0014
02 1WC-0019A3
03 1WC-0021n
04 1WC-0063
05 1WC-0081
06 1WC-0081A4
07 1WC-0087-(Annexure-1)
08 1WC-0310
09 33Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-03
Pay. Date : 2016-02-19
DMF Number : 30220
Submission : 2016-03-10
Status : Active
Type : II
Certificate Number : CEP 2023-073 - Rev 00
Issue Date : 2024-07-25
Type : Chemical
Substance Number : 3036
Status : Valid
Date of Issue : 2022-07-15
Valid Till : 2025-05-28
Written Confirmation Number : WC-0019A3
Address of the Firm :
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Tofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-11-06
Pay. Date : 2015-09-08
DMF Number : 29701
Submission : 2015-10-01
Status : Active
Type : II
NDC Package Code : 69037-0016
Start Marketing Date : 2012-09-12
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 : 30978
Submission : 2016-11-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36653
Submission : 2021-12-23
Status : Active
Type : II
Certificate Number : CEP 2022-254 - Rev 00
Issue Date : 2024-02-28
Type : Chemical
Substance Number : 3036
Status : Valid
NDC Package Code : 59285-001
Start Marketing Date : 2014-04-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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