Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.

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01 1Apex Healthcare Limited
02 1LGM Pharma
03 1Jai Radhe Sales
04 1Pharm-RX Chemical
05 1Tenatra Exports
06 1Zeon Pharma Industries India Pvt Ltd
07 1Zeal Medipharma
08 1JPN Pharma
09 1SNJ Labs
10 2Bidachem
11 1Biesterfeld Spezialchemie GmbH
12 1CARBOGEN AMCIS AG
13 1Cambrex Corporation
14 1Dishman Carbogen Amcis
15 1Dr. Raju’s Pharma Solutions
16 1Erregierre SpA
17 1Guangzhou Tosun Pharmaceutical
18 3Kreative Organics
19 1Nippi
20 1Rakshit Drugs
21 1Reliance Rasayan
22 1Shreepati Pharmaceuticals
23 1Stason Pharmaceuticals, Inc.
24 1Blank
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01 1China
02 1Germany
03 14India
04 3Italy
05 1Japan
06 1Switzerland
07 5U.S.A
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01 5Active
02 22Blank
01 5Valid
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01 1217MF10614
02 1218MF10142
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01 1WC-0136
02 1WC-0180
03 1WC-0409
04 2WC-0599
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01 27Blank
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01 112828-0015
02 149706-0650
03 151927-0115
04 158793-002
05 161876-0002
06 169617-008
07 183221-001
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01 27Blank
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36474
Submission : 2022-01-27
Status : Active
Type : II
Date of Issue : 2024-03-01
Valid Till : 2026-12-31
Written Confirmation Number : WC-0409
Address of the Firm :
NDC Package Code : 69617-008
Start Marketing Date : 2019-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14947
Submission : 2000-06-29
Status : Active
Type : II
Certificate Number : R0-CEP 2020-233 - Rev 00
Issue Date : 2022-03-01
Type : Chemical
Substance Number : 595
Status : Valid
NDC Package Code : 49706-0650
Start Marketing Date : 2010-01-08
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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