Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
01 1Laboratorium Ofichem B.V
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1LGM Pharma
04 1Dr. Reddy's Laboratories
05 1Faran Shimi Pharmaceutical
06 1HRV Global Life Sciences
07 1Tofigh Daru
08 1Granules India Limited
09 2TAPI Technology & API Services
10 1Alkem Laboratories
11 1Almelo
12 1Alven Laboratories
13 1Amoli Organics
14 1Arevipharma
15 1Aspire Lifesciences Pvt Ltd
16 1Aurobindo Pharma Limited
17 1Chongqing Huapont Pharmaceutical
18 1Dishman Carbogen Amcis
19 2Enaltec Labs Private Limited
20 1Glenmark Life Sciences
21 1Glenmark Pharmaceuticals
22 1Guangzhou Tosun Pharmaceutical
23 1HONOUR LAB LTD
24 1Hetero Drugs
25 1Intas Pharmaceuticals
26 2MSN Laboratories
27 1Macleods Pharmaceuticals Limited
28 1Micro Labs Limited
29 1Natco Pharma
30 1Optimus Pharma
31 1Parsian Pharamceutical
32 1Pellets Pharma Limited
33 1Precise Group
34 1Raks Pharma
35 1Shilpa Medicare
36 1Sionc Pharmaceuticals
37 1Sun Pharmaceutical Industries Limited
38 1Teva Pharmaceutical Industries
39 1Titan Laboratories
40 1Torrent Pharmaceuticals Limited
41 1Unichem Laboratories Limited
42 2Vasudha Pharma Chem
43 1Viatris
44 1Yabao Pharmaceutical Group Co. Ltd
45 2Zhejiang Huahai Pharmaceutical
46 1Zim Laboratories
47 1Zydus Lifesciences
01 5China
02 1Czech Republic
03 1Germany
04 36India
05 3Iran
06 3Israel
07 1Netherlands
08 2U.S.A
01 27Active
02 2Inactive
03 23Blank
01 52Blank
01 52Blank
01 1WC-0024
02 1WC-0062
03 1WC-0077A4
04 1WC-0147A3
05 1WC-0157
06 1WC-0168
07 1WC-0182
08 1WC-0183A3-4
09 1WC-0183nA2
10 1WC-0225A6
11 1WC-0273
12 1WC-0281A3
13 1WC-0281new2
14 1WC-0310
15 1WC-0362
16 1WC-0544
17 36Blank
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-21
Pay. Date : 2016-10-26
DMF Number : 31053
Submission : 2017-01-12
Status : Active
Type : II
NDC Package Code : 62675-0393
Start Marketing Date : 2018-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2022-06-21
Registration Number : Su234-3-ND
Manufacturer Name : Laboratorium Ofichem BV
Manufacturer Address : Heembadweg 5, Ter Apel, 9561CZ, Netherlands
Available Reg Filing : ASMF |
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-07-02
Pay. Date : 2015-04-01
DMF Number : 28955
Submission : 2015-01-09
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
NDC Package Code : 55111-997
Start Marketing Date : 2015-03-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-27
Pay. Date : 2017-04-12
DMF Number : 30938
Submission : 2016-09-27
Status : Active
Type : II
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm :
NDC Package Code : 62207-003
Start Marketing Date : 2018-06-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ROW |
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-09-23
Pay. Date : 2016-07-06
DMF Number : 29913
Submission : 2016-08-31
Status : Active
Type : II
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-22
Pay. Date : 2016-09-26
DMF Number : 30936
Submission : 2016-09-29
Status : Active
Type : II
Available Reg Filing : ASMF |
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