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 1Alkem Laboratories
10 1Almelo
11 1Alven Laboratories
12 1Amoli Organics
13 1Arevipharma
14 1Aspire Lifesciences Pvt Ltd
15 1Aurobindo Pharma Limited
16 1Chongqing Huapont Pharmaceutical
17 1Dishman Carbogen Amcis
18 2Enaltec Labs Private Limited
19 1Glenmark Life Sciences
20 1Glenmark Pharmaceuticals
21 1Guangzhou Tosun Pharmaceutical
22 1HONOUR LAB LTD
23 1Hetero Drugs
24 1Intas Pharmaceuticals
25 2MSN Laboratories
26 1Macleods Pharmaceuticals Limited
27 1Micro Labs Limited
28 1Natco Pharma
29 1Optimus Pharma
30 1Parsian Pharamceutical
31 1Pellets Pharma Limited
32 1Precise Group
33 1Raks Pharma
34 1Shilpa Medicare
35 1Sionc Pharmaceuticals
36 1Sun Pharmaceutical Industries Limited
37 2Teva API
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-0077A4
03 1WC-0147A3
04 1WC-0157
05 1WC-0182
06 1WC-0183A3-4
07 1WC-0183nA2
08 1WC-0225A6
09 1WC-0273
10 1WC-0281A3
11 1WC-0281new2
12 1WC-0310
13 1WC-0362
14 1WC-0544
15 38Blank
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 : 2016-03-25
Pay. Date : 2015-08-31
DMF Number : 29632
Submission : 2015-11-03
Status : Active
Type : II
Date of Issue : 2022-11-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0182
Address of the Firm :
NDC Package Code : 59285-003
Start Marketing Date : 2014-12-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-25
Pay. Date : 2015-07-08
DMF Number : 29485
Submission : 2015-07-23
Status : Active
Type : II
Date of Issue : 2019-07-26
Valid Till : 2022-05-05
Written Confirmation Number : WC-0362
Address of the Firm :
NDC Package Code : 69037-0012
Start Marketing Date : 2013-03-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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