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 1HRV Global Life Sciences
06 1Tofigh Daru
07 1Granules India Limited
08 1Alkem Laboratories
09 1Almelo
10 1Alven Laboratories
11 1Amoli Organics
12 1Arevipharma
13 1Aspire Lifesciences Pvt Ltd
14 1Aurobindo Pharma Limited
15 1Chongqing Huapont Pharmaceutical
16 1Dishman Carbogen Amcis
17 2Enaltec Labs Private Limited
18 1Glenmark Life Sciences
19 1Glenmark Pharmaceuticals
20 1Guangzhou Tosun Pharmaceutical
21 1HONOUR LAB LTD
22 1Hetero Drugs
23 1Intas Pharmaceuticals
24 2MSN Laboratories
25 1Macleods Pharmaceuticals Limited
26 1Micro Labs Limited
27 1Natco Pharma
28 1Optimus Pharma
29 1Pellets Pharma Limited
30 1Precise Group
31 1Raks Pharma
32 1Shilpa Medicare
33 1Sionc Pharmaceuticals
34 1Sun Pharmaceutical Industries Limited
35 2Teva API
36 1Teva Pharmaceutical Industries
37 1Titan Laboratories
38 1Torrent Pharmaceuticals Limited
39 1Unichem Laboratories Limited
40 2Vasudha Pharma Chem
41 1Viatris
42 1Yabao Pharmaceutical Group Co. Ltd
43 2Zhejiang Huahai Pharmaceutical
44 1Zim Laboratories
45 1Zydus Lifesciences
01 5China
02 1Czech Republic
03 1Germany
04 36India
05 1Iran
06 3Israel
07 1Netherlands
08 2U.S.A
01 27Active
02 2Inactive
03 21Blank
01 50Blank
01 50Blank
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 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 : Number 234-3-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
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, ASMF |
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
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-02-08
Pay. Date : 2015-12-18
DMF Number : 30085
Submission : 2015-12-28
Status : Active
Type : II
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