LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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01 1LGM Pharma
02 1Metrochem API Private Limited
03 3Dr. Reddy's Laboratories
04 1Jai Radhe Sales
05 1Shandong Chenghui Shuangda Pharmaceutical
06 1HRV Pharma
07 1Tagoor Laboratories
08 1Honour Lab Limited
09 1APOTECNIA SA
10 1Aarti Drugs
11 2Alivus Life Sciences
12 2Amino Chemicals
13 1Aurobindo Pharma Limited
14 1CHEMO
15 1Chr. Olesen Synthesis A.S
16 1Chromo Laboratories
17 2Cipla
18 1Daebong
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20 4Derivados Quimicos SAU
21 1DongWoo Syntech
22 1Ercros
23 1F.I.S. Fabbrica Italiana Sintetici
24 1Gedeon Richter
25 1Glenmark Pharmaceuticals
26 2Hetero Drugs
27 1Hy-Gro Chemicals
28 1Inist
29 1Kalchem International
30 1Letco Medical
31 1MSN Laboratories
32 2Medisca
33 1Nishchem International Pvt. Ltd
34 1Novartis Pharmaceuticals Corporation
35 2Olon S.p.A
36 1Orchid Pharma
37 2Pcca
38 1Permachem Asia, Ltd
39 1Perrigo API India Private Limited
40 1Qilu Antibiotics Pharmaceutical Co., Ltd.
41 1Qilu Pharmaceutical
42 1Qingdao Qingmei Biotech
43 1Quimica Sintetica
44 1Recordati
45 1Saneca Pharmaceuticals
46 1Saptagir Laboratories
47 4Shandong Anhong Pharmaceutical
48 1Shandong Boyuan Pharmaceutical
49 1Shouyuan Chemical
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51 1Suvan Lifesciences
52 2Synergene Active Ingredients Pvt Ltd
53 2Taro Pharmaceutical Industries
54 1Tianjin Weijie Pharmaceutical Co., Ltd.
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58 19Zhejiang Medicine Co Ltd
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01 30China
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05 28India
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11 8Spain
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01 21Active
02 5Inactive
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01 19Valid
02 6Withdrawn by Holder
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01 1217MF11144
02 1218MF10192
03 1218MF10443
04 1218MF10711
05 1218MF10830
06 1219MF10253
07 1220MF10173
08 1221MF10044
09 1222MF10168
10 1223MF10017
11 1224MF10131
12 1226MF10105
13 1301MF10056
14 1303MF10046
15 1303MF10062
16 1303MF10155
17 1305MF10069
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01 1WC-0021
02 1WC-0035
03 1WC-0041
04 1WC-0057n
05 1WC-0120
06 1WC-0140
07 1WC-0141
08 1WC-0362
09 1WC-0433
10 1WC-0465
11 1WC-0472
12 1WC-0494
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01 120050831-49-A-88-01
02 120050831-49-A-89-02
03 120050831-49-A-95-05
04 120050831-49-A-98-08
05 120050831-49-A-99-09
06 120050831-49-A-99-09(1)
07 120050831-49-A-99-09(5)
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09 120050905-49-A-94-10(1)
10 120050905-49-A-94-10(2)
11 120050905-49-A-94-10(3)
12 120050905-49-A-94-10(6)
13 120050905-49-A-94-10(7)
14 120120912-49-A-267-17
15 120140721-49-A-299-19
16 120140721-49-A-299-19(1)
17 120140721-49-A-299-19(2)
18 120140721-49-A-299-19(3)
19 120140721-49-A-299-19(4)
20 120190118-49-A-352-20
21 120190322-49-A-349-21
22 120190322-49-A-349-21(1)
23 120190322-49-A-349-21(10)
24 120190322-49-A-349-21(11)
25 120190322-49-A-349-21(12)
26 120190322-49-A-349-21(13)
27 120190322-49-A-349-21(2)
28 120190322-49-A-349-21(3)
29 120190322-49-A-349-21(5)
30 120190322-49-A-349-21(6)
31 120190322-49-A-349-21(7)
32 120190322-49-A-349-21(8)
33 120190322-49-A-349-21(9)
34 120221215-49-A-375-22
35 120221220-49-A-376-23
36 120250730-49-A-395-24
37 120251210-49-A-400-25
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01 114501-0012
02 138779-2481
03 138779-3253
04 148087-0079
05 149386-007
06 151927-0367
07 151927-4856
08 152286-0007
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10 153069-0530
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14 159349-0037
15 159349-0038
16 160592-023
17 162991-3085
18 165862-364
19 166039-817
20 166039-859
21 168554-0002
22 169037-0049
23 170159-006
24 171052-010
25 70Blank
01 94Blank
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.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15887
Submission : 2002-03-06
Status : Active
Type : II
Date of Issue : 2025-05-28
Valid Till : 2028-06-25
Written Confirmation Number : WC-0035
Address of the Firm :
NDC Package Code : 55111-024
Start Marketing Date : 2002-03-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongwoo Chemical Co., Ltd.
Registration Date : 2014-07-07
Registration Number : 20050831-49-A-99-09(5)
Manufacturer Name : Dr. Reddy's Laboratories Ltd
Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram, Jinnaram Mandal, Sangareddy District, Telangana, India
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0362
Address of the Firm :
NDC Package Code : 69037-0049
Start Marketing Date : 1996-05-10
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2011-06-15
Registration Number : 20050831-49-A-99-09(1)
Manufacturer Name : Dr. Reddy\'s Laboratories Ltd.
Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram, Jinnaram Mandal, Sangareddy District, Telangana, India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-49-A-99-09
Manufacturer Name : Dr. Reddy\'s Laboratories Ltd.
Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram, Jinnaram Mandal, Sangareddy District, Telangana, India
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A Terbisil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Terbisil, including repackagers and relabelers. The FDA regulates Terbisil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Terbisil API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Terbisil supplier is an individual or a company that provides Terbisil active pharmaceutical ingredient (API) or Terbisil finished formulations upon request. The Terbisil suppliers may include Terbisil API manufacturers, exporters, distributors and traders.
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