Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
01 1Gonane Pharma
02 1LGM Pharma
03 1Metrochem API Private Limited
04 1Dr. Reddy's Laboratories
05 1Egis Pharmaceuticals PLC
06 1Jai Radhe Sales
07 1Shandong Chenghui Shuangda Pharmaceutical
08 1HRV Global Life Sciences
09 2Neuland Laboratories
10 1Octavius Pharma Pvt. Ltd
11 1USV Private Limited
12 1TAPI Technology & API Services
13 3Alembic Pharmaceuticals Limited
14 1Apotex Pharmachem
15 1Aspire Lifesciences Pvt Ltd
16 1Aurobindo Pharma Limited
17 1Beloorbayir Biotech
18 1Boryung Pharmaceutical Co., Ltd
19 1CHEMO
20 1Cadila Pharmaceuticals
21 2Cipla
22 1Curequest Lifescience
23 1Eisai
24 1FineTech Pharmaceutical Ltd.
25 1Grand Health Industrial Co Ltd
26 1Green Stone Swiss Co ., Ltd
27 1Guangzhou Tosun Pharmaceutical
28 1Hengdian Group
29 1Hermes Chemical
30 2Hetero Drugs
31 1Hikal
32 1Ind Swift Laboratories Limited
33 1Ipca Laboratories
34 1JRC
35 2Jubilant Generics
36 1Jubilant Pharmova
37 1KOLON Life Science, Inc
38 1Lupin Ltd
39 1Macleods Pharmaceuticals Limited
40 2Megafine Pharma (P) Limited
41 1Nosch Labs Pvt
42 2Perrigo API India Private Limited
43 1Piramal Pharma Solutions
44 1Pliva Hrvatska
45 1RANBAXY LABORATORIES LIMITED
46 1Rumit Group of Companies
47 2Ryoto Fine Co
48 2Sun Pharmaceutical Industries Limited
49 1Synthimed Labs
50 1Teva Pharmaceutical Industries
51 1Therapiva
52 1Torrent Pharmaceuticals Limited
53 1Unichem Laboratories Limited
54 1Vasudha Pharma Chem
55 1Weihai Disu Pharmacuetical Co., Ltd.
56 1Wockhardt
57 1Yoshindo
58 1Yuki Gosei Kogyo
59 2Zhejiang East Asia Pharmaceutical
60 1Zhejiang Hisun Pharmaceutical
61 2Zhejiang Huahai Pharmaceutical
62 1Zydus Lifesciences
01 1Canada
02 11China
03 1Croatia
04 1Hungary
05 47India
06 3Israel
07 5Japan
08 2South Korea
09 1Spain
10 2U.S.A
01 26Active
02 6Inactive
03 42Blank
01 11Valid
02 63Blank
01 1222MF10154
02 1222MF10156
03 1222MF10164
04 1222MF10165
05 1222MF10172
06 1222MF10180
07 1222MF10181
08 1222MF10184
09 1222MF10189
10 1222MF10202
11 1227MF10005
12 1227MF10288
13 1230MF10032
14 1230MF10046
15 1302MF10149
16 1303MF10149
17 58Blank
01 1WC-0003
02 1WC-0011nA2
03 1WC-0012
04 1WC-0026
05 1WC-0027
06 1WC-0036
07 1WC-0040
08 1WC-0063
09 1WC-0070
10 1WC-0075a3
11 1WC-0079
12 1WC-0082
13 1WC-0082A14
14 1WC-0082A3
15 1WC-0084
16 1WC-0087-(Annexure-1)
17 1WC-0092
18 1WC-0092A
19 1WC-0113
20 1WC-0120
21 1WC-0123
22 1WC-0159
23 1WC-0462
24 51Blank
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
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 : Reviewed
Rev. Date : 2014-10-31
Pay. Date : 2014-10-27
DMF Number : 17779
Submission : 2004-10-26
Status : Active
Type : II
NDC Package Code : 55111-074
Start Marketing Date : 2004-10-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2013-04-26
Registration Number : 20130409-158-I-79-13(1)
Manufacturer Name : Dr. Reddy's Laboratories Limited
Manufacturer Address : Plot No. 9/A, Phase-III, IDA Jeedimetla, Ranga Reddy District, Andhra Pradesh
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Shuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-01-28
Pay. Date : 2020-01-21
DMF Number : 21132
Submission : 2007-12-11
Status : Active
Type : II
Certificate Number : CEP 2019-311 - Rev 01
Issue Date : 2024-01-31
Type : Chemical
Substance Number : 3067
Status : Valid
Date of Issue : 2022-07-28
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
NDC Package Code : 58032-0137
Start Marketing Date : 2017-11-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Terrazen ITEX Co., Ltd.
Registration Date : 2019-11-22
Registration Number : 20141008-158-I-439-23(11)
Manufacturer Name : Neuland Laboratories Ltd.
Manufacturer Address : Unit-I, Sy. No: 347, 473, 474, 490/2, Bonthapally Village, Veerabhadraswamy Temple Road, Gummadidala Mandal, Sangareddy District - 502 313, Telangana State, India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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