ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1LGM Pharma
03 1DKSH
04 1Dr. Reddy's Laboratories
05 1Chongqing Sintaho Pharmaceutical
06 1HRV Global Life Sciences
07 1Archimica
08 1Ash Stevens, Inc.
09 1Aspire Lifesciences Pvt Ltd
10 1Aurobindo Pharma Limited
11 1Beijing Fukangren Biopharmaceutical
12 1DEAFARMA
13 1Fujian South Pharmaceutical
14 1Guangzhou Tosun Pharmaceutical
15 1Hansoh Pharma
16 1Hetero Drugs
17 1ITF CHEMICAL LTDA
18 2Intas Pharmaceuticals
19 1Jeil Pharmaceutical Co., Ltd
20 1Laurus Labs
21 1MSN Laboratories
22 1Mac-Chem Products (India) Pvt.Ltd
23 1Olon S.p.A
24 1Polymed Therapeutics Inc.
25 1Qilu Antibiotics Pharmaceutical Co., Ltd.
26 1Reliance Life Sciences Private Limited
27 1Sakar Healthcare
28 1ScinoPharm Taiwan, Ltd
29 1Shilpa Medicare
30 1Sun Pharmaceutical Industries Limited
31 1TAPI Technology & API Services
32 1Teva Pharmaceutical Industries
33 1Vannsh Life Sciences
34 1Viatris
35 1Yangtze River Pharmaceutical Group
36 2Blank
01 1Brazil
02 7China
03 15India
04 2Israel
05 3Italy
06 1South Korea
07 1Switzerland
08 1Taiwan
09 5U.S.A
10 2Blank
01 17Active
02 4Inactive
03 17Blank
01 38Blank
01 1301MF10047
02 1302MF10075
03 1303MF10033
04 35Blank
01 1WC-0039
02 1WC-0147
03 1WC-0213
04 1WC-0349
05 1WC-0440
06 1WC-0440A1
07 32Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-26
Pay. Date : 2022-12-16
DMF Number : 23416
Submission : 2009-12-22
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.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-20
Pay. Date : 2020-11-17
DMF Number : 23564
Submission : 2010-02-23
Status : Active
Type : II
Registration Number : 302MF10075
Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA
Initial Date of Registration : 2020-07-01
Latest Date of Registration : --
Date of Issue : 2022-06-06
Valid Till : 2025-07-07
Written Confirmation Number : WC-0039
Address of the Firm :
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2017-09-29
Registration Number : Su249-4-ND
Manufacturer Name : Dr. Reddy's Laboratories Limited
Manufacturer Address : Chemical Technical Operations-Unit I, Plot Nos. 137, 138, 145 & 146 Sri Venkateswara Co-operative industrial Estate, Bollaram Village, Jinnaram Mandal Sangareddy District, Telangana, India. Pin Code – 502 325
NDC Package Code : 84172-112
Start Marketing Date : 2024-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, FOR SOLUTION (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-04-04
Pay. Date : 2012-11-29
DMF Number : 22360
Submission : 2008-12-31
Status : Active
Type : II
NDC Package Code : 65129-1222
Start Marketing Date : 2004-04-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-15
Pay. Date : 2013-09-23
DMF Number : 27487
Submission : 2013-09-23
Status : Active
Type : II
Registration Number : 303MF10033
Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584135, Karnataka, India
Initial Date of Registration : 2021-02-16
Latest Date of Registration : --
Date of Issue : 2019-07-05
Valid Till : 2022-07-02
Written Confirmation Number : WC-0147
Address of the Firm :
NDC Package Code : 82920-015
Start Marketing Date : 2022-08-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samyang Holdings Co., Ltd.
Registration Date : 2018-06-25
Registration Number : No. 163-15-ND(1)
Manufacturer Name : Shilpa Medicare Limited
Manufacturer Address : Plot No.33, 33A, 40 to 47, Block C,D,E,H,I & AM, Raichur Industrial Growth Centre, Chicksugur - 584 134 Dist: Raichur, Karnataka India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3562
Submission : 1979-07-09
Status : Inactive
Type : II
Registrant Name : Korea BMS Pharmaceutical Co., Ltd.
Registration Date : 2010-07-30
Registration Number : No. 5284-1-ND
Manufacturer Name : Ash Stevens LLC.
Manufacturer Address : 18655 Krause St., Riverview, MI 48193
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25265
Submission : 2011-09-07
Status : Inactive
Type : II
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