ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Polpharma
03 1LGM Pharma
04 1DKSH
05 1Dr. Reddy's Laboratories
06 1Chongqing Sintaho Pharmaceutical
07 1HRV Global Life Sciences
08 1Archimica
09 1Ash Stevens, Inc.
10 1Aspire Lifesciences Pvt Ltd
11 1Aurobindo Pharma Limited
12 1Beijing Fukangren Biopharmaceutical
13 1DEAFARMA
14 1Fujian South Pharmaceutical
15 1Guangzhou Tosun Pharmaceutical
16 1Hansoh Pharma
17 1Hetero Drugs
18 1ITF CHEMICAL LTDA
19 2Intas Pharmaceuticals
20 1Jeil Pharmaceutical Co., Ltd
21 1Laurus Labs
22 1MSN Laboratories
23 1Mac-Chem Products (India) Pvt.Ltd
24 1Olon S.p.A
25 1Polymed Therapeutics Inc.
26 1Qilu Antibiotics Pharmaceutical Co., Ltd.
27 1Reliance Life Sciences Private Limited
28 1Sakar Healthcare
29 1ScinoPharm Taiwan, Ltd
30 1Shilpa Medicare
31 1Sun Pharmaceutical Industries Limited
32 1Teva API
33 1Teva Pharmaceutical Industries
34 1Vannsh Life Sciences
35 1Viatris
36 1Yangtze River Pharmaceutical Group
37 2Blank
01 1Brazil
02 7China
03 15India
04 2Israel
05 3Italy
06 1Poland
07 1South Korea
08 1Switzerland
09 1Taiwan
10 5U.S.A
11 2Blank
01 17Active
02 4Inactive
03 18Blank
01 39Blank
01 1301MF10047
02 1302MF10075
03 1303MF10033
04 36Blank
01 1WC-0039
02 1WC-0147
03 1WC-0213
04 1WC-0349
05 1WC-0440
06 1WC-0440A1
07 33Blank
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
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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
Available Reg Filing : BR, EU, CA, RU |
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 : 2013-10-24
Pay. Date : 2012-11-13
DMF Number : 26126
Submission : 2012-06-04
Status : Active
Type : II
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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