LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Shanghai Minbiotech
03 1ChemWerth Inc
04 1DKSH
05 1Octavius Pharma Pvt. Ltd
06 1Farmhispania
07 1Fishfa Biogenics
08 2Chunghwa Chemical Synthesis & Biotech
09 1Beijing Mesochem Technology
10 1ABRAXIS BIOSCIENCE
11 1Abbott Laboratories
12 1Alkermes Plc
13 1Apotex Fermentation Inc.
14 1Artis Biotech
15 1Aurisco Pharmaceutical
16 1Biocon
17 1BrightGene Bio-Medical Technology Co.,Ltd
18 1Chongqing DaXin Pharmaceutical
19 1Concord Biotech
20 1Curia
21 1Fujian Kerui Pharmaceutical Co Ltd
22 1Guangzhou Topwork Chemical
23 1Guangzhou Tosun Pharmaceutical
24 1Hangzhou Longshine Bio-Tech
25 1Hangzhou Zhongmei Huadong Pharmaceutical
26 1Hanways Chempharm
27 1Heilongjiang Weikang Bio-Tech
28 1Hubei Honch Pharmaceutical
29 1Hubei Vanz Pharm
30 1Jiwan Pharmaceutical Technology Co., Ltd
31 1Lek Pharmaceuticals
32 2Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
33 1Lonza Group
34 2Lunan Pharmaceutical
35 1Murli Krishna Pharma
36 1Orchestra Biomed
37 1Sajjala Bio Labs
38 1Sandoz B2B
39 1Selecta Biosciences
40 1Sun-shine Chem
41 1Synthland
42 1Tecoland Corporation
43 1TriviumVet
44 1Unipex
45 1WORLD JIANGSU INDUSTRY CO LTD
46 1Wyeth Pharmaceuticals Inc
47 2Zhejiang Hisun Pharmaceutical
48 1Blank
01 1Canada
02 24China
03 1France
04 7India
05 2Ireland
06 1Slovenia
07 1Spain
08 3Switzerland
09 2Taiwan
10 9U.S.A
11 1Blank
01 21Active
02 9Inactive
03 22Blank
01 52Blank
01 1224MF10198
02 1225MF10176
03 1302MF10039
04 1303MF10065
05 48Blank
01 1WC-0109A
02 1WC-0111
03 50Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17399
Submission : 2004-05-20
Status : Active
Type : II
Registration Number : 224MF10198
Registrant's Address : No. 1, Tung-Hsing St. , Shu-Lin, New Taipei City 23850, Taiwan
Initial Date of Registration : 2012-09-13
Latest Date of Registration : --
NDC Package Code : 52076-6216
Start Marketing Date : 2016-04-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Santen Pharmaceutical Co., Ltd.
Registration Date : 2017-05-16
Registration Number : 20170516-190-I-542-03
Manufacturer Name : Chunghwa Chemical Synthesis & Biotech Co., Ltd. Shanjia Plant
Manufacturer Address : 1, Tung-Hsing St. Shu-Lin, New Taipei City 23850, Taiwan
Available Reg Filing : ASMF |
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-03
Pay. Date : 2017-01-04
DMF Number : 31189
Submission : 2016-12-30
Status : Active
Type : II
Registration Number : 303MF10065
Registrant's Address : No. 1, Tung-Hsing St. , Shu-Lin, New Taipei City 23850, Taiwan
Initial Date of Registration : 2021-04-13
Latest Date of Registration : --
NDC Package Code : 52076-6216
Start Marketing Date : 2016-04-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Santen Pharmaceutical Co., Ltd.
Registration Date : 2017-05-16
Registration Number : 20170516-190-I-542-03
Manufacturer Name : Chunghwa Chemical Synthesis & Biotech Co., Ltd. Shanjia Plant
Manufacturer Address : 1, Tung-Hsing St. Shu-Lin, New Taipei City 23850, Taiwan
Available Reg Filing : ASMF |
A Sirolimus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sirolimus, including repackagers and relabelers. The FDA regulates Sirolimus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sirolimus 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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