LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1HRV Global Life Sciences
03 1Alembic Pharmaceuticals Limited
04 1Apotex Pharmachem
05 1Aurore Life Sciences
06 1Beijing Fukangren Biopharmaceutical
07 1Boryung Pharmaceutical Co., Ltd
08 1Chemi SpA
09 1Dipharma
10 1Guangzhou Tosun Pharmaceutical
11 1Haoyuan Chemexpress Co.Ltd
12 3Hetero Drugs
13 1Intas Pharmaceuticals
14 1Lek Pharmaceuticals
15 1Lupin Ltd
16 1MSN Laboratories
17 1Maithri Drugs
18 1Raks Pharma
19 1Sun Pharmaceutical Industries Limited
20 1Unichem Laboratories Limited
21 1Wockhardt
22 1Zydus Lifesciences
01 1Canada
02 3China
03 15India
04 2Italy
05 1Slovenia
06 1South Korea
07 1U.S.A
01 13Active
02 2Inactive
03 9Blank
01 24Blank
01 24Blank
01 1WC-0022
02 1WC-0066
03 1WC-0066A
04 1WC-0066new
05 1WC-0082
06 1WC-0455
07 18Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-04-03
Pay. Date : 2012-11-23
DMF Number : 26370
Submission : 2012-09-07
Status : Active
Type : II
Date of Issue : 2019-08-16
Valid Till : 2025-08-15
Written Confirmation Number : WC-0022
Address of the Firm :
NDC Package Code : 50370-0031
Start Marketing Date : 2012-06-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2017-12-05
Registration Number : Su258-4-ND
Manufacturer Name : MSN Pharmachem Private Limited
Manufacturer Address : Plot No.: 212 / A,B,C,D, Phase-II, IDAPashamylaram, Pashamylaram(Village), Patancheru(Mandal), Medak District, Telangana, Pincode: 502307, India.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-14
Pay. Date : 2012-10-26
DMF Number : 26503
Submission : 2012-10-13
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-04-26
Pay. Date : 2012-11-29
DMF Number : 26427
Submission : 2012-09-17
Status : Active
Type : II
Date of Issue : 2019-08-09
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm :
NDC Package Code : 65977-0093
Start Marketing Date : 2008-10-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-05-31
Registration Number : Su331-16-ND
Manufacturer Name : Hetero Drugs Limited
Manufacturer Address : Plot No. 1, Hetero Infrastructure SEZ Ltd, N.Narasapuram Village, Nakkapalli Mandal, Anakapalli District-531 081, Andhra Pradesh, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-19
Pay. Date : 2012-11-13
DMF Number : 26507
Submission : 2012-10-24
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-27
Pay. Date : 2012-10-26
DMF Number : 26392
Submission : 2012-08-30
Status : Active
Type : II
NDC Package Code : 47621-025
Start Marketing Date : 2012-08-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35679
Submission : 2021-03-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-09-17
Pay. Date : 2020-08-12
DMF Number : 33230
Submission : 2018-09-29
Status : Active
Type : II
Date of Issue : 2022-11-18
Valid Till : 2025-09-30
Written Confirmation Number : WC-0455
Address of the Firm :
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2020-11-25
Registration Number : Su258-12-ND
Manufacturer Name : Maithri Laboratories Private Limited
Manufacturer Address : Sy. No. 10/1 & 14, IDA Gaddapotharam, Gaddapotharam(Village), Jinnaram(Mandal), Sangareddy District, Pin code-502 319, Telangana State, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26491
Submission : 2012-09-27
Status : Inactive
Type : II
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