01 2ACS DOBFAR SPA
02 1Asia Pioneer Pharmaceuticals
03 1CordenPharma
04 1Fresenius Kabi Anti-Infectives
05 2Lupin Ltd
06 2NCPC Hebei Huamin Pharmaceutical
07 2Nectar Lifesciences
08 1Novartis Pharmaceuticals Corporation
09 3Orchid Pharma
10 1Orchidia Pharmaceutical Ind.
11 1Qilu Antibiotics Pharmaceutical Co., Ltd.
12 1SHENZHEN SALUBRIS PHARMACEUTICALS
01 4China
02 1Egypt
03 1Germany
04 7India
05 3Italy
06 1Switzerland
07 1U.S.A
01 7Active
02 2Inactive
03 9Blank
01 1Valid
02 17Blank
01 1220MF10160
02 1220MF10161
03 1220MF10223
04 1220MF10254
05 1228MF10166
06 1228MF10233
07 1229MF10015
08 1230MF10013
09 10Blank
01 1WC-0131
02 1WC-0131-A
03 1WC-0131N
04 1WC0131
05 14Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18902
Submission : 2005-10-24
Status : Active
Type : II
Registration Number : 220MF10160
Registrant's Address : Orchid Towers, 313, Valuvar Kottam High Road, Nungambakkam, Chennai-600 034, India
Initial Date of Registration : 2008-07-10
Latest Date of Registration : --
Date of Issue : 2019-07-22
Valid Till : 2022-07-21
Written Confirmation Number : WC-0131
Address of the Firm :
Registrant Name : Korea Pfizer Pharmaceutical PFE Co., Ltd.
Registration Date : 2016-06-29
Registration Number : 20131031-84-D-126-07(1)
Manufacturer Name : Orchid Chemicals & Pharmaceuticals Ltd.,
Manufacturer Address : Plot Nos. 121-128, 128A-133, 138-151, 159-164, SIDCO Industrial Estate, Alathur -603 110 Kancheepuram District, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25443
Submission : 2011-11-28
Status : Active
Type : II
Registration Number : 220MF10161
Registrant's Address : Orchid Towers, 313, Valuvar Kottam High Road, Nungambakkam, Chennai-600 034, India
Initial Date of Registration : 2008-07-10
Latest Date of Registration : --
Date of Issue : 2019-08-16
Valid Till : 2022-07-21
Written Confirmation Number : WC-0131-A
Address of the Firm :
Registrant Name : Korea Pfizer Pharmaceutical PFE Co., Ltd.
Registration Date : 2016-06-29
Registration Number : 20131031-84-D-126-07(1)
Manufacturer Name : Orchid Chemicals & Pharmaceuticals Ltd.,
Manufacturer Address : Plot Nos. 121-128, 128A-133, 138-151, 159-164, SIDCO Industrial Estate, Alathur -603 110 Kancheepuram District, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-01
Pay. Date : 2014-03-04
DMF Number : 27971
Submission : 2014-01-20
Status : Active
Type : II
Certificate Number : CEP 2022-460 - Rev 00
Issue Date : 2023-09-13
Type : Chemical
Substance Number : 2126
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25016
Submission : 2012-02-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25017
Submission : 2011-12-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19798
Submission : 2006-09-26
Status : Active
Type : II
NDC Package Code : 52946-0837
Start Marketing Date : 2009-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19927
Submission : 2006-11-01
Status : Active
Type : II
NDC Package Code : 52946-0837
Start Marketing Date : 2009-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2019-08-16
Valid Till : 2022-07-21
Written Confirmation Number : WC-0131N
Address of the Firm :
Registrant Name : Korea Pfizer Pharmaceutical PFE Co., Ltd.
Registration Date : 2016-06-29
Registration Number : 20131031-84-D-126-07(1)
Manufacturer Name : Orchid Chemicals & Pharmaceuticals Ltd.,
Manufacturer Address : Plot Nos. 121-128, 128A-133, 138-151, 159-164, SIDCO Industrial Estate, Alathur -603 110 Kancheepuram District, India
Date of Issue : 2019-07-22
Valid Till : 2022-07-20
Written Confirmation Number : WC0131
Address of the Firm :
NDC Package Code : 63785-113
Start Marketing Date : 2010-07-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
Registrant Name : KR Pharm Co., Ltd.
Registration Date : 2021-01-21
Registration Number : 20210121-84-D-156-11
Manufacturer Name : Orchid Pharma Limited
Manufacturer Address : Plot Nos. 121-128, 128A-133, 138-151 & 159-164, SIDCO Industrial Estate, Alathur, Chengalpattu District-603 110, India
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