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01 1Alchem International

02 1Axplora

03 1Farmabios S.p.A.

04 2PharmaZell (India) Private Limited

05 1PharmaZell GmbH

06 1Sichuan Credit Chemwerth Pharmaceutical Co. Ltd

07 1EUROAPI FRANCE

08 2EUROAPI France

09 1EUROAPI Germany GmbH

10 1EUROAPI Hungary Ltd.

11 1EUROAPI ITALY SRL

12 1EUROAPI UK Limited

13 1Interquim SA

14 1Minakem High Potent

15 1Delmar Chemicals Inc

16 1Zaklady Farmaceutyczne POLPHARMA SA

17 1SANOFI CHIMIE

18 1Sanofi

19 6Sanofi Chimie

20 1Sanofi India Limited

21 1Sanofi S.p.A.

22 1Sanofi S.r.l.

23 1Sanofi-Aventis Deutschland GmbH

24 2AbbVie INC

25 1Allergan Pharmaceuticals Ireland

26 1Allergan Sales LLC

27 1Biophore India Pharmaceuticals Pvt. Ltd

28 1INKE, S.A.

29 1LGM Pharma

30 1Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd.

31 1Zhejiang Hisoar Pharmaceutical Co., Ltd.

32 1Macfarlan Smith Limited

33 2Veranova, L.P.

34 1ZENARA PHARMA PRIVATE LIMITED

35 1Aspen Bad Oldesloe GmbH

36 1Aspen Oss B.V.

37 1Aspen SA OSD Operations (Pty) Ltd

38 1Aspen SA Sterile Operations

39 1Aspen Port Elizabeth (Pty) Ltd

40 1BACHEM SA

41 1Bachem AG

42 3Bachem Americas, Inc.

43 1Evonik Nutrition & Care GmbH

44 1Evonik Rexim (Nanning) Pharmaceutical Co., Ltd.

45 1Farmak A.S.

46 1Fermion Oy Hanko Plant

47 1Fermion Oy Oulu Plant

48 1Fine Chemicals Corporation (Pty) Ltd

49 2Nuray Chemicals Private Limited

50 2Orion Corporation

51 1PCAS

52 1PCAS Finland Oy

53 3SPI PHARMA

54 1CU Chemie Uetikon GmbH

55 1Novacyl

56 1Novacyl Thailand Limited

57 1Novacyl Wuxi Pharmaceutical Co. Ltd.

58 1PolyCarbon Industries, Inc.

59 1Suanfarma Italia

60 2SYMBIOTEC PHARMALAB PRIVATE LIMITED

61 1Perrigo Israel Pharmaceuticals LTD.

62 1Wavelength Enterprises Ltd.

63 1Astral SteriTech Private Limited

64 2Cohance Lifesciences

65 2RA CHEM PHARMA LIMITED

66 1ZCL Chemicals Limited

67 1Cayman Chemical Company, Inc

68 1Cayman Pharma s.r.o.

69 1Centrient Pharmaceuticals India Private Limited

70 1Centrient Pharmaceuticals Spain, SA

71 1Chemische Fabrik Berg GmbH

72 1Chirogate International Inc.

73 1CORAL DRUGS PRIVATE LIMITED

74 1Dr Reddy's Laboratories Limited

75 1Dr. Reddy's Laboratories (EU) Limited

76 1Dr. Reddy's Laboratories Inc DBA Dr. Reddy's Laboratories Tennessee LLC

77 10Dr. Reddy's Laboratories Limited

78 1Dr. Reddy's Laboratories Louisiana, LLC

79 1Dr. Reddy's Laboratories New York, Inc.

80 2Dr.Reddy's Laboratories Limited

81 1Industrias Quimicas Falcon De Mexico S.A. de C.V.

82 1Egis Pharmaceuticals PLC

83 1IOL Chemicals and Pharmaceuticals Ltd

84 1Laboratorium Ofichem B.V.

85 2Malladi Drugs & Pharmaceuticals Limited

86 1Mission Pharmacal Company

87 1BENECHIM SPRL

88 1COPRIMA , S.L.

89 1MOEHS CANTABRA, S.L.

90 1MOEHS CATALANA, S.L.

91 1Moehs BCN, S.L.

92 1PMC Isochem

93 1Phyton Biotech LLC

94 1Sharp

95 3Sharp Corporation

96 2SkyePharma Productions SAS

97 1VIRUPAKSHA ORGANICS LIMITED

98 1ZACH SYSTEM S.A.

99 1Zach System S.p.A.

100 1Zhejiang Hengkang Pharmaceutical Co., Ltd

101 1Aarti Pharmalabs Limited

102 1Beltapharm SPA

103 2Bioiberica

104 1Deccan Nutraceuticals

105 1Douglas Manufacturing Limited

106 1Ethypharm - Chateauneuf-en-Thymerais

107 1Ethypharm - Le Grand Quevilly

108 1ICE Pharma

109 1Olpha AS

110 1Mikart, LLC

111 3Neuland Laboratories Limited

112 1NORAMCO, Inc.

113 1Noramco

114 1Noramco, Inc.

115 1Noramco, LLC

116 1Pharmathen International S.A.

117 1Purisys LLC

118 1Quotient Sciences - Philadelphia, LLC

119 1Strides Alathur Private Limited

120 1Strides Chemicals Private Limited

121 4Strides Pharma Science

122 2Strides Pharma Science Limited

123 2Strides Pharma, Inc.

124 2Supriya Lifescience Ltd

125 1Towa Pharmaceutical

126 1Pharmacia & Upjohn Company LLC

127 1Synthokem Labs

128 1Synthokem Labs Private Limited

129 5Granules India Limited

130 1Granules Pharmaceuticals Inc.

131 1FARMHISPANIA SA

132 1Porton Pharma Solutions

133 1Pfanstiehl, Inc.

134 1Bal Pharma

135 1SCI Pharmtech, Inc.

136 1Chunghwa Chemical Synthesis & Biotech Co., Ltd.

137 1PHYTEX AUSTRALIA PTY LTD

138 1Sicor de Mexico S.A. de C.V.

139 2TAPI Puerto Rico, Inc.

140 1Teva API

141 1Teva API India Private Ltd.

142 1Halo Pharmaceutical Canada Inc.

143 1Halo Pharmaceutical Inc

144 1Haupt Pharma Amareg GmbH

145 1Haupt Pharma GmbH

146 1Haupt Pharma Latina Srl

147 1Haupt Pharma Wolfratshausen GmbH

148 1Haupt Pharma Wulfing GmbH

149 1Swiss Caps AG

150 1Mankind Pharma

151 1Honour Lab Limited

152 1Smithfield BioScience, Inc

153 1Smithfield BioScience, Inc.

154 1Unimark Remedies Limited

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PharmaCompass

01

GDUFA fees paid

USA

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : Alchem

Business Address : 25/2 Main Mathura Road Villa...

FEI Number : 3003310718

Country : India

Paid in : 2025

Alchem

02

GDUFA fees paid

USA

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : Finorga

Business Address : 497 Route de Givors Chasse-s...

FEI Number : 3002806990

Country : Germany

Paid in : 2024

Axplora CB

03

GDUFA fees paid

USA

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : Farmabios S.p.A.

Business Address : via Pavia 1 Gropello Cairoli...

FEI Number : 3002806965

Country : Germany

Paid in : 2024

Axplora CB

04

GDUFA fees paid

USA

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : PharmaZell (India) Private Lim...

Business Address : Plot No. B5 & B6, MEPZ, Tamb...

FEI Number : 3003602532

Country : Germany

Paid in : 2024

Axplora CB

05

GDUFA fees paid

USA

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : PharmaZell (India) Private Lim...

Business Address : Plot No.115, Ramky Pharma Ci...

FEI Number : 3008248967

Country : Germany

Paid in : 2024

Axplora CB

06

GDUFA fees paid

USA

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : PharmaZell GmbH

Business Address : Rosenheimer Str.43 Raubling ...

FEI Number : 3003725792

Country : Germany

Paid in : 2024

Axplora CB

07

GDUFA fees paid

USA

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : Sichuan Credit Chemwerth Pharm...

Business Address : Industrial Park, Fuji Town, ...

FEI Number : 3006168710

Country : U.S.A

Paid in : 2022

Chemwerth Compnay Banner

08

GDUFA fees paid

USA

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : EUROAPI FRANCE

Business Address : Rue de Verdun SAINT AUBIN LE...

FEI Number : 1000370849

Country : France

Paid in : 2025

EUROAPI Compnay Banner

09

GDUFA fees paid

USA

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : EUROAPI Hungary Ltd.

Business Address : To utca 1-5 Budapest Budapes...

FEI Number : 3002806675

Country : France

Paid in : 2025

EUROAPI Compnay Banner

10

GDUFA fees paid

USA

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : EUROAPI ITALY SRL

Business Address : VIA ANGELO TITI 22/26 Italy

FEI Number : 3003677892

Country : France

Paid in : 2025

EUROAPI Compnay Banner