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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 1Johnson Matthey Inc.

33 1Johnson Matthey Pharmaceutical Services

34 1Macfarlan Smith Limited

35 1Veranova, L.P.

36 1ZENARA PHARMA PRIVATE LIMITED

37 1Aspen Bad Oldesloe GmbH

38 1Aspen Oss B.V.

39 1Aspen SA OSD Operations (Pty) Ltd

40 1Aspen SA Sterile Operations

41 1Aspen Port Elizabeth (Pty) Ltd

42 1BACHEM SA

43 1Bachem AG

44 3Bachem Americas, Inc.

45 1Bora Pharmaceutical Laboratories Inc.

46 1Bora Pharmaceuticals

47 1Evonik Nutrition & Care GmbH

48 1Evonik Rexim (Nanning) Pharmaceutical Co., Ltd.

49 1Farmak A.S.

50 1Fermion Oy Hanko Plant

51 1Fermion Oy Oulu Plant

52 1Fine Chemicals Corporation (Pty) Ltd

53 2Nuray Chemicals Private Limited

54 2Orion Corporation

55 1PCAS

56 1PCAS Finland Oy

57 3SPI PHARMA

58 1CU Chemie Uetikon GmbH

59 1Novacyl

60 1Novacyl Thailand Limited

61 1Novacyl Wuxi Pharmaceutical Co. Ltd.

62 1PolyCarbon Industries, Inc.

63 1Suanfarma Italia

64 2SYMBIOTEC PHARMALAB PRIVATE LIMITED

65 1Perrigo Israel Pharmaceuticals LTD.

66 1Wavelength Enterprises Ltd.

67 1Astral SteriTech Private Limited

68 2Cohance Lifesciences

69 2RA CHEM PHARMA LIMITED

70 1ZCL Chemicals Limited

71 1Cayman Chemical Company, Inc

72 1Cayman Pharma s.r.o.

73 1Centrient Pharmaceuticals India Private Limited

74 1Centrient Pharmaceuticals Spain, SA

75 1Chemische Fabrik Berg GmbH

76 1Chirogate lnternatianal Inc.

77 1CORAL DRUGS PRIVATE LIMITED

78 1Dr Reddy's Laboratories Limited

79 1Dr. Reddy's Laboratories (EU) Limited

80 1Dr. Reddy's Laboratories Inc DBA Dr. Reddy's Laboratories Tennessee LLC

81 10Dr. Reddy's Laboratories Limited

82 1Dr. Reddy's Laboratories Louisiana, LLC

83 1Dr. Reddy's Laboratories New York, Inc.

84 2Dr.Reddy's Laboratories Limited

85 1Industrias Quimicas Falcon De Mexico S.A. de C.V.

86 1Egis Pharmaceuticals PLC

87 1Akorn AG

88 1Excella GmbH & Co. KG

89 1VALDEPHARM

90 1IOL Chemicals and Pharmaceuticals Ltd

91 1Laboratorium Ofichem B.V.

92 2Malladi Drugs & Pharmaceuticals Limited

93 1Mission Pharmacal Company

94 1BENECHIM SPRL

95 1COPRIMA , S.L.

96 1MOEHS CANTABRA, S.L.

97 1MOEHS CATALANA, S.L.

98 1Moehs BCN, S.L.

99 1PMC Isochem

100 1Phyton Biotech LLC

101 1Sharp

102 3Sharp Corporation

103 2SkyePharma Productions SAS

104 1VIRUPAKSHA ORGANICS LIMITED

105 1ZACH SYSTEM S.A.

106 1Zach System S.p.A.

107 1Zhejiang Hengkang Pharmaceutical Co., Ltd

108 1Aarti Pharmalabs Limited

109 2Bioiberica

110 1Deccan Nutraceuticals

111 1Douglas Manufacturing Limited

112 1Ethypharm - Chateauneuf-en-Thymerais

113 1Ethypharm - Le Grand Quevilly

114 1ICE Pharma

115 1Olainfarm JSC

116 1Mikart, LLC

117 3Neuland Laboratories Limited

118 1NORAMCO, Inc.

119 1Noramco

120 1Noramco, Inc.

121 1Noramco, LLC

122 1Pharmathen International S.A.

123 1Purisys LLC

124 1Quotient Sciences - Philadelphia, LLC

125 4Strides Pharma Science

126 2Strides Pharma Science Limited

127 2Supriya Lifescience Ltd

128 1Towa Pharmaceutical

129 1Pharmacia & Upjohn Company LLC

130 1Synthokem Labs

131 1Synthokem Labs Private Limited

132 4Granules India Limited

133 1Granules Pharmaceuticals Inc.

134 1FARMHISPANIA SA

135 1Porton Pharma Solutions

136 1Pfanstiehl, Inc.

137 1Bal Pharma

138 1SCI Pharmtech, Inc.

139 1Chunghwa Chemical Synthesis & Biotech Co., Ltd.

140 1PHYTEX AUSTRALIA PTY LTD

141 1Sicor de Mexico S.A. de C.V.

142 2TAPI Puerto Rico, Inc.

143 1Teva API

144 1Teva API India Private Ltd.

145 1Halo Pharmaceutical Canada Inc.

146 1Halo Pharmaceutical Inc

147 1Haupt Pharma Amareg GmbH

148 1Haupt Pharma GmbH

149 1Haupt Pharma Latina Srl

150 1Haupt Pharma Wolfratshausen GmbH

151 1Haupt Pharma Wulfing GmbH

152 1Swiss Caps AG

153 1Mankind Pharma

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PharmaCompass

01

GDUFA fees paid

USA

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : Alchem International Private L...

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