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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 1Metrochem API Private Limited

50 2Nuray Chemicals Private Limited

51 2Orion Corporation

52 1PCAS

53 1PCAS Finland Oy

54 3SPI PHARMA

55 1CU Chemie Uetikon GmbH

56 1Novacyl

57 1Novacyl Thailand Limited

58 1Novacyl Wuxi Pharmaceutical Co. Ltd.

59 1PolyCarbon Industries, Inc.

60 1Suanfarma Italia

61 2SYMBIOTEC PHARMALAB PRIVATE LIMITED

62 1Perrigo Israel Pharmaceuticals LTD.

63 1Wavelength Enterprises Ltd.

64 2Cohance Lifesciences

65 2RA CHEM PHARMA LIMITED

66 1ZCL Chemicals Limited

67 1Cayman Chemical Company, Inc

68 1Cayman Pharma s.r.o.

69 1Chemische Fabrik Berg GmbH

70 1Chirogate International Inc.

71 1CORAL DRUGS PRIVATE LIMITED

72 1Dr Reddy's Laboratories Limited

73 1Dr. Reddy's Laboratories (EU) Limited

74 1Dr. Reddy's Laboratories Inc DBA Dr. Reddy's Laboratories Tennessee LLC

75 10Dr. Reddy's Laboratories Limited

76 1Dr. Reddy's Laboratories Louisiana, LLC

77 1Dr. Reddy's Laboratories New York, Inc.

78 2Dr.Reddy's Laboratories Limited

79 1Industrias Quimicas Falcon De Mexico S.A. de C.V.

80 1Egis Pharmaceuticals PLC

81 1IOL Chemicals and Pharmaceuticals Ltd

82 1Laboratorium Ofichem B.V.

83 2Malladi Drugs & Pharmaceuticals Limited

84 1Mission Pharmacal Company

85 1BENECHIM SPRL

86 1COPRIMA , S.L.

87 1MOEHS CANTABRA, S.L.

88 1MOEHS CATALANA, S.L.

89 1Moehs BCN, S.L.

90 1PMC Isochem

91 1Phyton Biotech LLC

92 1Sharp

93 3Sharp Corporation

94 2SkyePharma Productions SAS

95 1VIRUPAKSHA ORGANICS LIMITED

96 1ZACH SYSTEM S.A.

97 1Zach System S.p.A.

98 1Zhejiang Hengkang Pharmaceutical Co., Ltd

99 1Aarti Pharmalabs Limited

100 1Beltapharm SPA

101 2Bioiberica

102 1Deccan Nutraceuticals

103 1Douglas Manufacturing Limited

104 1Ethypharm - Chateauneuf-en-Thymerais

105 1Ethypharm - Le Grand Quevilly

106 1ICE Pharma

107 1Olpha AS

108 1Mikart, LLC

109 3Neuland Laboratories Limited

110 1NORAMCO, Inc.

111 1Noramco

112 1Noramco, Inc.

113 1Noramco, LLC

114 1Pharmathen International S.A.

115 1Purisys LLC

116 1Quotient Sciences - Philadelphia, LLC

117 1Strides Alathur Private Limited

118 1Strides Chemicals Private Limited

119 4Strides Pharma Science

120 2Strides Pharma Science Limited

121 2Strides Pharma, Inc.

122 2Supriya Lifescience Ltd

123 1Towa Pharmaceutical

124 1Pharmacia & Upjohn Company LLC

125 1Synthokem Labs

126 1Synthokem Labs Private Limited

127 5Granules India Limited

128 1Granules Pharmaceuticals Inc.

129 1Pfanstiehl, Inc.

130 1SCI Pharmtech, Inc.

131 1Chunghwa Chemical Synthesis & Biotech Co., Ltd.

132 1PHYTEX AUSTRALIA PTY LTD

133 1Sicor de Mexico S.A. de C.V.

134 2TAPI Puerto Rico, Inc.

135 1Teva API

136 1Teva API India Private Ltd.

137 1Haupt Pharma Amareg GmbH

138 1Haupt Pharma GmbH

139 1Haupt Pharma Latina Srl

140 1Haupt Pharma Wolfratshausen GmbH

141 1Haupt Pharma Wulfing GmbH

142 1Swiss Caps AG

143 1Mankind Pharma

144 1Honour Lab Limited

145 1Smithfield BioScience, Inc

146 1Smithfield BioScience, Inc.

147 3Unimark Remedies Limited

148 1COSMA SpA

149 1AMSA ANONIMA MATERIE SINTETICHE & AFFINI SPA

150 1Sichuan Qingmu Pharmaceutical Co., Ltd.

151 1Maithri Drugs Private Limited

152 1Maithri Laboratories Private Limited

153 4Lupin Manufacturing Solutions

154 1Swati Spentose

155 1ENALTEC LABS PVT. LTD.

156 13Enaltec Labs

157 3Prime European Therapeuticals SpA dba Euticals SpA

158 1FAREVA Unterach GmbH

159 2Fareva

160 1Farmea

161 8Siegfried AG

162 1Excella GmbH & Co. KG

163 1Vital Laboratories

164 1Indena India Private Limited

165 1Indena SpA

166 2Alkaloids Private Limited

167 1LUNDBECK PHARMACEUTICALS ITALY SPA

168 1Symbiotica Speciality Ingredients Sdn.Bhd.

169 1AMRI India Private Limited

170 1Curia

171 2Curia Italy S.r.l.

172 1Curia Missouri, Inc.

173 1Curia New Mexico, LLC

174 1Curia New York, Inc.

175 1Curia Spain, S.A.U.

176 1Curia Wisconsin, Inc.

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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 : 2026

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, Tamba...

FEI Number : 3003602532

Country : Germany

Paid in : 2026

Axplora CB

05

GDUFA fees paid

USA

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

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

Business Address : Plot No.115, Visakha Pharmac...

FEI Number : 3008248967

Country : Germany

Paid in : 2026

Axplora CB

06

GDUFA fees paid

USA

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : PharmaZell GmbH

Business Address : Rosenheimer Strasse 43 Raubl...

FEI Number : 3003725792

Country : Germany

Paid in : 2026

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