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Analytical Method Development and Validation Before the analysis of leachables samples, a test method must be developed and validated to ensure that the analytes of interest are not obscured or affected by the formulation of the drug product. Appropriate analytes of interest for testing are to be dertermined. Drawing from resources available in literature, or performing extractables profiles in chemistry laboratory, specific analytes of interest for a drug product are determined. Methods are dev

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01 1Famar

02 1Aspen API

03 1Bachem AG

04 1Fermion Oy

05 1Seqens

06 1Cayman Pharma s.r.o

07 1Mission | CDMO

08 1PMC Isochem

09 1Sharp

10 1Skyepharma

11 1ZACH System SA

12 1Mikart

13 1NanoAlvand

14 1Neuland Laboratories

15 1Quotient Sciences

16 1ACTA Laboratories Inc

17 1ARx

18 1Acceleration Laboratory Services

19 1Adare Pharma Solutions

20 1Admix Pharma Laboratories, LLC

21 1Adragos Pharma

22 1Aizant Drug Research Solutions Pvt. Ltd.

23 1AlbyPharma

24 1Almelo

25 2Anacipher

26 1Angelini Pharma

27 1Appcure Labs

28 2Aragen Life Sciences

29 1Arbro Pharmaceuticals Pvt. Ltd

30 1Arcinova

31 1Arevipharma

32 1Ascent Innovative Medicines

33 1Ash Stevens

34 2Avaca Pharma

35 1Avivia

36 1Basic Pharma

37 1Bellen Chemistry

38 1Bio-Technology General Israel Ltd.

39 1Biolink LifeSciences

40 1Bioplus Life Sciences

41 1BirgiMefar Group

42 1Bluepharma

43 1Boston Analytical

44 1Cambrex Corporation

45 1Catalent Pharma Solutions

46 1Cebiphar

47 1ChemCon GmbH

48 1Chromcore Lifesciences

49 1Clearsynth Labs Limited

50 1Crenza Pharma

51 1Curia

52 1Curida AS

53 1Curtis Health Caps

54 1Cyndea Pharma S.L

55 1DPT Laboratories, Ltd

56 1Dishman Carbogen Amcis

57 1Diverchim

58 1Doctor's Analytical Laboratories

59 1Era Pharma Solutions

60 1Etico Lifesciences

61 1Eurofins BioPharma Services

62 1Evotec

63 1Flagship Biotech International Pvt. Ltd

64 1Fresenius SE & Co. KGaA

65 1FumoPrep

66 1GALENIX INNOVATIONS

67 1GALIEN LPS

68 1GRAM Laboratory Inc

69 1Globela Pharma

70 1Healios Labs

71 1JGL d.d

72 1JSL Health Sciences

73 1KriSan Biotech

74 1Labiana Life Sciences S.A

75 1Legacy Pharmaceuticals Switzerland

76 1Lonza Capsugel

77 1Lubrizol Life Science Health

78 1M2M Pharmaceuticals Ltd

79 1M2i Group

80 1Madras Pharmaceuticals

81 1Maithili Life Sciences

82 2Megsan Labs Private Limited

83 1Menadiona

84 1Merck Millipore

85 1Mithra CDMO

86 1Neopharm Labs Inc

87 1Novick Biosciences

88 1Nutrasource

89 1ORIT LABS LLC

90 1Olive Healthcare

91 1Oncomed Manufacturing A.S

92 1Onyx Scientific

93 1Ortiv-Q3 Research

94 1Osmopharm

95 1PSR Pharma Science and Research

96 1PYRAMID Laboratories, Inc

97 1Pace Analytical Services, LLC

98 1PharmaVize NV

99 1Prague Scientific

100 1Progenerics Pharma Pvt Ltd

101 1Provepharm Life Solutions

102 1Proveris Scientific

103 1QUINTA-ANALYTICA s.r.o

104 2Quantex Laboratories

105 1RD Laboratories

106 1Rafarm S.A

107 1Recipharm AB

108 1Ropack Inc

109 1SGS Life Sciences

110 1STABICON LIFE SCIENCE PVT LTD

111 1Sai Life Sciences Limited

112 1Saneca Pharmaceuticals

113 1Santa

114 1ScinoPharm Taiwan Ltd

115 1SeQuent Scientific

116 1Servier

117 2Shijiazhuang Rainbowlabs Pharmaceutical Technology

118 1Siegfried AG

119 1Societal CDMO

120 1Softigel Procaps

121 1Solara Active Pharma Sciences

122 1Solvias

123 1Stason Pharmaceuticals, Inc.

124 1Stira Pharmaceuticals

125 1Sushen Medicamentos Pvt. Ltd

126 1Symbiosis Pharmaceutical Services

127 1Tapemark Company

128 1Tepnel Pharma Services

129 1UQUIFA

130 1Unither Pharmaceuticals

131 1Vitas Analytical Services

132 1Zelmic

133 1mKnal Global Solutions

134 1Blank

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