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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 Chemical Company Inc

07 1Mission | CDMO

08 1PMC Isochem

09 1Renejix

10 1Sharp

11 1Skyepharma

12 1ZACH System SA

13 1M2i Group

14 1Mikart

15 1Neuland Laboratories

16 1Quotient Sciences

17 1ACTA Laboratories Inc

18 1ARx

19 1Acceleration Laboratory Services

20 1Adare Pharma Solutions

21 1Admix Pharma Laboratories, LLC

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 1Ardena

32 1Arevipharma

33 1Ascent Innovative Medicines

34 1Ash Stevens, Inc.

35 2Avaca Pharma

36 1Avivia

37 1Basic Pharma

38 1Bellen Chemistry

39 1Bio-Technology General Israel Ltd.

40 1Biolink LifeSciences

41 1Bioplus Life Sciences

42 1BirgiMefar Group

43 1Bluepharma

44 1Boston Analytical

45 1CLEARSYNTH LABS LIMITED

46 1Cambrex Corporation

47 1Catalent Pharma Solutions

48 1Cebiphar

49 1ChemCon GmbH

50 1Chromcore Lifesciences

51 1Crenza Pharma

52 1Curia

53 1Curida AS

54 1Curtis Health Caps

55 1Cyndea Pharma S.L

56 1DPT Laboratories, Ltd

57 1Dishman Carbogen Amcis

58 1Diverchim S.A.

59 1Doctor's Analytical Laboratories

60 1Era Pharma Solutions

61 1Etico Lifesciences

62 1Eurofins BioPharma Services

63 1Evotec

64 1Flagship Biotech International Pvt. Ltd

65 1Fresenius SE & Co. KGaA

66 1FumoPrep

67 1GALENIX INNOVATIONS

68 1GALIEN LPS

69 1GRAM Laboratory Inc

70 1Globela Pharma

71 1Healios Labs

72 1JGL d.d

73 1JSL Health Sciences

74 1KriSan Biotech

75 1Labiana Life Sciences S.A

76 1Lamda Laboratories

77 1Legacy Pharmaceuticals Switzerland

78 1Lonza Capsugel

79 1Lubrizol Life Science Health

80 1M2M Pharmaceuticals Ltd

81 1Madras Pharmaceuticals

82 1Maithili Life Sciences

83 2Megsan Labs Private Limited

84 1Menadiona

85 1Merck Millipore

86 1Mithra CDMO

87 1Neopharm Labs Inc

88 1Novick Biosciences

89 1Nutrasource

90 1ORIT LABS LLC

91 1Olive Healthcare

92 1Oncomed Manufacturing A.S

93 1Onyx Scientific

94 1Ortiv-Q3 Research

95 1Osmopharm

96 1PSR Pharma Science and Research

97 1PYRAMID Laboratories, Inc

98 1Pace Analytical Services, LLC

99 1PharmaVize NV

100 1Prague Scientific

101 1Progenerics Pharma Pvt Ltd

102 1Provepharm Life Solutions

103 1Proveris Scientific

104 1QUINTA-ANALYTICA s.r.o

105 2Quantex Laboratories

106 1RD Laboratories

107 1Rafarm S.A

108 1Recipharm AB

109 1Ropack Inc

110 1SEQUENT SCIENTIFIC LTD

111 1SGS Life Sciences

112 1STABICON LIFE SCIENCE PVT LTD

113 1Sai Life Sciences Limited

114 1Saneca Pharmaceuticals

115 1Santa S.A

116 1ScinoPharm Taiwan, Ltd

117 1Servier

118 2Shijiazhuang Rainbowlabs Pharmaceutical Technology

119 1Siegfried AG

120 1Societal CDMO

121 1Softigel Procaps

122 1Solara Active Pharma Sciences

123 1Solvias

124 1Stason Pharmaceuticals, Inc.

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 1Zenvision Pharma LLP

134 1mKnal Global Solutions

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