FDA Faults Cadila Healthcare - C&EN Global Enterprise (ACS

Cadila Healthcare, a major Indian generic drug company, has become the latest pharmaceutical manufacturer with a plant in India to be issued a U.S. FD...
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NEWS OF THE WEEK

PERIODIC TABLE UPDATED NUCLEAR CHEMISTRY: Four elements

added to complete the seventh row

1

H 3

4

Li

Be

11

12

Na Mg 19

20

K

Ca

37

38

Rb

Sr

55

56

Cs Ba 87

88

Fr

Ra

the seventh row of the periodic table is officially full, the International Union of Pure & Applied Chemistry (IUPAC) announced on Dec. 30. A joint committee made up of IUPAC and the International Union of 2 Pure & Applied PhysHe IUPAC approved the addition 10 ics gave its stamp of of elements 113, 115, 117, and 118 B5 C6 N7 O8 F9 Ne (yellow) to the periodic table. approval, and IUPAC 13 14 15 16 17 18 Al Si P S Cl Ar temporarily gave ele21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 ment 113 the name unSc Ti V Cr Mn Fe Co Ni Cu Zn Ga Ge As Se Br Kr untrium (Uut), 115 the 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 Y Zr Nb Mo Tc Ru Rh Pd Ag Cd In Sn Sb Te I Xe name ununpentium 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 Hf Ta W Re Os Ir Pt Au Hg Tl Pb Bi Po At Rn (Uup), 117 the name 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 ununseptium (Uus), Rf Db Sg Bh Hs Mt Ds Rg Cn Uut Fl Uup Lv Uus Uuo and 118 the name ununoctium (Uuo). 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 The people credited La Ce Pr Nd Pm Sm Eu Gd Tb Dy Ho Er Tm Yb Lu for first discovering an 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 Ac Th Pa U Np Pu Am Cm Bk Cf Es Fm Md No Lr element get the right

FDA FAULTS CADILA HEALTHCARE DRUG SAFETY: Another big Indian

drug firm fails to meet standards

NO ONE SPARED Recent recipients of FDA warning letters in India include prominent local and foreign firms.

C

ADILA HEALTHCARE, a major Indian generic

drug company, has become the latest pharmaceutical manufacturer with a plant in India to be issued a U.S. FDA warning letter for failing to meet the regulatory standards of the U.S. Warning letters are issued to COMPANY MONTH RECEIVED firms that, during an inspection by Cadila December FDA officials, are found to breach Sun Pharma December pharmaceutical manufacturing regulations. Recipients of the letters Dr. Reddy’s November are often, but not always, banned in Sandoz November the U.S. from selling finished drugs Pan Drugs September and active ingredients made at their Unimark Remedies September noncompliant facilities. Mylan August In a statement to the Bombay Mahendra Chemicals July Stock Exchange, Cadila acknowledged receiving a warning letter Cadila February covering two plants, one making active pharmaceutical ingredients NOTE: List is not comprehensive. SOURCE: FDA CEN.ACS.ORG

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C&EN

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ITH THE ADDITION of four new elements,

to propose a permanent name and symbol. For element 113, that honor goes to scientists at Japan’s RIKEN research institution. It will be the first time that Asian researchers name an element. For the other three elements, credit and naming rights go to European-American collaborations involving Russia’s Joint Institute for Nuclear Research and the U.S. Lawrence Livermore and Oak Ridge national laboratories. IUPAC plans to issue a new periodic table with the four added elements and other updates by the end of January, says Lynn M. Soby, IUPAC’s executive director. She hopes that the elements will receive their final names in about six months, at which point IUPAC will again update the table. What fascinates researchers about superheavy elements in the seventh row and beyond is their potential chemistry, says Dawn Shaughnessy, principal investigator for the Heavy Element Group at Lawrence Livermore National Laboratory. As the number of protons in an atomic nucleus increases, electrons speed up and generate relativistic effects that alter orbital energy levels. That could mean that group reactivity trends don’t hold as elements get heavier. But doing chemistry on short-lived atoms created one at a time in heavy-ion accelerators is challenging. “The periodic table says that 118 is a noble gas. How could we determine that based on a single atom?” Shaughnessy asks.—JYLLIAN KEMSLEY

and the other formulations. The firm did not say what violations were alleged, and FDA hasn’t released the letter. Other prominent Indian drug firms have received warning letters in the past year. The list includes Sun Pharmaceutical Industries, which is India’s largest drug manufacturer, and Dr. Reddy’s Laboratories. FDA also issued warning letters last year detailing flaws at Indian plants owned by U.S.-based Mylan and the Swiss generic drug producer Sandoz. The FDA letters cite a range of shortcomings at Indian plants. In many cases, such as the most recent letter issued to Sun, companies are accused of failing to maintain proper records, a deficiency that impedes inspectors’ efforts to determine if required manufacturing procedures are followed. At other companies, such as Pan Drugs, inspectors saw facilities so poorly maintained that pigeons roamed inside. Top managers at some Indian drug firms pursue profitability as their main objective even if it comes at the expense of quality, claims Helena Champion, principal consultant at Drug Quality Assurance, a Boston-based drug manufacturing quality and regulatory compliance firm. The managers flout the rules because “poor- or unsafe-quality product is not likely to be discovered and attributed to their company.” Rather, she says, many reckon that the U.S. buyers and distributors of their products will be blamed for any quality problems.—JEAN-FRANÇOIS TREMBLAY

JANUARY 11, 2016